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Journal articleYao 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: 2044-6055Objective: 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.
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Journal articleHyde MJ, Jeffries S, McCarthy RL, et al., 2022,
Infant body mass index, eczema and atopy at one year of age in relation to mode of delivery
, CLINICAL AND EXPERIMENTAL ALLERGY, Vol: 52, Pages: 1351-1354, ISSN: 0954-7894 -
Journal articleModi N, 2023,
The future of perinatal research
, EUROPEAN JOURNAL OF PEDIATRICS, ISSN: 0340-6199 -
Journal articleSawtell 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: 1359-2998Objective 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.
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Journal articleHarbottle V, Arnott B, Gale C, et al., 2022,
Identifying common health indicators from paediatric core outcome sets: a systematic review with narrative synthesis using the WHO International Classification of Functioning, Health and Disability
, BMJ Paediatrics Open, Vol: 6, Pages: 1-13, ISSN: 2399-9772Background Indicators of child health have the potential to inform societal conversations, decision-making and prioritisation. Paediatric core outcome sets are an increasingly common way of identifying a minimum set of outcomes for trials within clinical groups. Exploring commonality across existing sets may give insight into universally important and inclusive child health indicators.Methods A search of the Core Outcome Measures in Effectiveness Trial register from 2008 to 2022 was carried out. Eligible articles were those reporting on core outcome sets focused on children and young people aged 0–18 years old. The International Classification of Functioning, Disability and Health (ICF) was used as a framework to categorise extracted outcomes. Information about the involvement of children, young people and their families in the development of sets was also extracted.Results 206 articles were identified, of which 36 were included. 441 unique outcomes were extracted, mapping to 22 outcome clusters present across multiple sets. Medical diagnostic outcomes were the biggest cluster, followed by pain, communication and social interaction, mobility, self-care and school. Children and young people’s views were under-represented across core outcome sets, with only 36% of reviewed studies including them at any stage of development.Conclusions Existing paediatric core outcome sets show overlap in key outcomes, suggesting the potential for generic child health measurement frameworks. It is unclear whether existing sets best reflect health dimensions important to children and young people, and there is a need for better child and young person involvement in health indicator development to address this.
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Journal articleEvans 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: 2044-6055Introduction 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.
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Journal articleHurrell 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: 1745-6215BackgroundPre-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
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Journal articleWoodward K, Cornish RP, Gale C, et al., 2022,
Effect of SARS-CoV-2 infection in neonates or in pregnancy on developmental outcomes at 21-24 months (SINEPOST): study protocol for a prospective cohort study
, BMJ Paediatrics Open, Vol: 6, Pages: 1-6, ISSN: 2399-9772Introduction Exposure to SARS-CoV-2 during pregnancy or in the neonatal period may impact fetal or neonatal brain development either through direct central nervous system infection or indirectly through the adverse effects of viral infection-related inflammation in the mother or newborn infant. This study aims to determine whether there are early neurodevelopmental effects of SARS-CoV-2 infection.Methods and analysis We will conduct a prospective national population-based cohort study of children aged 21–24 months who were born at term (≥37 weeks’ gestation) between 1 March 2020 and 28 February 2021 and were either antenatally exposed, neonatally exposed or unexposed (comparison cohort) to SARS-CoV-2. Nationally, hospitals will identify and approach parents of children eligible for inclusion in the antenatally and neonatally exposed cohorts using information from the UK Obstetric Surveillance System (UKOSS) and British Paediatric Surveillance Unit (BPSU) national surveillance studies and will identify and approach eligible children for the comparison cohort through routine birth records. Parents will be asked to complete questionnaires to assess their child’s development at 21–24 months of age. Outcome measures comprise the Ages and Stages Questionnaire, Third Edition (ASQ-3), Ages and Stages Questionnaire Social-Emotional, Second Edition (ASQ-SE-2), Liverpool respiratory symptoms questionnaire and questionnaire items to elicit information about healthcare usage. With parental consent, study data will be linked to routine health and education records for future follow-up. Regression models will compare ASQ-3 and ASQ-SE-2 scores and proportions, frequency of respiratory symptoms and healthcare usage between the exposed and comparison cohorts, adjusting for potential confounders.Ethics and dissemination Ethics approval was obtained from the London-Westminster Research Ethics Committee. Findings will be disseminated in scientific conference p
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Journal articleEngjom HM, Ramakrishnan R, Vousden N, et al., 2022,
Severity of maternal SARS-CoV-2 infection and perinatal outcomes of women admitted to hospital during the omicron variant dominant period using UK Obstetric Surveillance System data: prospective, national cohort study
, BMJ Medicine, Vol: 1, ISSN: 2754-0413OBJECTIVES: To describe the severity of maternal infection when the omicron SARS-CoV-2 variant (B.1.1.529) was dominant (15 December 2021 to 14 March 2022) and describe outcomes by symptoms and vaccination status. DESIGN: Prospective, national cohort study using the UK Obstetric Surveillance System. SETTING: 94 hospitals in the UK with a consultant led maternity unit. PARTICIPANTS: Pregnant women admitted to hospital for any cause with a positive SARS-CoV-2 test. MAIN OUTCOME MEASURES: Symptomatic or asymptomatic infection, vaccination status by doses before admission, and severity of maternal infection (moderate or severe infection according to modified World Health Organization's criteria). RESULTS: Of 3699 women who were admitted to hospital, 986 (26.7%, 95% confidence interval 25.3% to 28.1%) had symptoms; of these, 144 (14.6%, 12.5% to 17.0%) had a moderate to severe infection, 99 (10.4%, 8.6% to 12.5%) of 953 received respiratory support, and 30 (3.0%, 2.1% to 4.3%) were admitted to an intensive care unit. Covid-19 specific drug treatment was given to 13 (43.3%) of the 30 women in intensive care. Four women with symptoms died (0.4%, 0.1% to 1.1%). Vaccination status was known for 845 (85.6%) women with symptoms; 489 (58.9%) were unvaccinated and only 55 (6.5%) had three doses. Moderate to severe infection was reported for 93 (19.0%) of 489 unvaccinated women with symptoms, decreasing to three (5.5%) of 55 after three doses. Among the 30 women with symptoms who were admitted to intensive care, 23 (76.7%) were unvaccinated and none had received three doses. CONCLUSION: Most women with severe covid-19 disease were unvaccinated and vaccine coverage among pregnant women admitted to hospital with SARS-CoV-2 was low. Ongoing action to prioritise and advocate for vaccine uptake in pregnancy is essential. A better understanding of the persistent low use of drug treatments is an urgent priority. TRIAL REGISTRATION: ISRCTN 40092247.
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Journal articleWebbe 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: 2399-9772BackgroundParenteral 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
This data is extracted from the Web of Science and reproduced under a licence from Thomson Reuters. You may not copy or re-distribute this data in whole or in part without the written consent of the Science business of Thomson Reuters.
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Neonatal Medicine Research Group and Neonatal Data Analysis Unit Manager
(All research related queries)
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Chelsea and Westminster Hospital
ndau@imperial.ac.uk
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