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Journal articleHaumont D, Modi N, Saugstad OD, et al., 2020,
Evaluating preterm care across Europe using the eNewborn European Network database
, Pediatric Research, Vol: 88, Pages: 484-495, ISSN: 0031-3998BackgroundThe inefficiency of recording data repeatedly limits the number of studies conducted. Here we illustrate the wider use of data captured as part of the European eNewborn benchmarking programme.MethodsWe extracted data on 39,529 live-births from 22 weeks 0 days to 31 weeks 6 days gestational age (GA) or ≤1500 g birth weight. We explored relationships between delivery room care and Apgar scores on mortality and bronchopulmonary dysplasia (BPD) and calculated the time needed for each country to detect a clinically relevant change in these outcomes following a hypothetical intervention.ResultsEarly neonatal, neonatal, and in-hospital mortality were 3.90% (95% CI 3.71, 4.09), 6.00% (5.77, 6.24) and 7.57% (7.31, 7.83), respectively. The odds of death were greater with decreasing GA, lower Apgar scores, growth restriction, male sex, multiple birth and no antenatal steroids. Relationships for BPD were similar. The time required for participating countries to achieve 80% power to detect a relevant change in outcomes following a hypothetical intervention in 23–25 weeks’ GA infants ranged from 12 years for neonatal mortality and 22 years for BPD compared to 1 year for the whole network.ConclusionsThe eNewborn platform offers opportunity to drive efficiencies in benchmarking, quality control and research.
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Journal articleDorling J, Tume LN, Arch B, et al., 2020,
Gastric residual volume measurement in British neonatal intensive care units: a survey of practice
, BMJ Paediatrics Open, Vol: 4, ISSN: 2399-9772Objective: Despite little evidence, the practice of routine gastric residual volume (GRV) measurement to guide enteral feeding in neonatal units is widespread. Due to increased interest in this practice, and to examine trial feasibility, we aimed to determine enteral feeding and GRV measurement practices in British neonatal units.Design & Setting: An online survey was distributed via email to all neonatal units and networks in England, Scotland and Wales. A clinical nurse, senior doctor and dietitian were invited to collaboratively complete the survey and submit a copy of relevant guidelines. Results: 95/184 (51.6%) approached units completed the survey, 81/95 (85.3%) reported having feeding guidelines and 28 guidelines were submitted for review. The majority of units used intermittent (90/95) gastric feeds as their primary feeding method. 42/95 units reported specific guidance for measuring and interpreting GRV. 20/90 units measured GRV before every feed, 39/90 at regular time-intervals (most commonly 4-6 hourly 35/39) and 26/90 when felt to be clinically indicated. Most units reported uncertainty on the utility of aspirate volume for guiding feeding decisions; 13/90 reported that aspirate volume affected decisions ‘very much’. In contrast, aspirate colour was reported to affect decisions ‘very much’ by 37/90 of responding units. Almost half, 44/90, routinely returned aspirates to the stomach. Conclusions: Routine GRV measurement is part of standard practice in British neonatal units, although there was inconsistency in how frequently to measure or how to interpret the aspirate. Volume was considered less important than colour of the aspirate.
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Journal articleLittle M, Dupre S, Wormald J, et al., 2020,
Surgical intervention for paediatric infusion-related extravasation injury: a systematic review
, BMJ Open, Vol: 10, Pages: 1-14, ISSN: 2044-6055ObjectivesThis systematic review aims to assess the quality of literature supporting surgical interventions for paediatric extravasation injury and to determine whether there is sufficient evidence to support invasive techniques in children.MethodsWe performed a systematic review by searching Ovid MEDLINE and EMBASE as well as AMED, CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews and clinicaltrials.gov from inception to February 2019. Studies other than case reports were eligible for inclusion if the population was younger than 18 years old, there was a surgical intervention aimed at treating extravasation injury and they reported on outcomes. Study quality was graded according to the National Institutes of Health (NIH) study quality assessment tools.Results26 studies involving 728 children were included – one before-and-after study and 25 case series. Extravasation injuries were mainly confined to skin and subcutaneous tissues but severe complications were also encountered, including amputation (one toe and one below elbow). Of the surgical treatments described, the technique of multiple puncture wounds and instillation of saline and/or hyaluronidase was the most commonly used. However, there were no studies in which its effectiveness was tested against another treatment or a control and details of functional and aesthetic outcomes were generally lacking. ConclusionSurgical management is commonly reported in the literature in cases where there is significant soft tissue injury but as there are no comparative studies, it is unclear whether this is optimal. Further observational and experimental research evaluating extravasation injuries, including a centralized extravasation register using a universal grading scheme and core outcome set with adequate follow-up, are required to provide evidence to guide clinician decision-making.
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Journal articleWong HS, Wadon M, Evans A, et al., 2020,
Contribution of de novo and inherited rare CNVs to very preterm birth
, JOURNAL OF MEDICAL GENETICS, Vol: 57, Pages: 552-557, ISSN: 0022-2593- Author Web Link
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Journal articleWong HS, Hopkins L, ODonovan MC, et al., 2020,
Pilot study to establish a prospective neonatal cohort: Study of Preterm Infants and Neurodevelopmental Genes (SPRING)
, BMJ Paediatrics Open, Vol: 4, ISSN: 2399-9772Background: Genetic risk variants and preterm birth are early and potent risk factors for later neuropsychiatric disorders. To understand the interrelationships between these factors, a large-scale genetic study of very preterm (VPT, <32 weeks gestation) infants with prospective follow-up is required. In this paper we describe a streamlined study approach, using efficient processes for biological and clinical data collection, to feasibly establish such a cohort. Methods: We sought to recruit 500 VPT families within a one-year period from neonatal units. Treating clinical teams recruited eligible participants, obtained parent consent, collected blood samples and posted specimens to the research laboratory. We extracted all clinical data from the National Neonatal Research Database, an existing UK resource that captures daily patient-level data on all VPT infants. Results: Between May 2017 and June 2018, we established a cohort of 848 VPT infants and their parents from 60 English neonatal units. The study population (median (inter-quartile range) gestation 28.9 (26-30) weeks; birthweight 1120 (886-1420) grams) represented 18.9% of eligible infants born at the study sites during the recruitment period (n= 4491). From the subset of 521 complete family trios, we successfully completed genotyping for 510 (97.9%) trios. Of the original 883 infants whose parents consented to participate, the parents of 796 (90.1%) infants agreed to future data linkage and 794 (89.9%) agreed to be recalled. Conclusion: We demonstrate the feasibility and acceptability of streamlined strategies for genetic, neonatal and longitudinal data collection and provide a template for future cost-effective and efficient cohort development.
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Journal articleHo A, Webster L, Bowen L, et al., 2020,
Research priorities for pregnancy hypertension: a UK priority setting partnership with the James Lind Alliance.
, BMJ Open, Vol: 10, Pages: 1-8, ISSN: 2044-6055OBJECTIVES: To identify research priorities for hypertensive disorders of pregnancy from individuals with lived experience and healthcare professionals. DESIGN: Prospective surveys and consensus meetings using principles outlined by the James Lind Alliance. SETTING: UK. METHODS: A steering group was established and 'uncertainties' were gathered using an online survey and literature search. An interim online survey ranked long-listed questions and the top 10 research questions were reached by consensus at a final prioritisation workshop. PARTICIPANTS: Women, partners, relatives and friends of those with lived experience of pregnancy hypertension, researchers and healthcare professionals. RESULTS: The initial online survey was answered by 278 participants (180 women with lived experience, 9 partners/relatives/friends, 71 healthcare professionals and 18 researchers). Together with a literature search, this identified 764 questions which were refined into 50 summary questions. All summary questions were presented in an interim prioritisation survey that was answered by 155 participants (87 women with lived experience, 4 partners/relatives/friends, 49 healthcare professionals and 15 researchers). The top 25 highest ranked questions were considered by the final prioritisation workshop. The top 10 uncertainties were identified by consensus and ranked as follows in order of priority: long-term consequences of pregnancy hypertension (for the woman and baby), short-term complications of pregnancy hypertension (for the woman and baby), screening tests for pre-eclampsia, prevention of long-term problems (for the woman and baby), causes of pregnancy hypertension, prevention of recurrent pregnancy hypertension, educational needs of healthcare professionals, diagnosis of pre-eclampsia, management of pregnancy hypertension, provision of support for women and families. CONCLUSIONS: Research priorities shared by those with lived experience of pregnancy hypertension and healthcare pro
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Journal articleDuffy JMN, Cairns AE, Magee LA, et al., 2020,
Standardising definitions for the pre-eclampsia core outcome set: A consensus development study
, Pregnancy Hypertension, Vol: 21, Pages: 208-217, ISSN: 2210-7789OBJECTIVES: To develop consensus definitions for the core outcome set for pre-eclampsia. STUDY DESIGN: Potential definitions for individual core outcomes were identified across four formal definition development initiatives, nine national and international guidelines, 12 Cochrane systematic reviews, and 79 randomised trials. Eighty-six definitions were entered into the consensus development meeting. Ten healthcare professionals and three researchers, including six participants who had experience of conducting research in low- and middle-income countries, participated in the consensus development process. The final core outcome set was approved by an international steering group. RESULTS: Consensus definitions were developed for all core outcomes. When considering stroke, pulmonary oedema, acute kidney injury, raised liver enzymes, low platelets, birth weight, and neonatal seizures, consensus definitions were developed specifically for low- and middle-income countries because of the limited availability of diagnostic interventions including computerised tomography, chest x-ray, laboratory tests, equipment, and electroencephalogram monitoring. CONCLUSIONS: Consensus on measurements for the pre-eclampsia core outcome set will help to ensure consistency across future randomised trials and systematic reviews. Such standardization should make research evidence more accessible and facilitate the translation of research into clinical practice. Video abstract can be available at: www.dropbox.com/s/ftrgvrfu0u9glqd/6.%20Standardising%20definitions%20in%20teh%20pre-eclampsia%20core%20outcome%20set%3A%20a%20consensus%20development%20study.mp4?dl=0.
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Journal articleModi N, 2020,
Improving the Efficiency and Impact of Clinical Research: A Game Changer for 21st Century Neonatology
, NEONATOLOGY, Vol: 117, Pages: 207-210, ISSN: 1661-7800 -
Journal articleDuffy JMN, Cairns AE, Richards-Doran D, et al., 2020,
A core outcome set for pre-eclampsia research: An international consensus development study
, BJOG: an International Journal of Obstetrics and Gynaecology, Vol: 127, Pages: 1516-1526, ISSN: 1470-0328OBJECTIVE: To develop a core outcome set for pre-eclampsia. DESIGN: Consensus development study. SETTING: International. POPULATION: Two hundred and eight one healthcare professionals, 41 researchers, and 110 patients, representing 56 countries, participated METHODS: Modified Delphi method and Modified Nominal Group Technique. RESULTS: A longlist of 116 potential core outcomes was developed, by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting. Maternal core outcomes: death, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary oedema, acute kidney injury, liver haematoma or rupture, abruption, postpartum haemorrhage, raised liver enzymes, low platelets, admission to intensive care required, and intubation and ventilation. Offspring core outcomes: stillbirth, gestational age at delivery, birth weight, small-for-gestational-age, neonatal mortality, seizures, admission to neonatal unit required, and respiratory support. CONCLUSIONS: The core outcome set for pre-eclampsia should underpin future randomised trials and systematic reviews. Such implementation should ensure future research holds the necessary reach and relevance to inform clinical practice, enhance women's care, and improve the outcomes of pregnant women and their babies.
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Journal articleWebbe J, Duffy JMN, Afonso E, et al., 2020,
Core outcomes in neonatology: Development of a core outcome set for neonatal research
, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 105, Pages: 425-431, ISSN: 1359-2998BackgroundNeonatal research evaluates many different outcomes using multiple measures. This canprevent synthesis of trial results in meta-analyses and selected outcomes may not berelevant to former patients, parents and health professionals.ObjectiveTo define a core outcome set (COS) for research involving infants receiving neonatal care ina high income setting.DesignOutcomes reported in neonatal trials and qualitative studies were systematically reviewed.Stakeholders were recruited for a three-round international Delphi survey. A consensusmeeting was held to confirm the final COS, based upon the survey results.ParticipantsFour hundred and fourteen former patients, parents, healthcare professionals andresearchers took part in the eDelphi survey; 173 completed all 3 rounds. Sixteenstakeholders participated in the consensus meeting.ResultsThe literature reviews identified 104 outcomes; these were included in round one.Participants proposed ten additional outcomes; 114 outcomes were scored in round two andthree. Round one scores showed different stakeholder groups prioritised contrastingoutcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotisingenterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability,quality of life, adverse events, visual impairment/blindness, hearing impairment /deafness,retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.6Conclusions and relevanceA COS for clinical trials and other research studies involving infants receiving neonatal carein a high-income setting has been identified. This COS for neonatology will help standardiseoutcome selection in clinical trials and ensure these are relevant to those most affected byneonatal care.
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