Publications
193 results found
Jackson R, Woodward K, Ireland M, et al., 2023, Antenatal and neonatal exposure to SARS-CoV-2 and children’s development: a systematic review and meta-analysis, Pediatric Research, ISSN: 0031-3998
RECOVERY Collaborative Group, Gale C, 2023, Methylprednisolone, intravenous immunoglobulin, tocilizimab or anakinra for children with Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C) – report from a randomised, controlled, open-label, platform trial, The Lancet Child & Adolescent Health, ISSN: 2352-4642
Gale C, Sharkey D, Fitzpatrick KE, et al., 2023, Characteristics and outcomes of neonates hospitalised with SARS-CoV-2 infection in the United Kingdom by variant: a prospective national cohort study, Archives of Disease in Childhood: Fetal and Neonatal Edition, ISSN: 1359-2998
Objective: Neonatal infection with wildtype SARS-CoV-2 is rare and good outcomes predominate. We investigated neonatal outcomes using national population-level data to describe the impact of different SARS-CoV-2 variants.Design: Prospective population-based cohort studySetting: Neonatal, paediatric and paediatric intensive care inpatient care settings in the United KingdomPatients: Neonates (first 28 days after birth) with confirmed SARS-CoV-2 infection who received inpatient care, March 2020 to April 2022. Neonates were identified through active national surveillance with linkage to national SARS-CoV-2 testing data, routinely recorded neonatal data, paediatric intensive care data and obstetric and perinatal mortality surveillance data. Outcomes: Presenting signs, clinical course, severe disease requiring respiratory support are presented by the dominant SARS-CoV-2 variant in circulation at the time. Results: 344 neonates with SARS-CoV-2 infection received inpatient care; breakdown by dominant variant: 146 wildtype, 123 alpha, 57 delta and 18 omicron. Overall, 44.7% (153/342) neonates required respiratory support; short-term outcomes were good with 93.6% (322/344) of neonates discharged home. Eleven neonates died: seven unrelated to SARS-CoV-2 infection, four were attributed to neonatal SARS-CoV-2 infection (case fatality 4/344, 1.2% 95% CI 0.3%-3.0%) of which three were born preterm due to maternal COVID-19. More neonates were born very preterm (23/54) and required invasive ventilation (27/57) when delta variant was predominant, and all four SARS-CoV-2 related deaths occurred in this period.Conclusions: Inpatient care for neonates with SARS-CoV-2 was uncommon. Although rare, severe neonatal illness was more common during the delta variant period, potentially reflecting more severe maternal disease and associated preterm birth.
van Hasselt T, Gale C, Battersby C, et al., 2023, Paediatric intensive care admissions of preterm children born <32 weeks gestation: a national retrospective cohort study using data linkage, Archives of Disease in Childhood: Fetal and Neonatal Edition, ISSN: 1359-2998
Objective: Survival of babies born very preterm (<32 weeks gestational age) has increased, although preterm-born children may have ongoing morbidity. We aimed to investigate the risk of admission to paediatric intensive care units (PICUs) of children born very preterm following discharge home from neonatal care.Design: Retrospective cohort study, using data linkage of National Neonatal Research Database and the Paediatric Intensive Care Audit Network datasets.Setting: All neonatal units and PICUs in England and Wales.Patients: Children born very preterm between 1 January 2013 and 31 December 2018 and admitted to neonatal units.Main outcome measures: Admission to PICU after discharge home from neonatal care, before 2 years of age.Results: Of the 40 690 children discharged home from neonatal care, there were 2308 children (5.7%) with at least one admission to PICU after discharge. Of these children, there were 1901 whose first PICU admission after discharge was unplanned.The percentage of children with unplanned PICU admission varied by gestation, from 10.2% of children born <24 weeks to 3.3% born at 31 weeks.Following adjustment, unplanned PICU admission was associated with lower gestation, male sex (adjusted OR (aOR) 0.79), bronchopulmonary dysplasia (aOR 1.37), necrotising enterocolitis requiring surgery (aOR 1.39) and brain injury (aOR 1.42). For each week of increased gestation, the aOR was 0.90.Conclusions: Most babies born <32 weeks and discharged home from neonatal care do not require PICU admission in the first 2 years. The odds of unplanned admissions to PICU were greater in the most preterm and those with significant neonatal morbidity.Data availability statement:Data may be obtained from a third party and are not publicly available. Data may be obtained from a third party and are not publicly available. PICANet data may be requested from the data controller, the Healthcare Quality Improvement Partnership (HQIP). A Data Access Request Form can be o
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, Vol: 108, Pages: 569-574, 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.
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, Vol: 177, Pages: 1085-1095, 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
Iio K, Hanna H, Beykou M, et al., 2023, The role of procalcitonin in predicting complications of Kawasaki disease, Archives of Disease in Childhood, Vol: 108, Pages: 862-864, ISSN: 0003-9888
Ali S, Mactier H, Morelli A, et al., 2023, Neonatal outcomes of maternal SARS-CoV-2 infection in the UK: a prospective cohort study using active surveillance, Pediatric Research, Vol: 94, Pages: 1203-1208, ISSN: 0031-3998
Background:Newborns may be affected by maternal SARS-CoV-2 infection during pregnancy. We aimed to describe the epidemiology, clinical course and short-term outcomes of babies admitted to a neonatal unit (NNU) following birth to a mother with confirmed SARS-CoV-2 infection within 7 days of birth.Methods:This is a UK prospective cohort study; all NHS NNUs, 1 March 2020 to 31 August 2020. Cases were identified via British Paediatric Surveillance Unit with linkage to national obstetric surveillance data. Reporting clinicians completed data forms. Population data were extracted from the National Neonatal Research Database.Results:A total of 111 NNU admissions (1.98 per 1000 of all NNU admissions) involved 2456 days of neonatal care (median 13 [IQR 5, 34] care days per admission). A total of 74 (67%) babies were preterm. In all, 76 (68%) received respiratory support; 30 were mechanically ventilated. Four term babies received therapeutic hypothermia for hypoxic ischaemic encephalopathy. Twenty-eight mothers received intensive care, with four dying of COVID-19. Eleven (10%) babies were SARS-CoV-2 positive. A total of 105 (95%) babies were discharged home; none of the three deaths before discharge was attributed to SARS-CoV-2.Conclusion:Babies born to mothers with SARS-CoV-2 infection around the time of birth accounted for a low proportion of total NNU admissions over the first 6 months of the UK pandemic. Neonatal SARS-CoV-2 was uncommon.Study registration:ISRCTN60033461; protocol available at http://www.npeu.ox.ac.uk/pru-mnhc/research-themes/theme-4/covid-19.
Baba A, Webbe J, Butcher N, et al., 2023, Heterogeneity and gaps in reporting primary outcomes from neonatal trials, Pediatrics, Vol: 152, ISSN: 0031-4005
Objective: Clear outcome reporting in clinical trials facilitates accurate interpretation andapplication of findings and improves evidence-informed decision-making. Standardized coreoutcomes for reporting neonatal trials have been developed, but little is known about howprimary outcomes are reported in neonatal trials. Our aim was to identify strengths andweaknesses of primary outcome reporting in recent neonatal trials.Methods: Neonatal trials including ≥100 participants/arm published between 2015-2020 with atleast one primary outcome from a neonatal core outcome set were eligible. Raters recruited fromCochrane Neonatal were trained to evaluate the trials’ primary outcome reporting completenessusing relevant items from CONSORT 2010 and CONSORT-Outcomes 2022 pertaining to thereporting of the definition, selection, measurement, analysis, and interpretation of primary trialoutcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies betweenraters were analyzed.Results: Outcome reporting evaluations were completed for 36 included neonatal trials by 39raters. Levels of outcome reporting completeness were highly variable. All trials fully reportedthe primary outcome measurement domain, statistical methods used to compare treatmentgroups, and participant flow. Yet, only 28% of trials fully reported on minimal importantdifference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and42% on handling of outcome multiplicity.Conclusions: Primary outcome reporting in neonatal trials often lacks key information neededfor interpretability of results, knowledge synthesis, and evidence-informed decision-making inneonatology. Use of existing outcome reporting guidelines by trialists, journals, and peerreviewers will enhance transparent reporting of neonatal trials.
Webbe J, Baba A, Butcher N, et al., 2023, Strengthening reporting of neonatal trials, Pediatrics, Vol: 152, ISSN: 0031-4005
Background and Objectives: There is variability in the selection and reporting of outcomes in neonatal trials with key information frequently omitted. This can impact applicability of trial findings to clinicians, families, and caregivers, and impair evidence synthesis. The Neonatal Core Outcomes Set describes outcomes agreed as clinically important that shouldbe assessed in all neonatal trials, and CONSORT-Outcomes 2022 is a new, harmonized,evidence-based reporting guideline for trial outcomes. We reviewed published trials usingCONSORT-Outcomes 2022 guidance to identify exemplars of neonatal core outcomereporting to strengthen description of outcomes in future trial publications.Methods: Neonatal trials including >100 participants per arm published between 2015-2020with a primary outcome included in the Neonatal Core Outcome Set were identified. Primaryoutcome reporting was reviewed using CONSORT 2010 and CONSORT-Outcomes 2022guidelines by assessors recruited from Cochrane Neonatal. Examples of clear and completeoutcome reporting were identified with verbatim text extracted from trial reports.Results: Thirty-six trials were reviewed by 39 assessors. Examples of good reporting forCONSORT 2010 and CONSORT-Outcomes 2022 criteria were identified and subdivided intothree outcome categories: “survival”, “short-term neonatal complications”, and “long-termdevelopmental outcomes” depending on the core outcomes to which they relate. Theseexamples are presented to strengthen future research reporting.Conclusions: We have identified examples of good trial outcome reporting. These illustratehow important neonatal outcomes should be reported to meet the CONSORT 2010 andCONSORT-Outcomes 2022 guidelines. Emulating these examples will improve thetransmission of information relating to outcomes and reduce associated research waste.
van Hasselt TJ, Kanthimathinathan HK, Kothari T, et al., 2023, Impact of prematurity on long-stay paediatric intensive care unit admissions in England 2008-2018, BMC Pediatrics, Vol: 23, Pages: 1-12, ISSN: 1471-2431
BACKGROUND: Survival following extreme preterm birth has improved, potentially increasing the number of children with ongoing morbidity requiring intensive care in childhood. Previous single-centre studies have suggested that long-stay admissions in paediatric intensive care units (PICUs) are increasing. We aimed to examine trends in long-stay admissions (≥28 days) to PICUs in England, outcomes for this group (including mortality and PICU readmission), and to determine the contribution of preterm-born children to the long-stay population, in children aged <2 years. METHODS: Data was obtained from the Paediatric Intensive Care Audit Network (PICANet) for all children <2 years admitted to National Health Service PICUs from 1/1/2008 to 31/12/2018 in England. We performed descriptive analysis of child characteristics and PICU outcomes. RESULTS: There were 99,057 admissions from 67,615 children. 2,693 children (4.0%) had 3,127 long-stays. Between 2008 and 2018 the annual number of long-stay admissions increased from 225 (2.7%) to 355 (4.0%), and the proportion of bed days in PICUs occupied by long-stay admissions increased from 24.2% to 33.2%. Of children with long-stays, 33.5% were born preterm, 53.5% were born at term, and 13.1% had missing data for gestational age. A considerable proportion of long-stay children required PICU readmission before two years of age (76.3% for preterm-born children). Observed mortality during any admission was also disproportionately greater for long-stay children (26.5% for term-born, 24.8% for preterm-born) than the overall rate (6.3%). CONCLUSIONS: Long-stays accounted for an increasing proportion of PICU activity in England between 2008 and 2018. Children born preterm were over-represented in the long-stay population compared to the national preterm birth rate (8%). These results have significant implications for future research into paediatric morbidity, and for planning future PICU service provision.
Lee SI, Hanley S, Vowles Z, et al., 2023, The development of a core outcome set for studies of pregnant women with multimorbidity, BMC Medicine, Vol: 21, Pages: 1-15, ISSN: 1741-7015
Background: Heterogeneity in reported outcomes can limit the synthesis of research evidence. A core outcome set informs what outcomes are important and should be measured as minimum in all future studies. We report the development of a core outcome set applicable to observational and interventional studies of pregnant women with multimorbidity.Methods: We developed the core outcome set in four stages: (i) a systematic literature search, (ii) three focus groups with UK stakeholders, (iii) two rounds of Delphi surveys with international stakeholders, and (iv) two international virtual consensus meetings. Stakeholders included women with multimorbidity and experience of pregnancy in the last five years, or are planning a pregnancy, their partners, health or social care professionals and researchers. Study adverts were shared through stakeholder charities and organisations.Results: Twenty-six studies were included in the systematic literature search (2017 to 2021) reporting 185 outcomes. Thematic analysis of the focus groups added a further 28 outcomes. Two hundred and nine stakeholders completed the first Delphi survey. One hundred and sixteen stakeholders completed the second Delphi survey where 45 outcomes reached Consensus In (≥70% of all participants rating an outcome as Critically Important). Thirteen stakeholders reviewed 15 Borderline outcomes in the first consensus meeting and included seven additional outcomes. Seventeen stakeholders reviewed these 52 outcomes in a second consensus meeting, the threshold was ≥80% of all participants voting for inclusion. The final core outcome set included 11 outcomes. The five maternal outcomes were: maternal death, severe maternal morbidity, change in existing long-term conditions (physical and mental), quality and experience of care, and development of new mental health conditions. The six child outcomes were: survival of baby, gestational age at birth, neurodevelopmental conditions/impairment, quality of life, birth
Molloy EJ, Branagan A, Hurley T, et al., 2023, Neonatal Encephalopathy and Hypoxic-Ischemic Encephalopathy: moving from controversy to consensus definitions, Pediatric Research, ISSN: 0031-3998
Lugg-Widger F, 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
<jats:p>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 gover
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
Aim:To undertake a systematic review and meta-analysis exploring school-aged neurodevelopmental outcomes of children after low-grade intraventricular haemorrhage (IVH).Methods:The 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.Results:This 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.Interpretation:This 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.
Prior E, Uthaya S, Gale C, 2023, Measuring body composition in children: research and practice, Archives of Disease in Childhood, Vol: 108, Pages: 285-289, ISSN: 0003-9888
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
Mitra S, Whitehead L, Smith K, et al., 2023, Prophylactic cyclo-oxygenase inhibitor drugs for the prevention of morbidity and mortality in extremely preterm infants: a clinical practice guideline incorporating family values and preferences, Archives of Disease in Childhood: Fetal and Neonatal Edition, ISSN: 1359-2998
Importance: Prophylactic cyclooxygenase inhibitors (COX-Is) such as indomethacin, ibuprofen and acetaminophen may prevent morbidity and mortality in extremely preterm infants (born ≤28 weeks’ gestation). However, there is controversy around which COX-I, if any, is the most effective and safest, which has resulted in considerable variability in clinical practice. Objective: To develop rigorous and transparent clinical practice guideline recommendations for the prophylactic use of COX-I drugs for the prevention of mortality and morbidity in extremely preterm infants.Methods: The GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence-to-Decision framework for multiple comparisons was used to develop the guideline recommendations. A 12-member panel, including five experienced neonatal care providers, two methods experts, one pharmacist, two parents of former extremely preterm infants and two adults born extremely preterm, was convened. A rating of the most important clinical outcomes was established a priori. Evidence from a Cochrane network meta-analysis, and a cross-sectional mixed-methods study exploring family values and preferences were used as the primary sources of evidence. Recommendations: The panel recommended that prophylaxis with intravenous indomethacin may be considered in extremely preterm infants [conditional recommendation, moderate certainty in estimate of effects]. Shared decision making with parents was encouraged to evaluate their values and preferences prior to therapy. The panel recommended against routine use of ibuprofen prophylaxis in this gestational age group [conditional recommendation, low certainty in the estimate of effects]. The panel strongly recommended against use of prophylactic acetaminophen [strong recommendation, very low certainty in estimate of effects] until further research evidence is available.
van Hasselt T, Webster K, Gale C, et al., 2023, Children born preterm admitted to paediatric intensive care for bronchiolitis: a systematic review and meta-analysis, BMC Pediatrics, Vol: 23, Pages: 1-12, ISSN: 1471-2431
BackgroundTo undertake a systematic review of studies describing the proportion of children admitted to a paediatric intensive care unit (PICU) for respiratory syncytial virus (RSV) and/or bronchiolitis who were born preterm, and compare their outcomes in PICU with children born at term.MethodsWe searched Medline, Embase and Scopus. Citations and references of included articles were searched. We included studies published from the year 2000 onwards, from high-income countries, that examined children 0-18 years of age, admitted to PICU from the year 2000 onwards for RSV and/or bronchiolitis.The primary outcome was the percentage of PICU admissions born preterm, and secondary outcomes were observed relative risks of invasive mechanical ventilation and mortality within PICU.We used the Joanna Briggs Institute Checklist for Analytical Cross-Sectional Studies to assess risk of bias. ResultsWe included 31 studies, from 16 countries, including a total of 18,331 children.Following meta-analysis, the pooled estimate for percentage of PICU admissions for RSV/bronchiolitis who were born preterm was 31% (95% confidence interval: 27% to 35%). Children born preterm had a greater risk of requiring invasive ventilation compared to children born at term (relative risk 1.57, 95% confidence interval 1.25 to 1.97, I2 = 38%). However, we did not observe a significant increase in the relative risk for mortality within PICU for preterm-born children (relative risk 1.10, 95% confidence interval: 0.70 to 1.72, I2 = 0%), although the mortality rate was low across both groups.The majority of studies (n=26, 84%) were at high risk of bias.ConclusionsAmong PICU admissions for bronchiolitis, preterm-born children are over-represented compared with the preterm birth rate (preterm birth rate 4.4% to 14.4% across countries included in review). Preterm-born children are at higher risk of mechanical ventilation compared to those born at term.
Sakonidou S, Kotzamanis S, Tallett A, et al., 2023, Parents’ Experiences of Communication in neonatal care (PEC): a neonatal survey refined for real-time parent feedback, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 108, Pages: 416-420, ISSN: 1359-2998
Objective Assessing parent experiences of neonatal services can help improve quality of care; however, there is no formally evaluated UK instrument available to assess this prospectively. Our objective was to refine an existing retrospective survey for ‘real-time’ feedback.Methods Co-led by a parent representative, we recruited a convenience sample of parents of infants in a London tertiary neonatal unit. Our steering group selected questions from the existing retrospective 61-question Picker survey (2014), added and revised questions assessing communication and parent involvement. We established face validity, ensuring questions adequately captured the topic, conducted parent cognitive interviews to evaluate parental understanding of questions,and adapted the survey in three revision cycles. We evaluated survey performance.Results The revised Parents’ Experiences of Communication in Neonatal Care (PEC) survey contains 28 questions (10 new) focusing on communication and parent involvement. We cognitively interviewed six parents, and 67 parents completed 197 PEC surveys in the survey performance evaluation. Missing entries exceeded 5% for nine questions; we removed one and format-adjusted the rest as they had performed well during cognitive testing. There was strong inter-item correlation between two question pairs; however, all were retained as they individually assessed important concepts.Conclusion Revised from the original 61-question Picker survey, the 28-question PEC survey is the first UK instrument formally evaluated to assess parent experience while infants are still receiving neonatal care. Developed with parents, it focuses on communication and parent involvement, enabling continuous assessment and iterative improvement of family-centred interventions in neonatal care.
Goulding A, McQuaid F, Lindsay L, et al., 2023, Confirmed SARS-CoV-2 infection in Scottish neonates 2020-2022: a national, population-based cohort study, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 108, Pages: 367-372, ISSN: 1359-2998
Objectives: To examine neonates in Scotland aged 0–27 days with SARS-CoV-2 infection confirmed by viral testing; the risk of confirmed neonatal infection by maternal and infant characteristics; and hospital admissions associated with confirmed neonatal infections.Design: Population-based cohort study.Setting and population: All live births in Scotland, 1 March 2020–31 January 2022.Results: There were 141 neonates with confirmed SARS-CoV-2 infection over the study period, giving an overall infection rate of 153 per 100 000 live births (141/92 009, 0.15%). Among infants born to women with confirmed infection around the time of birth, the confirmed neonatal infection rate was 1812 per 100 000 live births (15/828, 1.8%). Two-thirds (92/141, 65.2%) of neonates with confirmed infection had an associated admission to neonatal or (more commonly) paediatric care. Six of these babies (6/92, 6.5%) were admitted to neonatal and/or paediatric intensive care; however, none of these six had COVID-19 recorded as their main diagnosis. There were no neonatal deaths among babies with confirmed infection.Implications and relevance: Confirmed neonatal SARS-CoV-2 infection was uncommon over the first 23 months of the pandemic in Scotland. Secular trends in the neonatal confirmed infection rate broadly followed those seen in the general population, although at a lower level. Maternal confirmed infection at birth was associated with an increased risk of neonatal confirmed infection. Two-thirds of neonates with confirmed infection had an associated admission to hospital, with resulting implications for the baby, family and services, although their outcomes were generally good. Ascertainment of confirmed infection depends on the extent of testing, and this is likely to have varied over time and between groups: the extent of unconfirmed infection is inevitably unknown.
Baskaran D, Gale C, Jawad S, et al., 2023, Kernicterus in neonates from ethnic minorities in the UK, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 108, Pages: 432-433, 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
Webbe J, Allin B, Knight M, et al., 2023, How to reach agreement: the impact of different analytical approaches to Delphi process results in core outcomes set development, Trials, Vol: 24, ISSN: 1745-6215
Background: Core outcomes sets are increasingly used to define research outcomes that are most important for a condition. Different consensus methods are used in the development of core outcomes sets; the most common is the Delphi process. Delphi methodology is increasingly standardised for core outcomes set development, butuncertainties remain. We aimed to empirically test how the use of different summary statistics and consensus criteria impact Delphi process results.Methods: Results from two unrelated child health Delphi processes were analysed. Outcomes were ranked by mean, median, or rate of exceedance, and then pairwisecomparisons were undertaken to analyse whether the rankings were similar. The correlation coefficient for each comparison was calculated, and Bland-Altman plotsproduced. Youden’s index was used to assess how well the outcomes ranked highest by each summary statistic matched the final core outcomes sets. Consensus criteria identified in a review of published Delphi processes were applied to the results of the two child-health Delphi processes. The size of the consensus setsproduced by different criteria was compared, and Youden’s index was used to assess how well the outcomes that met different criteria matched the final core outcomes sets.Results: Pairwise comparisons of different summary statistics produced similar correlation coefficients. Bland-Altman plots showed that comparisons involving ranked medians had wider variation in the ranking. No difference in Youden’s index for the summary statistics was found.Different consensus criteria produced widely different sets of consensus outcomes (Range: 5-44 included outcomes). They also showed differing abilities to identify core outcomes (Youden’s index Range: 0.32-0.92). The choice of consensus criteria had a large impact on Delphi results.Discussion: The use of different summary statistics is unlikely to affect how outcomes are ranked during a Delphi process: mean, media
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.
Kumar A, Tachibana Y, Sirimanna C, et al., 2023, Inclusive jet and hadron suppression in a multistage approach, PHYSICAL REVIEW C, Vol: 107, ISSN: 2469-9985
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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
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