60 results found
Ashworth D, Battersby C, Bick D, et al., 2023, A treatment strategy with nifedipine versus labetalol for women with pregnancy hypertension: study protocol for a randomised controlled trial (Giant PANDA), Trials, Vol: 24, Pages: 1-14, ISSN: 1745-6215
BACKGROUND: Approximately one in ten women have high blood pressure during pregnancy. Hypertension is associated with adverse maternal and perinatal outcomes, and as treatment improves maternal outcomes, antihypertensive treatment is recommended. Previous trials have been unable to provide a definitive answer on which antihypertensive treatment is associated with optimal maternal and neonatal outcomes and the need for robust evidence evaluating maternal and infant benefits and risks remains an important, unanswered question for research and clinical communities. METHODS: The Giant PANDA study is a pragmatic, open-label, multicentre, randomised controlled trial of a treatment initiation strategy with nifedipine (calcium channel blocker), versus labetalol (mixed alpha/beta blocker) in 2300 women with pregnancy hypertension. The primary objective is to evaluate if treatment with nifedipine compared to labetalol in women with pregnancy hypertension reduces severe maternal hypertension without increasing fetal or neonatal death or neonatal unit admission. Subgroup analyses will be undertaken by hypertension type (chronic, gestational, pre-eclampsia), diabetes (yes, no), singleton (yes, no), self-reported ethnicity (Black, all other), and gestational age at randomisation categories (11 + 0 to 19 + 6, 20 + 0 to 27 + 6, 28 + 0 to 34 + 6 weeks). A cost-effectiveness analysis using an NHS perspective will be undertaken using a cost-consequence analysis up to postnatal hospital discharge and an extrapolation exercise with a lifetime horizon conditional on the results of the cost-consequence analysis. DISCUSSION: This trial aims to address the uncertainty of which antihypertensive treatment is associated with optimal maternal and neonatal outcomes. The trial results are intended to provide definitive evidence to inform guidelines and linked, shared decision-making tools, thus influencing cl
Venkatesan T, Rees P, Gardiner J, et al., 2023, National trends in preterm infant mortality in the United States by race and socioeconomic status, 1995-2020, JAMA Pediatrics, ISSN: 1072-4710
Importance Inequalities in preterm infant mortality exist between population subgroups within the United States.Objective To characterize trends in preterm infant mortality by maternal race and socioeconomic status to assess how inequalities in preterm mortality rates have changed over time.Design, Setting, and Participants This was a retrospective longitudinal descriptive study using the US National Center for Health Statistics birth infant/death data set for 12 256 303 preterm infant births over 26 years, between 1995 and 2020. Data were analyzed from December 2022 to March 2023.Exposures Maternal characteristics including race, smoking status, educational attainment, antenatal care, and insurance status were used as reported on an infant’s US birth certificate.Main Outcomes and Measures Preterm infant mortality rate was calculated for each year from 1995 to 2020 for all subgroups, with a trend regression coefficient calculated to describe the rate of change in preterm mortality.Results The average US preterm infant mortality rate (IMR) decreased from 33.71 (95% CI, 33.71 to 34.04) per 1000 preterm births per year between 1995-1997, to 23.32 (95% CI, 23.05 to 23.58) between 2018-2020. Black non-Hispanic infants were more likely to die following preterm births than White non-Hispanic infants (IMR, 31.09; 95% CI, 30.44 to 31.74, vs 21.81; 95% CI, 21.43 to 22.18, in 2018-2020); however, once born, extremely prematurely Black and Hispanic infants had a narrow survival advantage (IMR rate ratio, 0.87; 95% CI, 0.84 to 0.91, in 2018-2020). The rate of decrease in preterm IMR was higher in Black infants (−0.015) than in White (−0.013) and Hispanic infants (−0.010); however, the relative risk of preterm IMR among Black infants compared with White infants remained the same between 1995-1997 vs 2018-2020 (relative risk, 1.40; 95% CI, 1.38 to 1.44, vs 1.43; 95% CI, 1.39 to 1.46). The rate of decrease in preterm IMR was higher in nonsmokers compar
Harnden F, Lanoue J, Modi N, et al., 2023, A data-driven approach to understanding neonatal palliative care needs in England and Wales: a population based study 2015-2020, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 108, Pages: 540-544, ISSN: 1359-2998
ObjectiveTo quantify admissions to neonatal units in England and Wales with potential need for palliative care. Design, setting, and patientsDiagnoses and clinical attributes indicating a high likelihood of requiring palliative care were mapped to categories within the British Association of Perinatal Medicine’s (BAPM) framework on palliative care. We extracted data from the National Neonatal Research Database on all babies born and admitted to neonatal units in England and Wales 2015-2020.OutcomesThe number and proportion of babies meeting BAPM categories, their discharge outcomes, and the characteristics of babies who died during neonatal care but did not fulfil any BAPM category.Results12,123/574,954 (2.1%) babies met one or more BAPM category: 6,239/12,123 (51%) conformed to BAPM category 4 (postnatal conditions with high risk of severe impairment), 3,796 (31%) to category 2 (antenatal/postnatal diagnosis with high risk of significant morbidity or death), 1,399 (12%) to category 3 (born at margin of viability), and 288 (2%) to category 1 (antenatal/postnatal diagnosis not compatible with long-term survival); 401 babies (3%) met criteria for multiple categories. 6,814/12,123 (56%) were discharged home, 2,385 (20%) were discharged to other settings and 2,914 (24%) died before neonatal discharge. 3,000/5,914 (51%) babies who died during neonatal care did not conform to any BAPM category. Of these, 2,630/3,000 (88%) were born preterm.ConclusionsAt least 2% of babies admitted to neonatal units had palliative care needs according to existing BAPM categories; most survived to discharge. Of deaths, 51% were not captured by the BAPM categories; most were extremely preterm.
Smith L, van Blankenstein E, Fox G, et al., 2023, Impact of new national guidance on survival for babies born at 22-weeks’ gestation in England and Wales: a population-based cohort, BMJ Medicine, ISSN: 2754-0413
van Blankenstein E, Sodiwala T, Lanoue J, et al., 2023, Two-year neurodevelopmental data for preterm infants born over an 11-year period in England and Wales, 2008-2018: a retrospective study using the National Neonatal Research Database, Archives of Disease in Childhood: Fetal and Neonatal Edition, ISSN: 1359-2998
Piyasena C, Galu S, Yoshida R, et al., 2023, Comparison of diagnoses of early onset sepsis associated with use of Sepsis Risk Calculator versus NICE CG149: a prospective, population-wide cohort study in London, UK, 2020-21, BMJ Open, Vol: 13, Pages: 1-8, ISSN: 2044-6055
Objective: We sought to compare the incidence of early-onset sepsis (EOS) in infants ≥34 weeks’ gestation identified > 24 hours after birth, in hospitals using the Kaiser Permanente sepsis risk calculator (SRC) with hospitals using the NICE guidance.Design and setting: Prospective observational population-wide cohort study involving all 26 hospitals with neonatal units co-located with maternity services across London (10 using SRC, 16 using NICE). Participants: All livebirths ≥34 weeks’ gestation between September 2020 and August 2021. Outcome measures: EOS was defined as isolation of a bacterial pathogen in the blood or CSF culture from birth to 7 days of age. We evaluated the incidence of EOS identified by culture obtained >24 hours to 7 days after birth. We also evaluated the rate empiric antibiotics were commenced >24 hours to 7 days after birth, for a duration of ≥5 days, with negative blood or CSF cultures. Results: Of 99,683 livebirths, 42,952 (43%) were born in SRC hospitals and 56,731 (57%) in NICE hospitals. The overall incidence of EOS (<72 hours) was 0·64/1000 livebirths. The incidence of EOS identified >24 hours was 2.3/100,000 (n=1) for SRC versus 7.1/100,000 (n=4) for NICE (odds ratio 0·5, 95%CI [0·1; 2·7]). This corresponded to (1/20) 5% (SRC) versus (4/45) 8.9% (NICE) of EOS cases (chi=0.3, p=0.59). Empiric antibiotics were commenced >24 hours to 7 days after birth in 4·4/1000 (n=187) for SRC versus 2·9/1000 (n=158) for NICE (odds ratio 1·5, 95%CI [1·2; 1·9]). 3111 (7%) infants received antibiotics in the first 24 hours in SRC hospitals versus 8428 (15%) in NICE hospitals. Conclusion: There was no significant difference in the incidence of EOS identified >24 hours after birth between SRC and NICE hospitals. SRC use was associated with 50% fewer infants receiving antibiotics in the first 24 hours of life.
Rees P, Callan C, Chadda KR, et al., 2023, Childhood outcomes after low-grade Intraventricular Haemorrhage: a systematic review and meta-analysis, Developmental Medicine and Child Neurology, ISSN: 0012-1622
AimTo undertake a systematic review and meta-analysis exploring school-aged neurodevelopmental outcomes of children after low-grade intraventricular haemorrhage (IVH).MethodsThe published and grey literature was extensively searched to identify observational comparative studies exploring neurodevelopmental outcomes after IVH grade 1-2. Our primary outcome was neurodevelopmental impairment after 5 years of age, which included cognitive, motor, speech and language, behavioural, hearing or visual impairments.ResultsThis review included 12 studies and over 2,036 preterm infants with low grade IVH. Studies used 30 different neurodevelopmental tools to determine outcomes. There was conflicting evidence of the composite risk of neurodevelopmental impairment after low-grade IVH. There was evidence of an association between low-grade IVH and lower IQ at school age -4.23 95% CI (-7.53, -0.92) I2=0% but impact on school performance was unclear. Studies reported an increased crude risk of cerebral palsy after low-grade IVH OR 2.92 95%CI (1.95, 4.37) I2=41%. No increased risk of speech and language impairment or behavioural impairment was found. Few studies addressed hearing and visual impairment.InterpretationThis review presents evidence that low-grade IVH is associated with specific neurodevelopmental impairments at school age, lending support to the theory that low-grade IVH is not a benign condition.
Nezafat Maldonado B, Singhal G, Chow LY, et al., 2023, Association between birth location and short-term outcomes for babies with gastroschisis, congenital diaphragmatic hernia and oesophageal fistula: a systematic review, BMJ Paediatrics Open, Vol: 7, Pages: 1-14, ISSN: 2399-9772
Background Neonatal care is commonly regionalised, meaning specialist services are only available at certain units. Consequently, infants with surgical conditions needing specialist care who are born in non-surgical centres require postnatal transfer. Best practice models advocate for colocated maternity and surgical services as the place of birth for infants with antenatally diagnosed congenital conditions to avoid postnatal transfers. We conducted a systematic review to explore the association between location of birth and short-term outcomes of babies with gastroschisis, congenital diaphragmatic hernia (CDH) and oesophageal atresia with or without tracheo-oesophageal fistula (TOF/OA).Methods We searched MEDLINE, CINAHL, Web of Science and SCOPUS databases for studies from high income countries comparing outcomes for infants with gastroschisis, CDH or TOF/OA based on their place of delivery. Outcomes of interest included mortality, length of stay, age at first feed, comorbidities and duration of parenteral nutrition. We assessed study quality using the Newcastle-Ottawa Scale. We present a narrative synthesis of our findings.Results Nineteen cohort studies compared outcomes of babies with one of gastroschisis, CDH or TOF/OA. Heterogeneity across the studies precluded meta-analysis. Eight studies carried out case-mix adjustments. Overall, we found conflicting evidence. There is limited evidence to suggest that birth in a maternity unit with a colocated surgical centre was associated with a reduction in mortality for CDH and decreased length of stay for gastroschisis.Conclusions There is little evidence to suggest that delivery in colocated maternity-surgical services may be associated with shortened length of stay and reduced mortality. Our findings are limited by significant heterogeneity, potential for bias and paucity of strong evidence. This supports the need for further research to investigate the impact of birth location on outcomes for babies with congenital
Patel N, NeoTRIPs CG, Evans K, et al., 2023, How frequent is routine use of probiotics in UK Neonatal Units?, BMJ Paediatrics Open, Vol: 7, Pages: 1-6, ISSN: 2399-9772
Objective: There is a lack of UK guidance regarding routine use of probiotics in preterm infants to prevent necrotising enterocolitis, late-onset sepsis, and death. As practices can vary, we aimed to determine the current usage of probiotics within neonatal units in the United Kingdom.Design and setting: Using NeoTRIPS, a trainee-led neonatal research network, an online survey was disseminated to neonatal units of all service levels within England, Scotland, Northern Ireland, and Wales in 2022. Trainees were requested to complete one survey per unit regarding routine probiotic administration. Results: 161/188 (86%) neonatal units responded to the survey. 70/161 (44%) respondents routinely give probiotics to preterm infants. 45/70 (64%) use the probiotic product Lactobacillus acidophilus NCFM/Bifidobacterium bifidum Bb-06/Bifidobacterium infantis Bi-26 (Labinic™). 57/70 (81%) start probiotics in infants ≤32 weeks gestation. 33/70 (47%) had microbiology departments that were aware of the use of probiotics and 64/70 (91%) had a guideline available. Commencing enteral feeds was a prerequisite to starting probiotics in 62/70 (89%) units. The majority would stop probiotics if enteral feeds were withheld (59/70; 84%) or if the infant was being treated for necrotising enterocolitis (69/70; 99%). 24/91 (26%) units that did not use probiotics at the time of the survey were planning to introduce them within the next 12 months. Conclusion: More than 40% of all UK neonatal units that responded are now routinely administering probiotics, with variability in the product used. With increased probiotic usage in recent years, there is a need to establish whether this translates to improved clinical outcomes.
Modi N, Ribas R, Johnson S, et al., 2023, Pilot feasibility study of a digital technology approach to the systematic electronic capture of parent-reported data on cognitive and language development in children aged 2 years, BMJ Health & Care Informatics, Vol: 30, Pages: 1-5, ISSN: 2632-1009
Background The assessment of language and cognition in children at risk of impaired neurodevelopment following neonatal care is a UK standard of care but there is no national, systematic approach for obtaining these data. To overcome these challenges, we developed and evaluated a digital version of a validated parent questionnaire to assess cognitive and language development at age 2 years, the Parent Report of Children’s Abilities-Revised (PARCA-R).Methods We involved clinicians and parents of babies born very preterm who received care in north-west London neonatal units. We developed a digital version of the PARCA-R questionnaire using standard software. Following informed consent, parents received automated notifications and an invitation to complete the questionnaire on a mobile phone, tablet or computer when their child approached the appropriate age window. Parents could save and print a copy of the results. We evaluated ease of use, parent acceptability, consent for data sharing through integration into a research database and making results available to the clinical team.Results Clinical staff approached the parents of 41 infants; 38 completed the e-registration form and 30 signed the e-consent. The digital version of the PARCA-R was completed by the parents of 21 of 23 children who reached the appropriate age window. Clinicians and parents found the system easy to use. Only one parent declined permission to integrate data into the National Neonatal Research Database for approved secondary purposes.Discussion This electronic data collection system and associated automated processes enabled efficient systematic capture of data on language and cognitive development in high-risk children, suitable for national delivery at scale.
Conti-Ramsden F, Fleminger J, Lanoue J, et al., 2023, The contribution of hypertensive disorders of pregnancy to late preterm and term admissions to neonatal units in the UK 2012-2020 and opportunities to avoid admission: a population-based study using the National Neonatal Research Database, British journal of obstetrics and gynaecology, ISSN: 0306-5456
Objective: To quantify maternal hypertensive disorder of pregnancy (HDP) prevalence in late preterm and term infants admitted to neonatal units (NNU) and assess opportunities to avoid admissions.Design: A retrospective population-based study using the National Neonatal Research Database.Setting: England and Wales. Population: Infants born ≥ 34 weeks’ gestation admitted to NNU between 2012 and 2020. Methods: Outcomes in HDP infants are compared to non-HDP infants using regression models. Main outcomes measures: HDP, primary reason for admission, clinical diagnoses and resource use.Results: 16,059/136,220 (11.8%) of late preterm (34+0-36+6 weeks’ gestation) and 14,885/284,646 (5.2%) of term (≥ 37 weeks’ gestation) admitted infants were exposed to maternal HDP. The most common primary reasons for HDP infant admission were respiratory disease (28.3%), prematurity (22.7%) and hypoglycaemia (16.4%). HDP infants were more likely to be admitted with primary hypoglycaemia than non-HDP infants (OR: 2.1, 95% CI 2.0-2.2, p-value < 0.0001). 64.5% of HDP infants received IV dextrose. 35.7% received mechanical or non-invasive ventilation. 8260/30,944 (26.7%) of HDP infants received intervention for hypoglycaemia alone (IV dextrose) with no other major intervention (respiratory support, parenteral nutrition, central line, arterial line or blood transfusion). Conclusions: The burden of maternal HDP on late preterm and term admissions to NNU is high with hypoglycaemia and respiratory disease being the main drivers for admission. Over one in four were admitted solely for management of hypoglycaemia. Further research should determine whether maternal antihypertensive agent choice or postnatal pathways may reduce NNU admission.Funding: Medical Research Council (MR/V006835/1).
Moore H, Battersby C, Piyasena C, et al., 2023, Assessing variation in neonatal sepsis screening across England, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 108, Pages: 430-431, ISSN: 1359-2998
Rees P, Callan C, Chadda K, et al., 2023, School-age outcomes of children after perinatal brain injury: a systematic review and meta-analysis, BMJ Paediatrics Open, Vol: 7, Pages: 1-14, ISSN: 2399-9772
Background Over 3000 children suffer a perinatal brain injury in England every year according to national surveillance. The childhood outcomes of infants with perinatal brain injury are however unknown.Methods A systematic review and meta-analyses were undertaken of studies published between 2000 and September 2021 exploring school-aged neurodevelopmental outcomes of children after perinatal brain injury compared with those without perinatal brain injury. The primary outcome was neurodevelopmental impairment, which included cognitive, motor, speech and language, behavioural, hearing or visual impairment after 5 years of age.Results This review included 42 studies. Preterm infants with intraventricular haemorrhage (IVH) grades 3–4 were found to have a threefold greater risk of moderate-to-severe neurodevelopmental impairment at school age OR 3.69 (95% CI 1.7 to 7.98) compared with preterm infants without IVH. Infants with perinatal stroke had an increased incidence of hemiplegia 61% (95% CI 39.2% to 82.9%) and an increased risk of cognitive impairment (difference in full scale IQ −24.2 (95% CI –30.73 to –17.67) . Perinatal stroke was also associated with poorer academic performance; and lower mean receptive −20.88 (95% CI –36.66 to –5.11) and expressive language scores −20.25 (95% CI –34.36 to –6.13) on the Clinical Evaluation of Language Fundamentals (CELF) assessment. Studies reported an increased risk of persisting neurodevelopmental impairment at school age after neonatal meningitis. Cognitive impairment and special educational needs were highlighted after moderate-to-severe hypoxic-ischaemic encephalopathy. However, there were limited comparative studies providing school-aged outcome data across neurodevelopmental domains and few provided adjusted data. Findings were further limited by the heterogeneity of studies.Conclusions Longitudinal population studies exploring childhood outcomes after perinatal b
Evans K, Battersby C, Boardman JP, et al., 2023, National priority setting partnership using a Delphi consensus process to develop neonatal research questions suitable for practice-changing randomised trials in the UK, Archives of Disease in Childhood: Fetal and Neonatal Edition, ISSN: 1359-2998
BACKGROUND: The provision of neonatal care is variable and commonly lacks adequate evidence base; strategic development of methodologically robust clinical trials is needed to improve outcomes and maximise research resources. Historically, neonatal research topics have been selected by researchers; prioritisation processes involving wider stakeholder groups have generally identified research themes rather than specific questions amenable to interventional trials. OBJECTIVE: To involve stakeholders including parents, healthcare professionals and researchers to identify and prioritise research questions suitable for answering in neonatal interventional trials in the UK. DESIGN: Research questions were submitted by stakeholders in population, intervention, comparison, outcome format through an online platform. Questions were reviewed by a representative steering group; duplicates and previously answered questions were removed. Eligible questions were entered into a three-round online Delphi survey for prioritisation by all stakeholder groups. PARTICIPANTS: One hundred and eight respondents submitted research questions for consideration; 144 participants completed round one of the Delphi survey, 106 completed all three rounds. RESULTS: Two hundred and sixty-five research questions were submitted and after steering group review, 186 entered into the Delphi survey. The top five ranked research questions related to breast milk fortification, intact cord resuscitation, timing of surgical intervention in necrotising enterocolitis, therapeutic hypothermia for mild hypoxic ischaemic encephalopathy and non-invasive respiratory support. CONCLUSIONS: We have identified and prioritised research questions suitable for practice-changing interventional trials in neonatal medicine in the UK at the present time. Trials targeting these uncertainties have potential to reduce research waste and improve neonatal care.
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
Burgess -Shannon J, Shefali-Patel D, Battersby C, 2023, Advances in neonatal care, Recent Advances in Pediatrics - 29, Editors: Kulkarni
Chapter highlighting recent advances in neonatal care in the last decade
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.
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.
Sawtell M, van Blankenstein E, Bilal T, et al., 2022, Views of parents, adults born preterm and professionals on linkage of real-world data of preterm babies, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 108, Pages: 194-199, ISSN: 1359-2998
Objective To explore views of parents of preterm babies, adults born preterm and professionals, on the linkage of real-world health and education data for research on improving future outcomes of babies born preterm.Design Three-stage mixed-methods participatory design involving focus groups, a national survey and interviews. Survey participants who expressed uncertainty or negative views were sampled purposively for invitation to interview. Mixed methods were used for data analysis.Setting and participants All data collection was online. Participants were: focus groups—17 parents; survey—499 parents, 44 adults born preterm (total 543); interviews—6 parents, 1 adult born preterm, 3 clinicians, 2 teachers.Results Three key themes were identified: (1) Data linkage and opt-out consent make sense for improving future outcomes. We found clear demand for better information on long-term outcomes and strong support for data linkage with opt-out consent as a means of achieving this. (2) Information requirements—what, how and when. There was support for providing information in different formats and discussing linkage near to, or following discharge from, the neonatal unit, but not sooner. (3) Looking to the future; the rights of young people. We identified a desire for individuals born preterm to be consulted in the future on the use of their data.Conclusion With appropriate information provision, at the right time, parents, adults born preterm and professionals are supportive of data linkage for research, including where temporary identifiers and opt-out consent are used. Resources are being co-produced to improve communication about routine data linkage.
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.
Hurrell A, Sparkes J, Duhig K, et al., 2022, Placental growth fActor Repeat sampling for Reduction of adverse perinatal Outcomes in women with suspecTed pre-eclampsia: study protocol for a randomised controlled trial (PARROT-2), Trials, Vol: 23, Pages: 1-12, ISSN: 1745-6215
BackgroundPre-eclampsia is a complex pregnancy disorder, characterised by new or worsening hypertension associated with multi-organ dysfunction. Adverse outcomes include eclampsia, liver rupture, stroke, pulmonary oedema, and acute kidney injury in the mother, and stillbirth, foetal growth restriction, and iatrogenic preterm delivery for the foetus. Angiogenic biomarkers, including placental growth factor (PlGF) and soluble fms-like tyrosine kinase 1 (sFlt-1), have been identified as valuable biomarkers for preterm pre-eclampsia, accelerating diagnosis and reducing maternal adverse outcomes by risk stratification, with enhanced surveillance for high-risk women. PlGF-based testing for suspected preterm pre-eclampsia has been incorporated into national guidance. The role of repeat PlGF-based testing and its effect on maternal and perinatal adverse outcomes have yet to be evaluated.MethodsThe PARROT-2 trial is a multi-centre randomised controlled trial of repeat revealed PlGF-based testing compared to repeat concealed testing, in women presenting with suspected pre-eclampsia between 22+0 and 35+6 weeks’ gestation. The primary objective is to establish whether repeat PlGF-based testing decreases a composite of perinatal severe adverse outcomes (stillbirth, early neonatal death, or neonatal unit admission). All women prior to enrolment in the trial will have an initial revealed PlGF-based test. Repeat PlGF-based tests will be performed weekly or two-weekly, depending on the initial PlGF-based test result, with results randomised to revealed or concealed.DiscussionNational guidance recommends that all women presenting with suspected preterm pre-eclampsia should have a single PlGF-based test when disease is first suspected, to help rule out pre-eclampsia. Clinical and cost-effectiveness of repeat PlGF-based testing has yet to be investigated. This trial aims to address whether repeat PlGF-based testing reduces severe maternal and perinatal adverse outcomes and whethe
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
Moss R, Lammons W, Johnson S, et al., 2022, More than words: Parent, Patient and Public Involvement perspectives on language used by clinical researchers in neonatal care, Early Human Development, Vol: 171, Pages: 1-3, ISSN: 0378-3782
In this qualitative study exploring parent views of information about research studies, we found they accepted uncertainty as justification, and that three key aspects of language - words, tone, and pace - influence parents' decision about their baby's inclusion. We recommend parents are routinely involved in developing information materials.
Beardmore-Gray A, Seed PT, Fleminger J, et al., 2022, Planned delivery or expectant management in preeclampsia: an individual participant data meta-analysis., American Journal of Obstetrics and Gynecology, Vol: 227, Pages: 218-230.e8, ISSN: 0002-9378
OBJECTIVE: Pregnancy hypertension is a leading cause of maternal and perinatal mortality and morbidity. Between 34+0 and 36+6 weeks gestation, it is uncertain whether planned delivery could reduce maternal complications without serious neonatal consequences. In this individual participant data meta-analysis, we aimed to compare planned delivery to expectant management, focusing specifically on women with preeclampsia. DATA SOURCES: We performed an electronic database search using a prespecified search strategy, including trials published between January 1, 2000 and December 18, 2021. We sought individual participant-level data from all eligible trials. STUDY ELIGIBILITY CRITERIA: We included women with singleton or multifetal pregnancies with preeclampsia from 34 weeks gestation onward. METHODS: The primary maternal outcome was a composite of maternal mortality or morbidity. The primary perinatal outcome was a composite of perinatal mortality or morbidity. We analyzed all the available data for each prespecified outcome on an intention-to-treat basis. For primary individual patient data analyses, we used a 1-stage fixed effects model. RESULTS: We included 1790 participants from 6 trials in our analysis. Planned delivery from 34 weeks gestation onward significantly reduced the risk of maternal morbidity (2.6% vs 4.4%; adjusted risk ratio, 0.59; 95% confidence interval, 0.36-0.98) compared with expectant management. The primary composite perinatal outcome was increased by planned delivery (20.9% vs 17.1%; adjusted risk ratio, 1.22; 95% confidence interval, 1.01-1.47), driven by short-term neonatal respiratory morbidity. However, infants in the expectant management group were more likely to be born small for gestational age (7.8% vs 10.6%; risk ratio, 0.74; 95% confidence interval, 0.55-0.99). CONCLUSION: Planned early delivery in women with late preterm preeclampsia provides clear maternal benefits and may reduce the risk of the infant being born small for gestational
Dallera G, Skopec M, Barlow J, et al., 2022, Review of a frugal cooling mattress to induce therapeutic hypothermia for treatment of hypoxic-ischaemic encephalopathy in the UK NHS, Globalization and Health, Vol: 18, ISSN: 1744-8603
Hypoxic ischaemic encephalopathy (HIE) is a major cause of neonatal mortality and disability in the United Kingdom (UK) and has significant human and financial costs. Therapeutic hypothermia (TH), which consists of cooling down the newborn’s body temperature, is the current standard of treatment for moderate or severe cases of HIE. Timely initiation of treatment is critical to reduce risk of mortality and disability associated with HIE. Very expensive servo-controlled devices are currently used in high-income settings to induce TH, whereas low-income settings rely on the use of low-tech devices such as water bottles, ice packs or fans. Cooling mattresses made with phase change materials (PCMs) were recently developed as a safe, efficient, and affordable alternative to induce TH in low-income settings. This frugal innovation has the potential to become a reverse innovation for the National Health Service (NHS) by providing a simple, efficient, and cost-saving solution to initiate TH in geographically remote areas of the UK where cooling equipment might not be readily available, ensuring timely initiation of treatment while waiting for neonatal transport to the nearest cooling centre. The adoption of PCM cooling mattresses by the NHS may reduce geographical disparity in the availability of treatment for HIE in the UK, and it could benefit from improvements in coordination across all levels of neonatal care given challenges currently experienced by the NHS in terms of constraints on funding and shortage of staff. Trials evaluating the effectiveness and safety of PCM cooling mattresses in the NHS context are needed in support of the adoption of this frugal innovation. These findings may be relevant to other high-income settings that experience challenges with the provision of TH in geographically remote areas. The use of promising frugal innovations such as PCM cooling mattresses in high-income settings may also contribute to challenge the dominant narrative that
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.
Uthaya S, Longford N, Battersby C, et al., 2022, Early versus later initiation of parenteral nutrition for very preterm infants: a propensity score matched observational study, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 107, ISSN: 1359-2998
Background: A current standard of care based on expert opinion is to commence parenteral nutrition (PN) within hours of birth in very preterm infants. Trials in critically ill adults and children, including term infants have found short and long-term harms from early initiation of PN. Methods: We included all infants born below 31 weeks gestation between January 2008 and December 2019 and admitted to National Health Service neonatal units in England and Wales. The source of data was the National Neonatal Research Database. The exposure was PN initiated within the first two days after birth (early) versus after the second postnatal day (late). We used propensity matched analysis to balance the two groups on background variables. The primary outcome was survival to discharge without major morbidity. Findings: Of 65,033 infants included, 16,294 infants formed the matched cohort, 8147 in each group. There was no evidence of a difference in survival to discharge without major morbidity (absolute rate difference (ARD) between early versus late 0·50%; 95% Confidence Interval (CI), -1·45, 0·45; p=0·29). Survival to discharge was higher in the early group (ARD -3·25%; 95% CI, -3·82 to -2·68; p<0·001) but they also had higher rates of late-onset sepsis (ARD -0·84%; 95% CI, -1·20 to -0·48; p<0·001), bronchopulmonary dysplasia (ARD -1·24%; 95% CI, -2·17 to -0·30; p=0·01), treatment for retinopathy of prematurity (ARD (-0·5%; 95% CI, -0·84 to -0.17; p<0·001), surgical procedures (ARD -0·8%; 95% CI, -1·40 to -0·20; p=0·01) and greater drop in weight z-score between birth and discharge (absolute difference 0·019; 95% CI, 0·003 to 0·039; p=0·02). Among infants that died the median age (days) at death was shorter in the late group (ARD 6; 95% CI, 6; p<0.001). Interpretation: These o
Ashworth D, Battersby C, Green M, et al., 2022, Which antihypertensive treatment is better for mild to moderate hypertension in pregnancy?, BMJ: British Medical Journal, Vol: 376, Pages: 1-4, ISSN: 0959-535X
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