Publications
194 results found
Gong J, Fellmeth G, Quigley MA, et al., 2023, Prevalence and risk factors for postnatal mental health problems in mothers of infants admitted to neonatal care: Analysis of two population-based surveys in England, BMC Pregnancy and Childbirth, Vol: 23, Pages: 1-16, ISSN: 1471-2393
BackgroundPrevious research suggests that mothers whose infants are admitted to neonatal units (NNU) experience higher rates of mental health problems compared to the general perinatal population. This study examined the prevalence and factors associated with postnatal depression, anxiety, post-traumatic stress (PTS), and comorbidity of these mental health problems for mothers of infants admitted to NNU, six months after childbirth.MethodsThis was a secondary analysis of two cross-sectional, population-based National Maternity Surveys in England in 2018 and 2020. Postnatal depression, anxiety, and PTS were assessed using standardised measures. Associations between sociodemographic, pregnancy- and birth-related factors and postnatal depression, anxiety, PTS, and comorbidity of these mental health problems were explored using modified Poisson regression and multinomial logistic regression.ResultsEight thousand five hundred thirty-nine women were included in the analysis, of whom 935 were mothers of infants admitted to NNU. Prevalence of postnatal mental health problems among mothers of infants admitted to NNU was 23.7% (95%CI: 20.6–27.2) for depression, 16.0% (95%CI: 13.4–19.0) for anxiety, 14.6% (95%CI: 12.2–17.5) for PTS, 8.2% (95%CI: 6.5–10.3) for two comorbid mental health problems, and 7.5% (95%CI: 5.7–10.0) for three comorbid mental health problems six months after giving birth. These rates were consistently higher compared to mothers whose infants were not admitted to NNU (19.3% (95%CI: 18.3–20.4) for depression, 14.0% (95%CI: 13.1–15.0) for anxiety, 10.3% (95%CI: 9.5–11.1) for PTS, 8.5% (95%CI: 7.8–9.3) for two comorbid mental health problems, and 4.2% (95%CI: 3.6–4.8) for three comorbid mental health problems six months after giving birth. Among mothers of infants admitted to NNU (N = 935), the strongest risk factors for mental health problems were having a long-term mental health probl
Molloy EJ, Nakra N, Gale C, et al., 2023, Multisystem inflammatory syndrome in children (MIS-C) and neonates (MIS-N) associated with COVID-19: optimizing definition and management, Pediatric Research, Vol: 93, Pages: 1499-1508, ISSN: 0031-3998
During the SARS-CoV-2-associated infection (COVID-19), pandemic initial reports suggested relative sparing of children inversely related to their age. Children and neonates have a decreased incidence of SARS-CoV-2 infection, and if infected they manifested a less severe phenotype, in part due to enhanced innate immune response. However, a multisystem inflammatory syndrome in children (MIS-C) or paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 emerged involving coronary artery aneurysms, cardiac dysfunction, and multiorgan inflammatory manifestations. MIS-C has many similarities to Kawasaki disease and other inflammatory conditions and may fit within a spectrum of inflammatory conditions based on immunological results. More recently neonates born to mothers with SARS-CoV-2 infection during pregnancy demonstrated evidence of a multisystem inflammatory syndrome with raised inflammatory markers and multiorgan, especially cardiac dysfunction that has been described as multisystem inflammatory syndrome in neonates (MIS-N). However, there is a variation in definitions and management algorithms for MIS-C and MIS-N. Further understanding of baseline immunological responses to allow stratification of patient groups and accurate diagnosis will aid prognostication, and inform optimal immunomodulatory therapies. IMPACT: Multisystem inflammatory system in children and neonates (MIS-C and MIS-N) post COVID require an internationally recognized consensus definition and international datasets to improve management and plan future clinical trials. This review incorporates the latest review of pathophysiology, clinical information, and management of MIS-C and MIS-N. Further understanding of the pathophysiology of MIS-C and MIS-N will allow future targeted therapies to prevent and limit clinical sequelae.
Hayes R, Hartnett J, Semova G, et al., 2023, Neonatal sepsis definitions from randomised clinical trials, Pediatric Research, Vol: 93, Pages: 1141-1148, ISSN: 0031-3998
Introduction:Neonatal sepsis is a leading cause of infant mortality worldwide with non-specific and varied presentation. We aimed to catalogue the current definitions of neonatal sepsis in published randomised controlled trials (RCTs).Method:A systematic search of the Embase and Cochrane databases was performed for RCTs which explicitly stated a definition for neonatal sepsis. Definitions were sub-divided into five primary criteria for infection (culture, laboratory findings, clinical signs, radiological evidence and risk factors) and stratified by qualifiers (early/late-onset and likelihood of sepsis).Results:Of 668 papers screened, 80 RCTs were included and 128 individual definitions identified. The single most common definition was neonatal sepsis defined by blood culture alone (n = 35), followed by culture and clinical signs (n = 29), and then laboratory tests/clinical signs (n = 25). Blood culture featured in 83 definitions, laboratory testing featured in 48 definitions while clinical signs and radiology featured in 80 and 8 definitions, respectively.Discussion:A diverse range of definitions of neonatal sepsis are used and based on microbiological culture, laboratory tests and clinical signs in contrast to adult and paediatric sepsis which use organ dysfunction. An international consensus-based definition of neonatal sepsis could allow meta-analysis and translate results to improve outcomes.
Sturrock S, Ali S, Gale C, et al., 2023, Neonatal outcomes and indirect consequences following maternal SARS-CoV-2 infection in pregnancy: a systematic review, BMJ Open, Vol: 13, Pages: 1-8, ISSN: 2044-6055
Objectives: Identify the association between maternal SARS-CoV-2 infection in pregnancy and individual neonatal morbidities and outcomes, particularly longer-term outcomes such as neurodevelopment.Design: Systematic review of outcomes of neonates born to pregnant women diagnosed with a SARS-CoV-2 infection at any stage during pregnancy, including asymptomatic women.Data sources: MEDLINE, Embase, Global Health, WHOLIS and LILACS databases, last searched 28th July 2021.Eligibility criteria: Case-control and cohort studies published after 1st January 2020, including pre-print articles were included. Study outcomes included neonatal mortality and morbidity, preterm birth, Caesarean delivery, small for gestational age, admission to neonatal intensive care unit, level of respiratory support required, diagnosis of culture-positive sepsis, evidence of brain injury, necrotising enterocolitis, visual or hearing impairment, neurodevelopmental outcomes, and feeding method. These were selected according to a Core Outcome Set.Data extraction and synthesis: Data were extracted into Microsoft Excel by 2 researchers, with statistical analysis completed using IBM SPSS. Risk of bias was assessed using a modified Newcastle-Ottawa scale.Results: The search returned 3234 papers, from which 204 were included with a total of 45,646 infants born to mothers with SARS-CoV-2 infection during pregnancy across 36 countries. We found limited evidence of an increased risk of some neonatal morbidities, including respiratory disease. There was minimal evidence from low-income settings (1 study) and for neonatal outcomes following first trimester infection (17 studies). Neonatal mortality was very rare. Preterm birth, neonatal unit admission and small for gestational age status were more common in infants born following maternal SARS-CoV-2 infection in pregnancy in most larger studies.Conclusions: There are limited data on neonatal morbidity and mortality following maternal SARS-CoV-2 infectio
Smith ER, Oakley E, Grandner GW, et al., 2023, Clinical risk factors of adverse outcomes among women with COVID-19 in the pregnancy and postpartum period: A sequential, prospective meta-analysis, American Journal of Obstetrics and Gynecology, Vol: 228, Pages: 161-177, ISSN: 0002-9378
OBJECTIVE: This sequential, prospective meta-analysis (sPMA) sought to identify risk factors among pregnant and postpartum women with COVID-19 for adverse outcomes related to: disease severity, maternal morbidities, neonatal mortality and morbidity, adverse birth outcomes. DATA SOURCES: We prospectively invited study investigators to join the sPMA via professional research networks beginning in March 2020. STUDY ELIGIBILITY CRITERIA: Eligible studies included those recruiting at least 25 consecutive cases of COVID-19 in pregnancy within a defined catchment area. STUDY APPRAISAL AND SYNTHESIS METHODS: We included individual patient data from 21 participating studies. Data quality was assessed, and harmonized variables for risk factors and outcomes were constructed. Duplicate cases were removed. Pooled estimates for the absolute and relative risk of adverse outcomes comparing those with and without each risk factor were generated using a two-stage meta-analysis. RESULTS: We collected data from 33 countries and territories, including 21,977 cases of SARS-CoV-2 infection in pregnancy or postpartum. We found that women with comorbidities (pre-existing diabetes, hypertension, cardiovascular disease) versus those without were at higher risk for COVID-19 severity and pregnancy health outcomes (fetal death, preterm birth, low birthweight). Participants with COVID-19 and HIV were 1.74 times (95% CI: 1.12, 2.71) more likely to be admitted to the ICU. Pregnant women who were underweight before pregnancy were at higher risk of ICU admission (RR 5.53, 95% CI: 2.27, 13.44), ventilation (RR 9.36, 95% CI: 3.87, 22.63), and pregnancy-related death (RR 14.10, 95% CI: 2.83, 70.36). Pre-pregnancy obesity was also a risk factor for severe COVID-19 outcomes including ICU admission (RR 1.81, 95% CI: 1.26,2.60), ventilation (RR 2.05, 95% CI: 1.20,3.51), any critical care (RR 1.89, 95% CI: 1.28,2.77), and pneumonia (RR 1.66, 95% CI: 1.18,2.33). Anemic pregnant women with COVID-19 also had in
Lammons W, Moss R, Bignell C, et al., 2023, Involving multiple stakeholders in assessing and reviewing a novel data visualization tool for a national neonatal data asset, BMJ Health & Care Informatics, Vol: 30, Pages: 1-7, ISSN: 2632-1009
Objectives We involved public and professional stakeholders to assess a novel data interrogation tool, the Neonatal Health Intelligence Tool, for a National Data Asset, the National Neonatal Research Database.Methods We recruited parents, preterm adults, data managers, clinicians, network managers and researchers (trialists and epidemiologists) for consultations demonstrating a prototype tool and semi-structured discussion. A thematic analysis of consultations is reported by stakeholder group.Results We held nine on-line consultations (March–December 2021), with 24 stakeholders: parents (n=8), preterm adults (n=2), data managers (n=3), clinicians (n=3), network managers (n=2), triallists (n=3) and epidemiologists (n=3). We identified four themes from parents/preterm adults: struggling to consume information, Dads and data, bring data to life and yearning for predictions; five themes from data managers/clinicians/network managers: benchmarking, clinical outcomes, transfers and activity, the impact of socioeconomic background and ethnicity, and timeliness of updates and widening availability; and one theme from researchers: interrogating the data.Discussion Other patient and public involvement (PPI) studies have reported that data tools generate concerns; our stakeholders had none. They were unanimously supportive and enthusiastic, citing visualisation as the tool’s greatest strength. Stakeholders had no criticisms; instead, they recognised the tool’s potential and wanted more features. Parents saw the tool as an opportunity to inform themselves without burdening clinicians, while clinicians welcomed an aid to explaining potential outcomes to parents.Conclusion All stakeholder groups recognised the need for the tool, praising its content and format. PPI consultations with all key groups, and their synthesis, illustrated desire for additional uses from it.
Lugg-Widger FV, Barlow C, Cannings-John R, et al., 2023, The practicalities of adapting UK maternity clinical information systems for observational research: experiences of the POOL study, International Journal of Population Data Science, Vol: 8, ISSN: 2399-4908
BackgroundUsing routinely collected clinical data for observational research is an increasingly important method for data collection, especially when rare outcomes are being explored. The POOL study was commissioned to evaluate the safety of waterbirth in the UK using routine maternity and neonatal clinical data. This paper describes the design, rationale, set-up and pilot for this data linkage study using bespoke methods.MethodsClinical maternity information systems hold many data items of value for research purposes, but often lack specific data items required for individual studies. This study used the novel method of amending an existing clinical maternity database for the purpose of collecting additional research data fields. In combination with the extraction of existing data fields, this maximised the potential use of existing routinely collected clinical data for research purposes, whilst reducing NHS staff data collection burden.Wellbeing Software® provider of the Euroking® Maternity Information System, added new study specific data fields to their information system, extracted data from participating NHS sites and transferred data for matching with the National Neonatal Research Database to ascertain outcomes for babies admitted to neonatal units. Study set-up processes were put in place for all sites. The data extraction, linkage and cleaning processes were piloted with one pre-selected NHS site.ResultsTwenty-six NHS sites were set-up over 27 months (January 2019 - April 2021). Twenty-four thousand maternity records were extracted from the one NHS site, pertaining to the period January 2015 to March 2019. Data field completeness for maternal and neonatal primary outcomes were mostly acceptable. Neonatal identifiers flowed to the National Neonatal Research Database for successful matching and linkage between maternity and neonatal unit records.DiscussionPiloting the data extraction and linkage highlighted the need for additional governance arrangem
Smith ER, Oakley E, Grandner GW, et al., 2023, Adverse maternal, fetal, and newborn outcomes among pregnant women with SARS-CoV-2 infection: an individual participant data meta-analysis, BMJ Global Health, Vol: 8, Pages: 1-19, ISSN: 2059-7908
Introduction Despite a growing body of research on the risks of SARS-CoV-2 infection during pregnancy, there is continued controversy given heterogeneity in the quality and design of published studies.Methods We screened ongoing studies in our sequential, prospective meta-analysis. We pooled individual participant data to estimate the absolute and relative risk (RR) of adverse outcomes among pregnant women with SARS-CoV-2 infection, compared with confirmed negative pregnancies. We evaluated the risk of bias using a modified Newcastle-Ottawa Scale.Results We screened 137 studies and included 12 studies in 12 countries involving 13 136 pregnant women.Pregnant women with SARS-CoV-2 infection—as compared with uninfected pregnant women—were at significantly increased risk of maternal mortality (10 studies; n=1490; RR 7.68, 95% CI 1.70 to 34.61); admission to intensive care unit (8 studies; n=6660; RR 3.81, 95% CI 2.03 to 7.17); receiving mechanical ventilation (7 studies; n=4887; RR 15.23, 95% CI 4.32 to 53.71); receiving any critical care (7 studies; n=4735; RR 5.48, 95% CI 2.57 to 11.72); and being diagnosed with pneumonia (6 studies; n=4573; RR 23.46, 95% CI 3.03 to 181.39) and thromboembolic disease (8 studies; n=5146; RR 5.50, 95% CI 1.12 to 27.12).Neonates born to women with SARS-CoV-2 infection were more likely to be admitted to a neonatal care unit after birth (7 studies; n=7637; RR 1.86, 95% CI 1.12 to 3.08); be born preterm (7 studies; n=6233; RR 1.71, 95% CI 1.28 to 2.29) or moderately preterm (7 studies; n=6071; RR 2.92, 95% CI 1.88 to 4.54); and to be born low birth weight (12 studies; n=11 930; RR 1.19, 95% CI 1.02 to 1.40). Infection was not linked to stillbirth. Studies were generally at low or moderate risk of bias.Conclusions This analysis indicates that SARS-CoV-2 infection at any time during pregnancy increases the risk of maternal death, severe maternal morbidities and neonatal morbidity, but not stillbirth or intrauterine growth r
Mitchell EJ, Meakin G, Anderson J, et al., 2022, The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30–33 weeks gestational age), Trials, Vol: 23, Pages: 1-12, ISSN: 1745-6215
BackgroundIn the UK, approximately 8% of live births are preterm (before 37 weeks gestation), more than 90% of whom are born between 30 and 36 weeks, forming the largest proportion of a neonatal units’ workload. Neonatologists are cautious in initiating full milk feeds for preterm infants due to fears of necrotising enterocolitis (NEC). There is now evidence to dispute this fear. Small studies have shown that feeding preterm infants full milk feeds enterally from birth could result in a shorter length of hospital stay, which is important to parents, clinicians and NHS services without increasing the risk of NEC. This trial aims to investigate whether full milk feeds initiated in the first 24 h after birth reduces the length of hospital stay in comparison to introduction of gradual milk feeding with IV fluids or parenteral nutrition.MethodsFEED1 is a multi-centre, open, parallel group, randomised, controlled superiority trial of full milk feeds initiated on the day of birth versus gradual milk feeds for infants born at 30+0 to 32+6 (inclusive) weeks gestation. Recruitment will take place in around 40 UK neonatal units. Mothers will be randomised 1:1 to full milk feeds, starting at 60 ml/kg day, or gradual feeds, as per usual local practice. Mother’s expressed breast milk will always be the first choice of milk, though will likely be supplemented with formula or donor breast milk in the first few days. Feeding data will be collected until full milk feeds are achieved (≥ 140 ml/kg/day for 3 consecutive days). The primary outcome is length of infant hospital stay. Additional data will be collected 6 weeks post-discharge. Follow-up at 2 years (corrected gestational age) is planned. The sample size is 2088 infants to detect a between group difference in length of stay of 2 days. Accounting for multiple births, this requires 1700 women to be recruited. Primary analysis will compare the length of
Shen R, Embleton N, Forman J, et al., 2022, Early antibiotic use and incidence of necrotising enterocolitis in very preterm infants: a protocol for a UK based observational study using routinely recorded data, BMJ Open, Vol: 12, ISSN: 2044-6055
Introduction Necrotising enterocolitis (NEC) remains a major contributor to preterm mortality and morbidity. Prolonged duration of antibiotic therapy after delivery is associated with later NEC development but recent evidence suggests that absence of antibiotic treatment after delivery may also increase NEC risk. We will explore this controversy using a large pre-existing dataset of preterm infants in the UK.Methods and analysis: This is a retrospective cohort study using data from UK National Neonatal Research Database (NNRD) for infants born 1 January 2012 to 31 December 2020. Eligible infants will be <32 weeks gestation, alive on day 3. Primary outcome is development of severe NEC, compared in infants receiving early antibiotics (days 1–2 after birth) and those not. Subgroup analysis on duration of early antibiotic exposure will also occur. Secondary outcomes are: late onset sepsis, total antibiotic use, predischarge mortality, retinopathy of prematurity, intraventricular haemorrhage, bronchopulmonary dysplasia, focal intestinal perforation and any abdominal surgery. To address competing risks, incidence of death before day 7, 14 and 28 will be analysed. We will perform logistic regression and propensity score matched analyses. Statistical analyses will be guided by NEC risk factors, exposures and outcome presented in a causal diagram. These covariates include but are not limited to gestational age, birth weight, small for gestational age, sex, ethnicity, delivery mode, delivery without labour, Apgar score, early feeding and probiotic use. Sensitivity analyses of alternate NEC definitions, specific antibiotics and time of initiation will occur.Ethics and dissemination: We will use deidentified data from NNRD, which holds permissions for the original data, from which parents can opt out and seek study-specific research ethics approval. The results will help to determine optimal use of early antibiotics for very preterm infants.Implications: This data will
Rees P, Callan C, Chadda K, et al., 2022, Preterm brain injury and neurodevelopmental outcomes: a meta-analysis, Pediatrics, Vol: 150, Pages: 1-15, ISSN: 0031-4005
Context:Preterm brain injuries are common; neurodevelopmental outcomes following contemporary neonatal care are continually evolving.Objective:To systematically review and meta-analyze neurodevelopmental outcomes among preterm infants after intraventricular hemorrhage (IVH) and white matter injury (WMI). Data Sources:Published and grey literature were searched across 10 databases between 2000-2021Study Selection:Observational studies reporting 3-year neurodevelopmental outcomes for preterm infants with IVH or WMI compared to preterm infants without injury.Data extraction:Study characteristics, population characteristics, and outcome data were extracted.Results:38 studies were included. There was an increased adjusted risk of moderate-severe neurodevelopmental impairment after IVH grade 1-2 (aOR 1.35 [95% CI 1.05, 1.75]) and IVH grade 3-4 (aOR 4.26 [3.25, 5.59]). Children with IVH grade 1-2 had higher risks of cerebral palsy (OR 1.76 [1.39, 2.24)], cognitive (OR 1.79 [1.09, 2.95]), hearing (OR 1.83 CI [1.03. 3.24]), and visual impairment (OR 1.77 [1.08, 2.9]). Children with IVH grade 3-4 had markedly higher risks of cerebral palsy (OR 4.98 [4.13, 6.00)], motor (OR 2.7 [1.52, 4.8)], cognitive (OR 2.3 [1.67, 3.15)], hearing (OR 2.44 [1.42, 4.2)), and visual impairment (OR 5.42 [2.77, 10.58)). Children with WMI had much higher risks of cerebral palsy (OR 14.91 [7.3, 30.46), motor (OR 5.3 [3, 9.36)], and cognitive impairment (OR 3.48 [2.18, 5.53)).Limitations:Heterogeneity of outcome data.Conclusions:Mild IVH, severe IVH, and WMI are associated with adverse neurodevelopmental outcomes. Utilization of core outcomes sets and availability of open-access study data would improve our understanding of the nuances of these outcomes.
Yao S, Uthaya S, Gale C, et al., 2022, Postnatal corticosteroid use for prevention or treatment of Bronchopulmonary Dysplasia in England and Wales 2012-2019: a retrospective population cohort study, BMJ Open, Vol: 12, ISSN: 2044-6055
Objective: Describe the population of babies who do and do not receive postnatal corticosteroids for prevention or treatment of bronchopulmonary dysplasia (BPD).Design: Retrospective cohort study using data held in the National Neonatal Research Database.Setting: National Health Service neonatal units in England and Wales.Patients: Babies born less than 32 weeks gestation and admitted to neonatal units from 1 January 2012 to 31 December 2019.Main outcomes: Proportion of babies given postnatal corticosteroid; type of corticosteroid; age at initiation and duration, trends over time.Secondary outcomes: Survival to discharge, treatment for retinopathy of prematurity, BPD, brain injury, severe necrotising enterocolitis, gastrointestinal perforation.Results: 8% (4713/62019) of babies born <32 weeks and 26% (3525/13527) born <27 weeks received postnatal corticosteroids for BPD. Dexamethasone was predominantly used 5.3% (3309/62019), followed by late hydrocortisone 1.5%, inhaled budesonide 1.5%. prednisolone 0.8%, early hydrocortisone 0.3% and methylprednisolone 0.05%. Dexamethasone use increased over time (2012: 4.5 vs 2019: 5.8%, p=0.04). Median postnatal age of initiation of corticosteroid course was around 3 weeks for late hydrocortisone, 4 weeks for dexamethasone, 6 weeks for inhaled budesonide, 12 weeks for prednisolone and 16 weeks for methylprednisolone. Babies who received postnatal corticosteroids were born more prematurely, had a higher incidence of comorbidities and a longer length of stay.Conclusions: In England and Wales, around 1 in 12 babies born less than 32 weeks and 1 in 4 born less than 27 weeks receive postnatal corticosteroids to prevent or treat BPD. Given the lack of convincing evidence of efficacy, challenges of recruiting to and length of time taken to conduct randomised controlled trial, our data highlight the need to monitor long-term outcomes in children who received neonatal postnatal corticosteroids.
Harbottle V, Arnott B, Gale C, et al., 2022, Identifying common health indicators from paediatric core outcome sets: a systematic review with narrative synthesis using the WHO International Classification of Functioning, Health and Disability, BMJ Paediatrics Open, Vol: 6, Pages: 1-13, ISSN: 2399-9772
Background Indicators of child health have the potential to inform societal conversations, decision-making and prioritisation. Paediatric core outcome sets are an increasingly common way of identifying a minimum set of outcomes for trials within clinical groups. Exploring commonality across existing sets may give insight into universally important and inclusive child health indicators.Methods A search of the Core Outcome Measures in Effectiveness Trial register from 2008 to 2022 was carried out. Eligible articles were those reporting on core outcome sets focused on children and young people aged 0–18 years old. The International Classification of Functioning, Disability and Health (ICF) was used as a framework to categorise extracted outcomes. Information about the involvement of children, young people and their families in the development of sets was also extracted.Results 206 articles were identified, of which 36 were included. 441 unique outcomes were extracted, mapping to 22 outcome clusters present across multiple sets. Medical diagnostic outcomes were the biggest cluster, followed by pain, communication and social interaction, mobility, self-care and school. Children and young people’s views were under-represented across core outcome sets, with only 36% of reviewed studies including them at any stage of development.Conclusions Existing paediatric core outcome sets show overlap in key outcomes, suggesting the potential for generic child health measurement frameworks. It is unclear whether existing sets best reflect health dimensions important to children and young people, and there is a need for better child and young person involvement in health indicator development to address this.
Evans K, Battersby C, Boardman JP, et al., 2022, National priority setting partnership using a Delphi consensus process to develop neonatal research questions suitable for practice-changing randomised trials in the United Kingdom, BMJ Open, Vol: 12, Pages: 1-6, ISSN: 2044-6055
Introduction Methodologically robust clinical trials are required to improve neonatal care and reduce unwanted variations in practice. Previous neonatal research prioritisation processes have identified important research themes rather than specific research questions amenable to clinical trials. Practice-changing trials require well-defined research questions, commonly organised using the Population, Intervention, Comparison, Outcome (PICO) structure. By narrowing the scope of research priorities to those which can be answered in clinical trials and by involving a wide range of different stakeholders, we aim to provide a robust and transparent process to identify and prioritise research questions answerable within the National Healthcare System to inform future practice-changing clinical trials.Methods and analysis A steering group comprising parents, doctors, nurses, allied health professionals, researchers and representatives from key organisations (Neonatal Society, British Association of Perinatal Medicine, Neonatal Nurses Association and Royal College of Paediatrics and Child Health) was identified to oversee this project. We will invite submissions of research questions formatted using the PICO structure from the following stakeholder groups using an online questionnaire: parents, patients, healthcare professionals and academic researchers. Unanswered, non-duplicate research questions will be entered into a three-round eDelphi survey of all stakeholder groups. Research questions will be ranked by mean aggregate scores.Ethics and dissemination The final list of prioritised research questions will be disseminated through traditional academic channels, directly to key stakeholder groups through representative organisations and on social media. The outcome of the project will be shared with key research organisations such as the National Institute for Health Research. Research ethics committee approval is not required.
Woodward K, Cornish RP, Gale C, et al., 2022, Effect of SARS-CoV-2 infection in neonates or in pregnancy on developmental outcomes at 21-24 months (SINEPOST): study protocol for a prospective cohort study, BMJ Paediatrics Open, Vol: 6, Pages: 1-6, ISSN: 2399-9772
Introduction Exposure to SARS-CoV-2 during pregnancy or in the neonatal period may impact fetal or neonatal brain development either through direct central nervous system infection or indirectly through the adverse effects of viral infection-related inflammation in the mother or newborn infant. This study aims to determine whether there are early neurodevelopmental effects of SARS-CoV-2 infection.Methods and analysis We will conduct a prospective national population-based cohort study of children aged 21–24 months who were born at term (≥37 weeks’ gestation) between 1 March 2020 and 28 February 2021 and were either antenatally exposed, neonatally exposed or unexposed (comparison cohort) to SARS-CoV-2. Nationally, hospitals will identify and approach parents of children eligible for inclusion in the antenatally and neonatally exposed cohorts using information from the UK Obstetric Surveillance System (UKOSS) and British Paediatric Surveillance Unit (BPSU) national surveillance studies and will identify and approach eligible children for the comparison cohort through routine birth records. Parents will be asked to complete questionnaires to assess their child’s development at 21–24 months of age. Outcome measures comprise the Ages and Stages Questionnaire, Third Edition (ASQ-3), Ages and Stages Questionnaire Social-Emotional, Second Edition (ASQ-SE-2), Liverpool respiratory symptoms questionnaire and questionnaire items to elicit information about healthcare usage. With parental consent, study data will be linked to routine health and education records for future follow-up. Regression models will compare ASQ-3 and ASQ-SE-2 scores and proportions, frequency of respiratory symptoms and healthcare usage between the exposed and comparison cohorts, adjusting for potential confounders.Ethics and dissemination Ethics approval was obtained from the London-Westminster Research Ethics Committee. Findings will be disseminated in scientific conference p
Engjom HM, Ramakrishnan R, Vousden N, et al., 2022, Severity of maternal SARS-CoV-2 infection and perinatal outcomes of women admitted to hospital during the omicron variant dominant period using UK Obstetric Surveillance System data: prospective, national cohort study, BMJ Medicine, Vol: 1, ISSN: 2754-0413
OBJECTIVES: To describe the severity of maternal infection when the omicron SARS-CoV-2 variant (B.1.1.529) was dominant (15 December 2021 to 14 March 2022) and describe outcomes by symptoms and vaccination status. DESIGN: Prospective, national cohort study using the UK Obstetric Surveillance System. SETTING: 94 hospitals in the UK with a consultant led maternity unit. PARTICIPANTS: Pregnant women admitted to hospital for any cause with a positive SARS-CoV-2 test. MAIN OUTCOME MEASURES: Symptomatic or asymptomatic infection, vaccination status by doses before admission, and severity of maternal infection (moderate or severe infection according to modified World Health Organization's criteria). RESULTS: Of 3699 women who were admitted to hospital, 986 (26.7%, 95% confidence interval 25.3% to 28.1%) had symptoms; of these, 144 (14.6%, 12.5% to 17.0%) had a moderate to severe infection, 99 (10.4%, 8.6% to 12.5%) of 953 received respiratory support, and 30 (3.0%, 2.1% to 4.3%) were admitted to an intensive care unit. Covid-19 specific drug treatment was given to 13 (43.3%) of the 30 women in intensive care. Four women with symptoms died (0.4%, 0.1% to 1.1%). Vaccination status was known for 845 (85.6%) women with symptoms; 489 (58.9%) were unvaccinated and only 55 (6.5%) had three doses. Moderate to severe infection was reported for 93 (19.0%) of 489 unvaccinated women with symptoms, decreasing to three (5.5%) of 55 after three doses. Among the 30 women with symptoms who were admitted to intensive care, 23 (76.7%) were unvaccinated and none had received three doses. CONCLUSION: Most women with severe covid-19 disease were unvaccinated and vaccine coverage among pregnant women admitted to hospital with SARS-CoV-2 was low. Ongoing action to prioritise and advocate for vaccine uptake in pregnancy is essential. A better understanding of the persistent low use of drug treatments is an urgent priority. TRIAL REGISTRATION: ISRCTN 40092247.
Webbe J, Battersby C, Longford N, et al., 2022, Use of parenteral nutrition in the first postnatal week in England and Wales: An observational study using real-world data, BMJ Paediatrics Open, Vol: 6, ISSN: 2399-9772
BackgroundParenteral nutrition (PN) is used to provide supplemental support to neonates while enteral feeding is being established. PN is a high-cost intervention with beneficial and harmful effects. Internationally there is substantial variation in how PN is used, and there are limited contemporary data describing use across the UK. ObjectiveTo describe PN use in the first postnatal week in infants born and admitted to neonatal care in England, Scotland and Wales.MethodData describing neonates admitted to National Health Service (NHS) neonatal units between 1st January 2012 and 31st December 2017, extracted from routinely recorded data held the National Neonatal Research Database (NNRD); the denominator was live births, from Office for National Statistics.ResultsOver the study period 62,145 neonates were given PN in the first postnatal week (1.4% of all live births); use was higher in more preterm neonates (76% of livebirths at <28 weeks, 0.2% of term livebirths) and in neonates with lower birth weight. 15% (9181/62145) of neonates given PN in the first postnatal week were born at term. There was geographic variation in PN administration: the proportion of live births given PN within neonatal regional networks ranged from 1.0% (95% confidence intervals: 1.0, 1.0) to 2.8% (95% confidence interval: 2.7, 2.9). Conclusions and relevanceSignificant variation exists in neonatal PN use; it is unlikely this reflects optimal use of an expensive intervention. Research is needed to identify which babies will benefit most and which are at risk of harm from early PN. RegistrationClinicalTrials.gov: NCT03767634
Smith ER, Oakley E, He S, et al., 2022, Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods, PLoS One, Vol: 17, ISSN: 1932-6203
We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.
Vousden N, Ramakrishnan R, Bunch K, et al., 2022, Severity of maternal infection and perinatal outcomes during periods of SARS-CoV-2 wildtype, alpha, and delta variant dominance in the UK: prospective cohort study, BMJ Medicine, Vol: 1, ISSN: 2754-0413
OBJECTIVE: To compare the severity of maternal infection and perinatal outcomes during periods in which wildtype, alpha variant, and delta variant of SARS-CoV-2 were dominant in the UK. DESIGN: Prospective cohort study. SETTING: 194 obstetric units across the UK, during the following periods: between 1 March and 30 November 2020 (wildtype dominance), between 1 December 2020 and 15 May 2021 (alpha variant dominance), and between 16 May and 31 October 2021 (delta variant dominance). PARTICIPANTS: 4436 pregnant women admitted to hospital with covid-19 related symptoms. MAIN OUTCOME MEASURES: Moderate to severe maternal SARS-CoV-2 infection (indicated by any of the following: oxygen saturation <95% on admission, need for oxygen treatment, evidence of pneumonia on imaging, admission to intensive care, or maternal death), and pregnancy and perinatal outcomes (including mode and gestation of birth, stillbirth, live birth, admission to neonatal intensive care, and neonatal death). RESULTS: 1387, 1613, and 1436 pregnant women were admitted to hospital with covid-19 related symptoms during the wildtype, alpha, and delta dominance periods, respectively; of these women, 340, 585, and 614 had moderate to severe infection, respectively. The proportion of pregnant women admitted with moderate to severe infection increased during the subsequent alpha and delta dominance periods, compared with the wildtype dominance period (wildtype 24.5% v alpha 36.2% (adjusted odds ratio 1.98, 95% confidence interval 1.66% to 2.37%); wildtype 24.5% v delta 42.8% (2.66, 2.21 to 3.20)). Compared with the wildtype dominance period, women admitted during the alpha dominance period were significantly more likely to have pneumonia, require respiratory support, and be admitted to intensive care; these three risks were even greater during the delta dominance period (wildtype v delta: pneumonia, adjusted odds ratio 2.52, 95% confidence interval 2.06 to 3.09; respiratory support, 1.90, 1.52 to 2.3
Greenbury SF, Angelini DE, Ougham K, et al., 2022, Post-natal growth of very preterm neonates, The Lancet Child & Adolescent Health, Vol: 6, Pages: E11-E11, ISSN: 2352-4642
Vousden N, Ramakrishnan R, Bunch K, et al., 2022, Management and implications of severe COVID-19 in pregnancy in the UK: data from the UK Obstetric Surveillance System national cohort, Acta Obstetricia et Gynecologica Scandinavica, Vol: 101, ISSN: 0001-6349
INTRODUCTION: There is a lack of population level data on risk factors and impact of severe COVID-19 in pregnancy. The aims of this study were to determine the characteristics, and maternal and perinatal outcomes associated with severe COVID-19 in pregnancy compared with those with mild and moderate COVID-19 and to explore the impact of timing of birth. MATERIAL AND METHODS: This was a secondary analysis of a national, prospective cohort study. All pregnant women admitted to hospital in the UK with symptomatic SARS-CoV-2 from March 1, 2020 to October 31, 2021 were included. The severity of maternal infection (need for high flow or invasive ventilation, intensive care admission or died), pregnancy and perinatal outcomes, and the impact of timing of birth were analyzed using multivariable logistic regression. RESULTS: Of 4436 pregnant women, 13.9% (n = 616) had severe infection. Women with severe infection were more likely to be aged ≥30 years (adjusted odds ratio [aOR] aged 30-39 1.48, 95% confidence interval [CI] 1.20-1.83), be overweight or obese (aOR 1.73, 95% CI 1.34-2.25 and aOR 2.52 95% CI 1.97-3.23, respectively), be of mixed ethnicity (aOR 1.93, 95% CI 1.17-3.21) or have gestational diabetes (aOR 1.43, 95% CI 1.09-1.87) compared with those with mild or moderate infection. Women with severe infection were more likely to have a pre-labor cesarean birth (aOR 8.84, 95% CI 6.61-11.83), a very or extreme preterm birth (28-31+ weeks' gestation, aOR 18.97, 95% CI 7.78-14.85; <28 weeks' gestation, aOR 12.35, 95% CI 6.34-24.05) and their babies were more likely to be stillborn (aOR 2.51, 95% CI 1.35-4.66) or admitted to a neonatal unit (aOR 11.61, 95% CI 9.28-14.52). Of 112 women with severe infection who were discharged and gave birth at a later admission, the majority gave birth ≥36 weeks (85.7%), noting that three women in this group (2.7%) had a stillbirth. CONCLUSIONS: Severe COVID-19 in pregnancy increases the risk of advers
Webbe J, Longford N, Battersby C, et al., 2022, Outcomes in relation to early parenteral nutrition use in preterm neonates born between 30 and 33 weeks gestation: a propensity score matched observational study, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 107, Pages: 131-136, ISSN: 1359-2998
ObjectiveTo evaluate whether in preterm neonates parenteral nutrition use in the first sevenpostnatal days, compared with no parenteral nutrition use, is associated withdifferences in survival and other important morbidities. Randomised trials in criticallyill older children show that harms, such as nosocomial infection, outweigh benefits ofearly parenteral nutrition administration; there is a paucity of similar data inneonates.DesignRetrospective cohort study using propensity matching including 35 maternal, infantand organisational factors to minimise bias and confounding.SettingNational, population-level clinical data obtained for all National Health Serviceneonatal units in England and Wales.PatientsPreterm neonates born between 30+0 and 32+6 weeks+days.InterventionsThe exposure was parenteral nutrition administered in the first seven days ofpostnatal life; the comparator was no parenteral nutrition.Main outcome measuresThe primary outcome was survival to discharge from neonatal care. Secondaryoutcomes comprised the neonatal core outcome set.Results16,292 neonates were compared in propensity score matched analyses. Comparedwith matched neonates not given parenteral nutrition in the first postnatal week, neonates who received parenteral nutrition had higher survival at discharge(absolute rate increase 0.91%; 95% CI 0.53% to 1.30%), but higher rates ofnecrotising enterocolitis (absolute rate increase 4.6%), bronchopulmonary dysplasia(absolute rate increase 3.9%), late-onset sepsis (absolute rate increase 1.5%) andneed for surgical procedures (absolute rate increase 0.92%).ConclusionsIn neonates born between 30+0 and 32+6 weeks gestation, those given parenteralnutrition in the first postnatal week had a higher rate of survival but higher rates ofimportant neonatal morbidities. Clinician equipoise in this area should be resolvedby prospective, randomised trials.
Li Y, kurinczuk JJ, Gale C, et al., 2022, Evidence of disparities in the provision of the maternal postpartum six week check in primary care in England, 2015- 2018: an observational study using the Clinical Practice Research Datalink (CPRD), Journal of Epidemiology and Community Health, Vol: 76, Pages: 239-246, ISSN: 0143-005X
Background A maternal postpartum six-week check (SWC) with a General Practitioner (GP) is now considered an essential service in England, a recent policy change intended to improve women’s health. We aimed to provide an up-to-date snapshot of the prevalence of SWC prior to the policy change as a baseline, and to explore factors associated with having a late or no check. Methods We conducted a cohort study using primary care records in England (Clinical Practice Research Datalink (CPRD)). 34,337 women who gave birth between 1st July 2015 and 30th June 2018 and had ≥12 weeks of follow-up postpartum, were identified in the CPRD Pregnancy Register. The proportion who had evidence of a SWC with a GP was calculated, and regression analysis was used to assess the association between women’s characteristics and risks of a late or no check.Results Sixty-two percent (95%CI: 58%-67%) of women had a SWC recorded at their GP practice within 12 weeks postpartum, another 27% had other consultations. Forty percent had a SWC at the recommended 6-8 weeks, 2% earlier and 20% later. A late or no check was more common among younger women, mothers of preterm babies, or those registered in more deprived areas.Conclusions Nearly 40% of women did not have a postpartum SWC recorded. Provision or uptake was not equitable; younger women and those in more deprived areas were less likely to have a record of such check, suggesting postpartum care in general practice may be missing some women who need it most.
Henry CJ, Semova G, Barnes E, et al., 2022, Neonatal sepsis: a systematic review of core outcomes from randomised clinical trials, Pediatric Research, Vol: 91, ISSN: 0031-3998
BACKGROUND: The lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice relevant to key stakeholders, patients and parents. METHODS: A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In the included studies, the described outcomes were extracted in accordance with the provisions of the Core Outcome Measures in Effectiveness Trials (COMET) handbook and registered. RESULTS: Among 884 abstracts identified, 90 randomised controlled trials (RCTs) were included in this review. Only 30 manuscripts explicitly stated the primary and/or secondary outcomes. A total of 88 distinct outcomes were recorded across all 90 studies included. These were then assigned to seven different domains in line with the taxonomy for classification proposed by the COMET initiative. The most frequently reported outcome was survival with 74% (n = 67) of the studies reporting an outcome within this domain. CONCLUSIONS: This systematic review constitutes one of the initial phases in the protocol for developing a COS in neonatal sepsis. The paucity of standardised outcome reporting in neonatal sepsis hinders comparison and synthesis of data. The final phase will involve a Delphi Survey to generate a COS in neonatal sepsis by consensus recommendation. IMPACT: This systematic review identified a wide variation of outcomes reported among published RCTs on the management of neonatal sepsis. The paucity of standardised outcome reporting hinders comparison and synthesis of data and future meta-analyses with conclusive recommendations on the management of neonatal sepsis are unlikely. The final phase will involve a Delphi Survey to determine a COS by consensus recommendation with input from all relevant stakeholders.
Malouf R, Harrison S, Burton HAL, et al., 2022, Prevalence of anxiety and post-traumatic stress (PTS) among the parents of babies admitted to neonatal units: a systematic review and meta-analysis, EClinicalMedicine, Vol: 43, ISSN: 2589-5370
BackgroundParents of babies admitted to neonatal units (NNU) are exposed to a range of potentially distressing experiences, which can lead to mental health symptoms such as increased anxiety and post-traumatic stress (PTS). This review aimed to describe how anxiety and PTS are defined and assessed, and to estimate anxiety and PTS prevalence among parents of babies admitted to NNU.MethodMedline, Embase, PsychoINFO, Cumulative Index to Nursing and Allied Health literature were searched to identify studies published prior to April 14, 2021. Included studies were assessed using Hoy risk of bias tool. A random-effects model was used to estimate pooled prevalence with 95% CIs. Potential sources of variation were investigated using subgroup analyses and meta-regression. The review is registered with PROSPERO (CRD42020162935).FindingsFifty six studies involving 6,036 parents met the review criteria; 21 studies assessed anxiety, 35 assessed PTS, and 8 assessed both. The pooled prevalence of anxiety was 41.9% (95%CI:30.9, 53.0) and the pooled prevalence of PTS was 39.9% (95%CI:30.8, 48.9) among parents up to one month after the birth. Anxiety prevalence decreased to 26.3% (95%CI:10.1, 42.5) and PTS prevalence to 24.5% (95%CI:17.4, 31.6) between one month and one year after birth. More than one year after birth PTS prevalence remained high 27.1% (95%CI:20.7, 33.6). Data on anxiety at this time point were limited. There was high heterogeneity between studies and some evidence from subgroup and meta-regression analyses that study characteristics contributed to the variation in prevalence estimates.InterpretationThe prevalence of anxiety and PTS was high among parents of babies admitted to NNU. The rates declined over time, although they remained higher than population prevalence estimates for women in the perinatal period. Implementing routine screening would enable early diagnosis and effective intervention.FundingThis research is funded by the National Institute for Health Res
Mc Cord K, Imran M, Rice DB, et al., 2022, Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results, Journal of Clinical Epidemiology, Vol: 141, Pages: 175-186, ISSN: 0895-4356
Objective: Registries are important data sources for randomised controlled trials (RCTs), butreporting of how they are used may be inadequate. The objective was to describe the currentadequacy of reporting of RCTs using registries.Study Design and Setting: We used a database of trials using registries from a scopingreview supporting the development of the 2021 CONSORT extension for Trials ConductedUsing Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reportingcompleteness of 13 CONSORT-ROUTINE items was assessed.Results: We assessed reports of 47 RCTs that used a registry, published between 2011 and2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half ofreports (2 in at least 80%). The 7 other items were related to routinely collected data sourceeligibility (32% adequate), data linkage (8% adequate), validation and completeness of dataused for outcome assessment (8% adequate), validation and completeness of data used forparticipant recruitment (0% adequate), participant flow (9% adequate), registry funding (6%adequate) and interpretation of results in consideration of registry use (25% adequate).Conclusion: Reporting of trials using registries was often poor, particularly details on datalinkage and quality. Better reporting is needed for appropriate interpretation of the results ofthese trials.Keywords: registries, CONSORT, CONSORT-ROUTINE, randomised controlled trials,reporting guideline, routinely collected dataRunning Title: Completeness and Transparency of Reporting of RCTs using Registries
McCall SJ, Imran M, Hemkens LG, et al., 2022, Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement, Journal of Clinical Epidemiology, Vol: 141, Pages: 198-209, ISSN: 0895-4356
Objective:To describe characteristics of randomized controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.Study Design:MEDLINE and Cochrane Methodology Register were searched for a sample of RCTs published from 2011–2018. Completeness of reporting was assessed in a random sample using a pre-defined coding form.Results:Of the 183 RCT publications identified, 122 (67%) used EHRs to identify eligible participants, 139 (76%) used the EHR as part of the intervention and 137 (75%) to ascertain outcomes. When 60 publications were evaluated against the CONSORT 2010 item and the corresponding extension for the 8 modified items, four items were 'adequately reported' for most trials. Five new reporting items were identified for the CONSORT-ROUTINE extension; when evaluated, one was ‘adequately reported’, three were reported ‘inadequately or not at all’, the other ‘partially’. There were, however, some encouraging signs with adequate and partial reporting of many important items, including descriptions of trial design, the consent process, outcome ascertainment and interpretation.Conclusion:Aspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting.
Imran M, McCord K, McCall SJ, et al., 2022, Reporting transparency and completeness in trials: Paper 3 - trials conducted using administrative databases do not adequately report elements related to use of databases, Journal of Clinical Epidemiology, Vol: 141, Pages: 187-197, ISSN: 0895-4356
Objective: We evaluated reporting completeness and transparency in randomised controlled trials (RCTs) conducted using administrative data based on 2021 CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.Study Design and Setting: MEDLINE and the Cochrane Methodology Register were searched (2011 and 2018). Eligible RCTs used administrative databases for identifying eligible participants or collecting outcomes. We evaluated reporting based on CONSORT-ROUTINE, which modified eight items from CONSORT 2010 and added five new items.Results: Of 33 included trials (76% used administrative databases for outcomes, 3% for identifying participants, 21% both), most were conducted in the United States (55%), Canada (18%), or the United Kingdom (12%). Of eight items modified in the extension; six were adequately reported in a majority (>50%) of trials. For the CONSORT-ROUTINE modification portion of those items, three items were reported adequately in >50% of trials, two in <50%, two only applied to some trials, and one only had wording modifications and was not evaluated. For five new items, four that address use of routine data in trials were reported inadequately in most trials. Conclusion: How administrative data are used in trials is often sub-optimally reported. CONSORT-ROUTINE uptake may improve reporting.
Shipley L, Mistry A, Sharkey D, 2022, Outcomes of neonatal hypoxic-ischaemic encephalopathy in centres with and without active therapeutic hypothermia: a nationwide propensity score-matched analysis., Arch Dis Child Fetal Neonatal Ed, Vol: 107, Pages: 6-12
OBJECTIVE: Therapeutic hypothermia (TH) for neonatal hypoxic-ischaemic encephalopathy (HIE), delivered mainly in tertiary cooling centres (CCs), reduces mortality and neurodisability. It is unknown if birth in a non-cooling centre (non-CC), without active TH, impacts short-term outcomes. DESIGN: Retrospective cohort study using National Neonatal Research Database and propensity score-matching. SETTING: UK neonatal units. PATIENTS: Infants ≥36 weeks gestational age with moderate or severe HIE admitted 2011-2016. INTERVENTIONS: Birth in non-CC compared with CC. MAIN OUTCOME MEASURES: Primary outcome was survival to discharge without recorded seizures. Secondary outcomes were recorded seizures, mortality and temperature on arrival at CCs following transfer. RESULTS: 5059 infants were included with 2364 (46.7%) born in non-CCs. Birth in a CC was associated with improved survival without seizures (35.1% vs 31.8%; OR 1.15, 95% CI 1.02 to 1.31; p=0.02), fewer seizures (60.7% vs 64.6%; OR 0.84, 95% CI 0.75 to 0.95, p=0.007) and similar mortality (15.8% vs 14.4%; OR 1.11, 95% CI 0.93 to 1.31, p=0.20) compared with birth in a non-CC. Matched infants from level 2 centres only had similar results, and birth in CCs was associated with greater seizure-free survival compared with non-CCs. Following transfer from a non-CC to a CC (n=2027), 1362 (67.1%) infants arrived with a recorded optimal therapeutic temperature but only 259 (12.7%) of these arrived within 6 hours of birth. CONCLUSIONS: Almost half of UK infants with HIE were born in a non-CC, which was associated with suboptimal hypothermic treatment and reduced seizure-free survival. Provision of active TH in non-CC hospitals prior to upward transfer warrants consideration.
Ryan L, Ploetz FB, van den Hoogen A, et al., 2021, Neonates and COVID-19: state of the art Neonatal Sepsis series, Pediatric Research, Vol: 91, Pages: 432-439, ISSN: 0031-3998
The SARS-CoV-2 pandemic has had a significant impact worldwide, particularly in middle- and low-income countries. While this impact has been well-recognized in certain age groups, the effects, both direct and indirect, on the neonatal population remain largely unknown. There are placental changes associated, though the contributions to maternal and fetal illness have not been fully determined. The rate of premature delivery has increased and SARS-CoV-2 infection is proportionately higher in premature neonates, which appears to be related to premature delivery for maternal reasons rather than an increase in spontaneous preterm labor. There is much room for expansion, including long-term data on outcomes for affected babies. Though uncommon, there has been evidence of adverse events in neonates, including Multisystem Inflammatory Syndrome in Children, associated with COVID-19 (MIS-C). There are recommendations for reduction of viral transmission to neonates, though more research is required to determine the role of passive immunization of the fetus via maternal vaccination. There is now considerable evidence suggesting that the severe visitation restrictions implemented early in the pandemic have negatively impacted the care of the neonate and the experiences of both parents and healthcare professionals alike. Ongoing collaboration is required to determine the full impact, and guidelines for future management.
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