Publications by authors named "Cheryl Battersby"

25 Publications

  • Page 1 of 1

Early versus later initiation of parenteral nutrition for very preterm infants: a propensity score-matched observational study.

Arch Dis Child Fetal Neonatal Ed 2021 Nov 18. Epub 2021 Nov 18.

Department of Neonatal Medicine, Imperial College London, London, UK.

Objective: To evaluate the impact of timing of initiation of parenteral nutrition (PN) after birth in very preterm infants.

Design: Propensity-matched analysis of data from the UK National Neonatal Research Database.

Patients: 65 033 babies <31 weeks gestation admitted to neonatal units in England and Wales between 2008 and 2019.

Interventions: PN initiated in the first 2 days (early) versus after the second postnatal day (late). Babies who died in the first 2 days without receiving PN were analysed as 'late'.

Main Outcome Measures: The main outcome measure was morbidity-free survival to discharge. The secondary outcomes were survival to discharge, growth and other core neonatal outcomes.

Findings: No difference was found in the primary outcome (absolute rate difference (ARD) between early and late 0.50%, 95% CI -0.45 to 1.45, p=0.29). The early group had higher rates of survival to discharge (ARD 3.3%, 95% CI 2.7 to 3.8, p<0.001), late-onset sepsis (ARD 0.84%, 95% CI 0.48 to 1.2, p<0.001), bronchopulmonary dysplasia (ARD 1.24%, 95% CI 0.30 to 2.17, p=0.01), treated retinopathy of prematurity (ARD 0.50%, 95% CI 0.17 to 0.84, p<0.001), surgical procedures (ARD 0.80%, 95% CI 0.20 to 1.40, p=0.01) and greater drop in weight z-score between birth and discharge (absolute difference 0.019, 95% CI 0.003 to 0.035, p=0.02). Of 4.9% of babies who died in the first 2 days, 3.4% were in the late group and not exposed to PN.

Conclusions: Residual confounding and survival bias cannot be excluded and justify the need for a randomised controlled trial powered to detect differences in important functional outcomes.
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http://dx.doi.org/10.1136/archdischild-2021-322383DOI Listing
November 2021

Changes in neonatal admissions, care processes and outcomes in England and Wales during the COVID-19 pandemic: a whole population cohort study.

BMJ Open 2021 10 1;11(10):e054410. Epub 2021 Oct 1.

Section of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK

Objectives: The COVID-19 pandemic instigated multiple societal and healthcare interventions with potential to affect perinatal practice. We evaluated population-level changes in preterm and full-term admissions to neonatal units, care processes and outcomes.

Design: Observational cohort study using the UK National Neonatal Research Database.

Setting: England and Wales.

Participants: Admissions to National Health Service neonatal units from 2012 to 2020.

Main Outcome Measures: Admissions by gestational age, ethnicity and Index of Multiple Deprivation, and key care processes and outcomes.

Methods: We calculated differences in numbers and rates between April and June 2020 (spring), the first 3 months of national lockdown (COVID-19 period), and December 2019-February 2020 (winter), prior to introduction of mitigation measures, and compared them with the corresponding differences in the previous 7 years. We considered the COVID-19 period highly unusual if the spring-winter difference was smaller or larger than all previous corresponding differences, and calculated the level of confidence in this conclusion.

Results: Marked fluctuations occurred in all measures over the 8 years with several highly unusual changes during the COVID-19 period. Total admissions fell, having risen over all previous years (COVID-19 difference: -1492; previous 7-year difference range: +100, +1617; p<0.001); full-term black admissions rose (+66; -64, +35; p<0.001) whereas Asian (-137; -14, +101; p<0.001) and white (-319; -235, +643: p<0.001) admissions fell. Transfers to higher and lower designation neonatal units increased (+129; -4, +88; p<0.001) and decreased (-47; -25, +12; p<0.001), respectively. Total preterm admissions decreased (-350; -26, +479; p<0.001). The fall in extremely preterm admissions was most marked in the two lowest socioeconomic quintiles.

Conclusions: Our findings indicate substantial changes occurred in care pathways and clinical thresholds, with disproportionate effects on black ethnic groups, during the immediate COVID-19 period, and raise the intriguing possibility that non-healthcare interventions may reduce extremely preterm births.
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http://dx.doi.org/10.1136/bmjopen-2021-054410DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8488283PMC
October 2021

Outcomes in relation to early parenteral nutrition use in preterm neonates born between 30 and 33 weeks' gestation: a propensity score matched observational study.

Arch Dis Child Fetal Neonatal Ed 2021 Sep 21. Epub 2021 Sep 21.

Neonatal Medicine, Imperial College London, London, UK.

Objective: To evaluate whether in preterm neonates parenteral nutrition use in the first 7 postnatal days, compared with no parenteral nutrition use, is associated with differences in survival and other important morbidities. Randomised trials in critically ill older children show that harms, such as nosocomial infection, outweigh benefits of early parenteral nutrition administration; there is a paucity of similar data in neonates.

Design: Retrospective cohort study using propensity matching including 35 maternal, infant and organisational factors to minimise bias and confounding.

Setting: National, population-level clinical data obtained for all National Health Service neonatal units in England and Wales.

Patients: Preterm neonates born between 30 and 32 weeks.

Interventions: The exposure was parenteral nutrition administered in the first 7 days of postnatal life; the comparator was no parenteral nutrition.

Main Outcome Measures: The primary outcome was survival to discharge from neonatal care. Secondary outcomes comprised the neonatal core outcome set.

Results: 16 292 neonates were compared in propensity score matched analyses. Compared with 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 of necrotising enterocolitis (absolute rate increase 4.6%), bronchopulmonary dysplasia (absolute rate increase 3.9%), late-onset sepsis (absolute rate increase 1.5%) and need for surgical procedures (absolute rate increase 0.92%).

Conclusions: In neonates born between 30 and 32 weeks' gestation, those given parenteral nutrition in the first postnatal week had a higher rate of survival but higher rates of important neonatal morbidities. Clinician equipoise in this area should be resolved by prospective randomised trials.

Trial Registration Number: NCT03767634.
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http://dx.doi.org/10.1136/archdischild-2021-321643DOI Listing
September 2021

Comparison of NICE Guideline CG149 and the Sepsis Risk Calculator for the Management of Early-Onset Sepsis on the Postnatal Ward.

Neonatology 2021 9;118(5):562-568. Epub 2021 Sep 9.

Imperial College London, London, United Kingdom.

Introduction: The NICE guideline CG149 has increased the number of well infants receiving antibiotics for suspected early-onset sepsis (EOS). The Kaiser Permanente sepsis risk calculator (SRC) has safely and dramatically reduced investigations and antibiotics for suspected EOS in the USA. This study evaluates the current management of suspected EOS against the NICE guideline CG149 and the SRC.

Methods: This study is a prospective, multicentre, observational study across 13 neonatal units in London. Infants were born between June and August 2019 at ≥34 weeks gestation and commenced on antibiotics for suspected EOS and cared for on postnatal/transitional care wards. Data were prospectively recorded: risk factors, clinical indicators, investigations, and results. Outcome measures included the following: (1) incidence of EOS and (2) proportion of infants recommended for antibiotics by NICE versus theoretical application of SRC.

Results: 1,066/8,856 (12%) infants on postnatal/transitional care wards received antibiotics, 7 of whom had a positive blood culture (group B Streptococcus = 6 and Escherichia coli = 1), making the EOS incidence 0.8/1,000 infants. Six hundred one infants had data for SRC analysis, which recommended "antibiotics" or "blood culture" for 130/601 (21.6%) infants using an EOS incidence of 0.5/1,000 versus 527/601 (87.7%) if NICE was applied.

Conclusions: Currently, 12.0% of infants on postnatal/transitional care wards receive antibiotics for suspected EOS. The SRC could dramatically reduce antibiotic use, but further prospective studies are required to evaluate safety of SRC implementation.
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http://dx.doi.org/10.1159/000518059DOI Listing
November 2021

Birthweight and patterns of postnatal weight gain in very and extremely preterm babies in England and Wales, 2008-19: a cohort study.

Lancet Child Adolesc Health 2021 10 25;5(10):719-728. Epub 2021 Aug 25.

School of Public Health, Faculty of Medicine, Imperial College London, London, UK; Section of Neonatal Medicine, Chelsea and Westminster Hospital, London, UK. Electronic address:

Background: Intrauterine and postnatal weight are widely regarded as biomarkers of fetal and neonatal wellbeing, but optimal weight gain following preterm birth is unknown. We aimed to describe changes over time in birthweight and postnatal weight gain in very and extremely preterm babies, in relation to major morbidity and healthy survival.

Methods: In this cohort study, we used whole-population data from the UK National Neonatal Research Database for infants below 32 weeks gestation admitted to neonatal units in England and Wales between Jan 1, 2008, and Dec 31, 2019. We used non-linear Gaussian process to estimate monthly trends, and Bayesian multilevel regression to estimate unadjusted and adjusted coefficients. We evaluated birthweight; weight change from birth to 14 days; weight at 36 weeks postmenstrual age; associated Z scores; and longitudinal weights for babies surviving to 36 weeks postmenstrual age with and without major morbidities. We adjusted birthweight for antenatal, perinatal, and demographic variables. We additionally adjusted change in weight at 14 days and weight at 36 weeks postmenstrual age, and their Z scores, for postnatal variables.

Findings: The cohort comprised 90 817 infants. Over the 12-year period, mean differences adjusted for antenatal, perinatal, demographic, and postnatal variables were 0 g (95% compatibility interval -7 to 7) for birthweight (-0·01 [-0·05 to 0·03] for change in associated Z score); 39 g (26 to 51) for change in weight from birth to 14 days (0·14 [0·08 to 0·19] for change in associated Z score); and 105 g (81 to 128) for weight at 36 weeks postmenstrual age (0·27 [0·21 to 0·33] for change in associated Z score). Greater weight at 36 weeks postmenstrual age was robust to additional adjustment for enteral nutritional intake. In babies surviving without major morbidity, weight velocity in all gestational age groups stabilised at around 34 weeks postmenstrual age at 16-25 g per day along parallel percentile lines.

Interpretation: The birthweight of very and extremely preterm babies has remained stable over 12 years. Early postnatal weight loss has decreased, and subsequent weight gain has increased, but weight at 36 weeks postmenstrual age is consistently below birth percentile. In babies without major morbidity, weight velocity follows a consistent trajectory, offering opportunity to construct novel preterm growth curves despite lack of knowledge of optimal postnatal weight gain.

Funding: UK Medical Research Council.
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http://dx.doi.org/10.1016/S2352-4642(21)00232-7DOI Listing
October 2021

Timing of neonatal stoma closure: a survey of health professional perspectives and current practice.

Arch Dis Child Fetal Neonatal Ed 2021 Aug 19. Epub 2021 Aug 19.

Department of Paediatric and Neonatal Surgery, Royal Manchester Children's Hospital, Manchester, UK

Optimal timing for neonatal stoma closure remains unclear. In this study, we aimed to establish current practice and illustrate multidisciplinary perspectives on timing of stoma closure using an online survey sent to all 27 UK neonatal surgical units, as part of a research programme to determine the feasibility of a clinical trial comparing 'early' and 'late' stoma closure. 166 responses from all 27 units demonstrated concordance of opinion in target time for closure (6 weeks most commonly stated across scenarios), although there was a high variability in practice. A sizeable proportion (41%) of respondents use weight, rather than time, to determine when to close a neonatal stoma. Thematic analysis of free text responses identified nine key themes influencing decision-making; most related to nutrition, growth and stoma complications. These data provide an overview of current practice that is critical to informing an acceptable trial design.
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http://dx.doi.org/10.1136/archdischild-2021-322040DOI Listing
August 2021

Incorporating parent, former patient and clinician perspectives in the design of a national UK double-cluster, randomised controlled trial addressing uncertainties in preterm nutrition.

BMJ Paediatr Open 2021 15;5(1):e001112. Epub 2021 Jun 15.

Section of Neonatal Medicine, Imperial College London, London, UK.

Background: Comparative effectiveness randomised controlled trials are powerful tools to resolve uncertainties in existing treatments and care processes. We sought parent and patient perspectives on the design of a planned national, double-cluster randomised controlled trial (COLLABORATE) to resolve two longstanding uncertainties in preterm nutrition.

Methods: We used qualitative focus groups and interviews with parents, former patients and clinicians. We followed the Consolidated Criteria for Reporting Qualitative Research checklist and conducted framework analysis, a specific methodology within thematic analysis.

Results: We identified support for the trial's methodology and vision, and elicited themes illustrating parents' emotional needs in relation to clinical research. These were: relieving the pressure on mothers to breastfeed; opt-out consent as reducing parent stress; the desire for research to be a partnership between clinicians, parents and researchers; the value of presenting trial information in a collaborative tone; and in a format that allows assimilation by parents at their own pace. We identified anxiety and cognitive dissonance among some clinicians in which they recognised the uncertainties that justify the trial but felt unable to participate because of their strongly held views.

Conclusions: The early involvement of parents and former patients identified the centrality of parents' emotional needs in the design of comparative effectiveness research. These insights have been incorporated into trial enrolment processes and information provided to participants. Specific outputs were a two-sided leaflet providing very brief as well as more detailed information, and use of language that parents perceive as inclusive and participatory. Further work is warranted to support clinicians to address personal biases that inhibit trial participation.
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http://dx.doi.org/10.1136/bmjpo-2021-001112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8208018PMC
June 2021

Nutritional management in newborn babies receiving therapeutic hypothermia: two retrospective observational studies using propensity score matching.

Health Technol Assess 2021 06;25(36):1-106

Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.

Background: Therapeutic hypothermia is standard of care for babies with moderate to severe hypoxic-ischaemic encephalopathy. There is limited evidence to inform provision of nutrition during hypothermia.

Objectives: To assess the association during therapeutic hypothermia between (1) enteral feeding and outcomes, such as necrotising enterocolitis and (2) parenteral nutrition and outcomes, such as late-onset bloodstream infection.

Design: A retrospective cohort study using data held in the National Neonatal Research Database and applying propensity score methodology to form matched groups for analysis.

Setting: NHS neonatal units in England, Wales and Scotland.

Participants: Babies born at ≥ 36 gestational weeks between 1 January 2010 and 31 December 2017 who received therapeutic hypothermia for 72 hours or who died during treatment.

Interventions: Enteral feeding analysis - babies who were enterally fed during therapeutic hypothermia (intervention) compared with babies who received no enteral feeds during therapeutic hypothermia (control). Parenteral nutrition analysis - babies who received parenteral nutrition during therapeutic hypothermia (intervention) compared with babies who received no parenteral nutrition during therapeutic hypothermia (control).

Outcome Measures: Primary outcomes were severe and pragmatically defined necrotising enterocolitis (enteral feeding analysis) and late-onset bloodstream infection (parenteral nutrition analysis). Secondary outcomes were survival at neonatal discharge, length of neonatal stay, breastfeeding at discharge, onset of breastfeeding, time to first maternal breast milk, hypoglycaemia, number of days with a central line in situ, duration of parenteral nutrition, time to full enteral feeds and growth.

Results: A total of 6030 babies received therapeutic hypothermia. Thirty-one per cent of babies received enteral feeds and 25% received parenteral nutrition. Seven babies (0.1%) were diagnosed with severe necrotising enterocolitis, and further comparative analyses were not conducted on this outcome. A total of 3236 babies were included in the matched enteral feeding analysis. Pragmatically defined necrotising enterocolitis was rare in both groups (0.5% vs. 1.1%) and was lower in babies who were fed during hypothermia (rate difference -0.5%, 95% confidence interval -1.0% to -0.1%;  = 0.03). Higher survival to discharge (96.0% vs. 90.8%, rate difference 5.2%, 95% confidence interval 3.9% to 6.6%;  < 0.001) and higher breastfeeding at discharge (54.6% vs. 46.7%, rate difference 8.0%, 95% confidence interval 5.1% to 10.8%;  < 0.001) rates were observed in enterally fed babies who also had a shorter neonatal stay (mean difference -2.2 days, 95% confidence interval -3.0 to -1.2 days). A total of 2480 babies were included in the matched parenteral nutrition analysis. Higher levels of late-onset bloodstream infection were seen in babies who received parenteral nutrition (0.3% vs. 0.9%, rate difference 0.6%, 95% confidence interval 0.1% to 1.2%;  = 0.03). Survival was lower in babies who did not receive parenteral nutrition (90.0% vs. 93.1%, rate difference 3.1%, 95% confidence interval 1.5% to 4.7%;  < 0.001).

Limitations: Propensity score methodology can address imbalances in observed confounders only. Residual confounding by unmeasured or poorly recorded variables cannot be ruled out. We did not analyse by type or volume of enteral or parenteral nutrition.

Conclusions: Necrotising enterocolitis is rare in babies receiving therapeutic hypothermia, and the introduction of enteral feeding is associated with a lower risk of pragmatically defined necrotising enterocolitis and other beneficial outcomes, including rates of higher survival and breastfeeding at discharge. Receipt of parenteral nutrition during therapeutic hypothermia is associated with a higher rate of late-onset infection but lower mortality. These results support introduction of enteral feeding during therapeutic hypothermia.

Future Work: Randomised trials to assess parenteral nutrition during therapeutic hypothermia.

Trial Registration: Current Controlled Trials ISRCTN474042962.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 36. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25360DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8215569PMC
June 2021

Administration of parenteral nutrition during therapeutic hypothermia: a population level observational study using routinely collected data held in the National Neonatal Research Database.

Arch Dis Child Fetal Neonatal Ed 2021 Nov 5;106(6):608-613. Epub 2021 May 5.

Division of Neonatal-Perinatal Medicine, Dalhousie University-Faculty of Medicine, Halifax, Nova Scotia, Canada.

Background: Parenteral nutrition is commonly administered during therapeutic hypothermia. Randomised trials in critically ill children indicate that parenteral nutrition may be harmful.

Objective: To examine the association between parenteral nutrition during therapeutic hypothermia and clinically important outcomes.

Design: Retrospective, population-based cohort study using the National Neonatal Research Database; propensity scores were used to create matched groups for comparison.

Setting: National Health Service neonatal units in England, Scotland and Wales.

Participants: 6030 term and near-term babies, born 1/1/2010 and 31/12/2017, who received therapeutic hypothermia; 2480 babies in the matched analysis.

Exposure: We compared babies that received any parenteral nutrition during therapeutic hypothermia with babies that did not.

Main Outcome Measures: Primary outcome: blood culture confirmed late-onset infection; secondary outcomes: treatment for late onset infection, necrotising enterocolitis, survival, length of stay, measures of breast feeding, hypoglycaemia, central line days, time to full enteral feeds, discharge weight.

Results: 1475/6030 babies (25%) received parenteral nutrition. In comparative matched analyses, the rate of culture positive late onset infection was higher in babies that received parenteral nutrition (0.3% vs 0.9%; difference 0.6; 95% CI 0.1, 1.2; p=0.03), but treatment for presumed infection was not (difference 0.8%, 95% CI -2.1 to 3.6, p=0.61). Survival was higher in babies that received parenteral nutrition (93.1% vs 90.0%; rate difference 3.1, 95% CI 1.5, 4.7; p<0.001).

Conclusions: Receipt of parenteral nutrition during therapeutic hypothermia is associated with higher late-onset infection but lower mortality. This finding may be explained by residual confounding. Research should address the risks and benefits of parenteral nutrition in this population.
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http://dx.doi.org/10.1136/archdischild-2020-321299DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8543212PMC
November 2021

Feeding during neonatal therapeutic hypothermia, assessed using routinely collected National Neonatal Research Database data: a retrospective, UK population-based cohort study.

Lancet Child Adolesc Health 2021 06 21;5(6):408-416. Epub 2021 Apr 21.

Division of Neonatal-Perinatal Medicine, Faculty of Medicine, Dalhousie University, IWK Health Centre, Halifax, NS, Canada.

Background: Therapeutic hypothermia is standard of care in high-income countries for babies born with signs of hypoxic ischaemic encephalopathy, but optimal feeding during treatment is uncertain and practice is variable. This study aimed to assess the association between feeding during therapeutic hypothermia and clinically important outcomes.

Methods: We did a population-level retrospective cohort study using the UK National Neonatal Research Database. We included all babies admitted to National Health Service neonatal units in England, Scotland, and Wales between Jan 1, 2010, and Dec 31, 2017, who received therapeutic hypothermia for 72 h or died during this period. For analysis, we created matched groups using propensity scores and compared outcomes in babies who were fed versus unfed enterally during therapeutic hypothermia. The primary outcome was severe necrotising enterocolitis, either confirmed at surgery or causing death. Secondary outcomes include pragmatically defined necrotising enterocolitis (a recorded diagnosis of necrotising enterocolitis in babies who received at least 5 consecutive days of antibiotics while also nil by mouth during their neonatal unit stay), late-onset infection (pragmatically defined as 5 consecutive days of antibiotic treatment commencing after day 3), survival to discharge, measures of breastmilk feeding, and length of stay in neonatal unit.

Findings: 6030 babies received therapeutic hypothermia, of whom 1873 (31·1%) were fed during treatment. Seven (0·1%) babies were diagnosed with severe necrotising enterocolitis and the number was too small for further analyses. We selected 3236 (53·7%) babies for the matched feeding analysis (1618 pairs), achieving a good balance for all recorded background variables. Pragmatically defined necrotising enterocolitis was rare in both groups (incidence 0·5%, 95% CI 0·2-0·9] in the fed group vs 1·1% [0·7-1·4] in the unfed group). The enterally fed group had fewer pragmatically defined late-onset infections (difference -11·6% [95% CI -14·0 to -9·3]; p<0·0001), higher survival to discharge (5·2% [3·9-6·6]; p<0·0001), higher proportion of breastfeeding at discharge (8·0% [5·1-10·8]; p<0·0001), and shorter neonatal unit stays (-2·2 [-3·0 to -1·2] days; p<0·0001) compared with the unfed group.

Interpretation: Necrotising enterocolitis is rare in babies receiving therapeutic hypothermia. Enteral feeding during hypothermia is safe and associated with beneficial outcomes compared with not feeding, although residual confounding could not be completely ruled out. Our findings support starting milk feeds during therapeutic hypothermia.

Funding: UK National Institute for Health Research Health Technology Assessment programme 16/79/13.
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http://dx.doi.org/10.1016/S2352-4642(21)00026-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8131202PMC
June 2021

Identification of variation in nutritional practice in neonatal units in England and association with clinical outcomes using agnostic machine learning.

Sci Rep 2021 03 30;11(1):7178. Epub 2021 Mar 30.

NIHR Imperial Biomedical Research Centre, ITMAT Data Science Group, Imperial College London, London, UK.

We used agnostic, unsupervised machine learning to cluster a large clinical database of information on infants admitted to neonatal units in England. Our aim was to obtain insights into nutritional practice, an area of central importance in newborn care, utilising the UK National Neonatal Research Database (NNRD). We performed clustering on time-series data of daily nutritional intakes for very preterm infants born at a gestational age less than 32 weeks (n = 45,679) over a six-year period. This revealed 46 nutritional clusters heterogeneous in size, showing common interpretable clinical practices alongside rarer approaches. Nutritional clusters with similar admission profiles revealed associations between nutritional practice, geographical location and outcomes. We show how nutritional subgroups may be regarded as distinct interventions and tested for associations with measurable outcomes. We illustrate the potential for identifying relationships between nutritional practice and outcomes with two examples, discharge weight and bronchopulmonary dysplasia (BPD). We identify the well-known effect of formula milk on greater discharge weight as well as support for the plausible, but insufficiently evidenced view that human milk is protective against BPD. Our framework highlights the potential of agnostic machine learning approaches to deliver clinical practice insights and generate hypotheses using routine data.
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http://dx.doi.org/10.1038/s41598-021-85878-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8009880PMC
March 2021

Increase in the use of inhaled nitric oxide in neonatal intensive care units in England: a retrospective population study.

BMJ Paediatr Open 2021 22;5(1):e000897. Epub 2021 Feb 22.

Neonatal Medicine, Imperial College London Faculty of Medicine, London, UK.

Objective: To describe temporal changes in inhaled nitric oxide (iNO) use in English neonatal units between 2010 and 2015.

Design: Retrospective analysis using data extracted from the National Neonatal Research Database.

Setting: All National Health Service neonatal units in England.

Patients: Infants of all gestational ages born 2010-2015 admitted to a neonatal unit and received intensive care.

Main Outcome Measures: Proportion of infants who received iNO; age at initiation and duration of iNO use.

Results: 4.9% (6346/129 883) of infants received iNO; 31% (1959/6346) were born <29 weeks, 18% (1152/6346) 29-33 weeks and 51% (3235/6346)>34 weeks of gestation. Between epoch 1 (2010-2011) and epoch 3 (2014-2015), there was (1) an increase in the proportion of infants receiving iNO: <29 weeks (4.9% vs 15.9%); 29-33 weeks (1.1% vs 4.8%); >34 weeks (4.5% vs 5.0%), (2) increase in postnatal age at iNO initiation: <29 weeks 10 days vs 18 days; 29-33 weeks 2 days vs 10 days, (iii) reduction in iNO duration: <29 weeks (3 days vs 2 days); 29-33 weeks (2 days vs 1 day).

Conclusions: Between 2010 and 2015, there was an increase in the use of iNO among infants admitted to English neonatal units. This was most notable among the most premature infants with an almost fourfold increase. Given the cost of iNO therapy, limited evidence of efficacy in preterm infants and potential for harm, we suggest that exposure to iNO should be limited, ideally to infants included in research studies (either observational or randomised placebo-controlled trial) or within a protocolised pathway. Development of consensus guidelines may also help standardise practice.
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http://dx.doi.org/10.1136/bmjpo-2020-000897DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903123PMC
February 2021

Changing clinical characteristics of infants treated for hypoxic-ischaemic encephalopathy in England, Wales and Scotland: a population-based study using the National Neonatal Research Database.

Arch Dis Child Fetal Neonatal Ed 2021 Sep 4;106(5):501-508. Epub 2021 Feb 4.

Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London Faculty of Medicine, London, UK

Background: Therapeutic hypothermia is standard of care for babies with moderate/severe hypoxic-ischaemic encephalopathy and is increasingly used for mild encephalopathy.

Objective: Describe temporal trends in the clinical condition of babies diagnosed with hypoxic-ischaemic encephalopathy who received therapeutic hypothermia.

Design: Retrospective cohort study using data held in the National Neonatal Research Database.

Setting: National Health Service neonatal units in England, Wales and Scotland.

Patients: Infants born from 1 January 2010 to 31 December 2017 with a recorded diagnosis of hypoxic-ischaemic encephalopathy who received therapeutic hypothermia for at least 3 days or died in this period.

Main Outcomes: Primary outcomes: recorded clinical characteristics including umbilical cord pH; Apgar score; newborn resuscitation; seizures and treatment on day 1.

Secondary Outcomes: recorded hypoxic-ischaemic encephalopathy grade.

Results: 5201 babies with a diagnosis of hypoxic-ischaemic encephalopathy received therapeutic hypothermia or died; annual numbers increased over the study period. A decreasing proportion had clinical characteristics of severe hypoxia ischaemia or a diagnosis of moderate or severe hypoxic-ischaemic encephalopathy, trends were statistically significant and consistent across multiple clinical characteristics used as markers of severity.

Conclusions: Treatment with therapeutic hypothermia for hypoxic-ischaemic encephalopathy has increased in England, Scotland and Wales. An increasing proportion of treated infants have a diagnosis of mild hypoxic-ischaemic encephalopathy or have less severe clinical markers of hypoxia. This highlights the importance of determining the role of hypothermia in mild hypoxic-ischaemic encephalopathy. Receipt of therapeutic hypothermia is unlikely to be a useful marker for assessing changes in the incidence of brain injury over time.
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http://dx.doi.org/10.1136/archdischild-2020-319685DOI Listing
September 2021

Review of guidelines and recommendations from 17 countries highlights the challenges that clinicians face caring for neonates born to mothers with COVID-19.

Acta Paediatr 2020 Nov 20;109(11):2192-2207. Epub 2020 Aug 20.

Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Aim: This review examined how applicable national and regional clinical practice guidelines and recommendations for managing neonates born to mothers with COVID-19 mothers were to the evolving pandemic.

Methods: A systematic search and review identified 20 guidelines and recommendations that had been published by May 25, 2020. We analysed documents from 17 countries: Australia, Brazil, Canada, China, France, India, Italy, Japan, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, the UK and the United States.

Results: The documents were based on expert consensus with limited evidence and were of variable, low methodological rigour. Most did not provide recommendations for delivery methods or managing symptomatic infants. None provided recommendations for post-discharge assimilation of potentially infected infants into the community. The majority encouraged keeping mothers and infants together, subject to infection control measures, but one-third recommended separation. Although breastfeeding or using breastmilk was widely encouraged, two countries specifically prohibited this.

Conclusion: The guidelines and recommendations for managing infants affected by COVID-19 were of low, variable quality and may be unsustainable. It is important that transmission risks are not increased when new information is incorporated into clinical recommendations. Practice guidelines should emphasise the extent of uncertainty and clearly define gaps in the evidence.
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http://dx.doi.org/10.1111/apa.15495DOI Listing
November 2020

Challenges in Advancing Necrotizing Enterocolitis Research.

Clin Perinatol 2019 03 12;46(1):19-27. Epub 2018 Dec 12.

Section of Neonatal Medicine, Department of Medicine, Chelsea and Westminster Hospital campus, 369 Fulham Road, London SW10 9NH. Electronic address:

Progressing necrotizing enterocolitis research is difficult because the disease is variable in presentation, there are difficulties in making a precise diagnosis, a reliable agreed case-definition is currently lacking, and there is a paucity of preclinical research to identify etiologic targets. The major challenges of the cost of clinical trials and need for long-term outcome ascertainment could be eased through incorporation of novel randomization approaches and data collection into routine care, and collaboration between public-sector and industry funders.
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http://dx.doi.org/10.1016/j.clp.2018.10.002DOI Listing
March 2019

Study protocol: optimising newborn nutrition during and after neonatal therapeutic hypothermia in the United Kingdom: observational study of routinely collected data using propensity matching.

BMJ Open 2018 10 23;8(10):e026739. Epub 2018 Oct 23.

Neonatal Data Analysis Unit, Department of Medicine, Section of Neonatal Medicine, Imperial College London, London, UK.

Introduction: Therapeutic hypothermia is standard of care for infants born ≥36 weeks gestation with hypoxic ischaemic encephalopathy (HIE); consensus on optimum nutrition during therapeutic hypothermia is lacking. This results in variation in enteral feeding and parenteral nutrition (PN) for these infants. In this study, we aim to determine the optimum enteral nutrition and PN strategy for newborns with HIE during therapeutic hypothermia.

Methods And Analysis: We will undertake a retrospective cohort study using routinely recorded electronic patient data held on the United Kingdom (UK) National Neonatal Research Database (NNRD). We will extract data from infants born ≥36 weeks gestational age between 1 January 2008 and 31 December 2016, who received therapeutic hypothermia for at least 72 hours or died during therapeutic hypothermia, in neonatal units in England, Wales and Scotland. We will form matched groups in order to perform two comparisons examining: (1) the risk of NEC between infants enterally fed and infants not enterally fed, during therapeutic hypothermia; (2) the risk of late-onset blood stream infections between infants who received intravenous dextrose without any PN and infants who received PN, during therapeutic hypothermia. The following secondary outcomes will also be examined: survival, length of stay, breast feeding at discharge, hypoglycaemia, time to full enteral feeds and growth. Comparison groups will be matched on demographic, maternal, infant and organisational factors using propensity score matching.

Ethics And Dissemination: In this study, we will use deidentifed data held in the NNRD, an established national population database; parents can opt out of their baby's data being held in the NNRD. This study holds study-specific Research Ethics Committee approval (East Midlands Leicester Central, 17/EM/0307). These results will help inform optimum nutritional management in infants with HIE receiving therapeutic hypothermia; results will be disseminated through conferences, scientific publications and parent-centred information produced in partnership with parents.

Trial Registration Number: NCT03278847; pre-results, ISRCTN47404296; pre-results.
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http://dx.doi.org/10.1136/bmjopen-2018-026739DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6224768PMC
October 2018

Optimising nutrition during therapeutic hypothermia.

Arch Dis Child Fetal Neonatal Ed 2019 May 15;104(3):F230-F231. Epub 2018 Oct 15.

Section of Neonatal Medicine, Department of Medicine, Imperial College London, London, UK.

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http://dx.doi.org/10.1136/archdischild-2018-315393DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6764248PMC
May 2019

The United Kingdom National Neonatal Research Database: A validation study.

PLoS One 2018 16;13(8):e0201815. Epub 2018 Aug 16.

Barts and the London School of Medicine and Dentistry, London, United Kingdom.

Background: The National Neonatal Research Database (NNRD) is a rich repository of pre-defined clinical data extracted at regular intervals from point-of-care, clinician-entered electronic patient records on all admissions to National Health Service neonatal units in England, Wales, and Scotland. We describe population coverage for England and assess data completeness and accuracy.

Methods: We determined population coverage of the NNRD in 2008-2014 through comparison with data on live births in England from the Office for National Statistics. We determined the completeness of seven data items on the NNRD. We assessed the accuracy of 44 data items (16 patient characteristics, 17 processes, 11 clinical outcomes) for infants enrolled in the multi-centre randomised controlled trial, Probiotics in Preterm Study (PiPs). We compared NNRD to PiPs data, the gold standard, and calculated discordancy rates using predefined criteria, and sensitivity, specificity and positive predictive values (PPV) of binary outcomes.

Results: The NNRD holds complete population data for England for infants born alive from 25+0 to 31+6 (completed weeks) of gestation; and 70% and 90% for those born at 23 and 24 weeks respectively. Completeness of patient characteristics was over 90%. Data were linked for 2257 episodes of care received by 1258 of the 1310 babies recruited to PiPs. Discordancy rates were <5% for 13/16 patient characteristics (exceptions: mode of delivery 8.7%; maternal ethnicity 10.2%, Lower layer Super Output Area 16.5%); <5% for 9/16 processes (exceptions: medical treatment for Patent ductus arteriosus 6.1%, high-dependency days 10.2%, central line days 11.2%, type of first milk 22.3%; and during first 14 days, summary of types of milk 13.8%; number of days of antibiotics 9.0%; whether antacid given 5.1%); and <5% for 10/11 clinical outcomes (exception: Bronchopulmonary dysplasia, defined as oxygen dependency at 36 weeks postmenstrual age 3.3%). The specificity of NNRD data was >85% for all outcomes; sensitivity ranged from 50-100%; PPV ranged from 58.8 (95% CI 40.8-75.4%) for porencephalic cyst to 99.7 (95% CI 99.2, 99.9%) for survival to discharge.

Conclusions: The completeness and quality of data held in the NNRD is high, providing assurance in relation to use for multiple purposes, including national audit, health service evaluations, quality improvement, and research.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0201815PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6095506PMC
February 2019

Incidence of neonatal necrotising enterocolitis in high-income countries: a systematic review.

Arch Dis Child Fetal Neonatal Ed 2018 Mar 9;103(2):F182-F189. Epub 2018 Jan 9.

Department of Medicine, Neonatal Data Analysis Unit, Section of Neonatal Medicine, Chelsea and Westminster campus, Imperial College London, London, UK.

Objective: To conduct a systematic review of neonatal necrotising enterocolitis (NEC) rates in high-income countries published in peer-reviewed journals.

Methods: We searched MEDLINE, Embase and PubMed databases for observational studies published in peer-reviewed journals. We selected studies reporting national, regional or multicentre rates of NEC in 34 Organisation for Economic Co-operation and Development countries. Two investigators independently screened studies against predetermined criteria. For included studies, we extracted country, year of publication in peer-reviewed journal, study time period, study population inclusion and exclusion criteria, case definition, gestation or birth weight-specific NEC and mortality rates.

Results: Of the 1888 references identified, 120 full manuscripts were reviewed, 33 studies met inclusion criteria, 14 studies with the most recent data from 12 countries were included in the final analysis. We identified an almost fourfold difference, from 2% to 7%, in the rate of NEC among babies born <32 weeks' gestation and an almost fivefold difference, from 5% to 22%, among those with a birth weight <1000 g but few studies covered the entire at-risk population. The most commonly applied definition was Bell's stage ≥2, which was used in seven studies. Other definitions included Bell's stage 1-3, definitions from the Centers for Disease Control and Prevention, International Classification for Diseases and combinations of clinical and radiological signs as specified by study authors.

Conclusion: The reasons for international variation in NEC incidence are an important area for future research. Reliable inferences require clarity in defining population coverage and consistency in the case definition applied. PROSPERO INTERNATIONAL PROSPECTIVE REGISTER OF SYSTEMATIC REVIEWS REGISTRATION NUMBER: CRD42015030046.
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http://dx.doi.org/10.1136/archdischild-2017-313880DOI Listing
March 2018

Survival of very preterm infants admitted to neonatal care in England 2008-2014: time trends and regional variation.

Arch Dis Child Fetal Neonatal Ed 2018 May 7;103(3):F208-F215. Epub 2017 Sep 7.

Section of Neonatal Medicine, Department of Medicine, Imperial College London, London, UK.

Objective: To analyse survival trends and regional variation for very preterm infants admitted to neonatal care.

Setting: All neonatal units in England.

Patients: Infants born at 22-31 weeksgestational age (GA) over 2008-2014 and admitted to neonatal care; published data for admitted infants 22-25 weeks GA in 1995 and 2006, and for live births at 22-31 weeks GA in 2013.

Methods: We obtained data from the National Neonatal Research Database. We used logistic regression to model survival probability with birth weight, GA, sex, antenatal steroid exposure and multiple birth included in the risk adjustment model and calculated annualpercentage change (APC) for trends using joinpoint regression. We evaluated survival over a 20-year period for infants <26 weeks' GA using additional published data from the EPICure studies.

Results: We identified 50 112 eligible infants. There was an increase in survival over 2008-2014 (2008: 88.0%; 2014: 91.3%; adjusted APC 0.46% (95% CI 0.30 to 0.62) p<0.001). The greatest improvement was at 22-23 weeks (APC 6.03% (95% CI 2.47 to 3.53) p=0.002). Improvement largely occurred in London and South of England (APC: London 1.26% (95% CI 0.60 to 1.96); South of England 1.09% (95% CI 0.36 to 1.82); Midlands and East of England 0.15% (95% CI -0.56 to 0.86); and North of England 0.26% (95% CI -0.54 to 1.07)). Survival at the earliest gestations improved at a similar rate over 1995-2014 (22-25 weeks, APC 2.73% (95% CI 2.35 to 3.12), p value for change=0.25).

Conclusions: Continued national improvement in the survival of very preterm admissions masks important regional variation. Timely assessment of preterm survival is feasible using electronic records.
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http://dx.doi.org/10.1136/archdischild-2017-312748DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5916099PMC
May 2018

Term admissions to neonatal units in England: a role for transitional care? A retrospective cohort study.

BMJ Open 2017 05 29;7(5):e016050. Epub 2017 May 29.

Neonatal Unit, University College London Hospital, London, UK.

Objective: To identify the primary reasons for term admissions to neonatal units in England, to determine risk factors for admissions for jaundice and to estimate the proportion who can be cared for in a transitional setting without separation of mother and baby.

Design: Retrospective observational study using neonatal unit admission data from the National Neonatal Research Database and data of live births in England from the Office for National Statistics.

Setting: All 163 neonatal units in England 2011-2013.

Participants: 133 691 term babies born ≥37 weeks gestational age and admitted to neonatal units in England.

Primary And Secondary Outcomes: Primary reasons for admission, term babies admitted for the primary reason of jaundice, patient characteristics, postnatal age at admission, total length of stay, phototherapy, intravenous fluids, exchange transfusion and kernicterus.

Results: Respiratory disease was the most common reason for admission overall, although jaundice was the most common reason for admission from home (22% home vs 5% hospital). Risk factors for admission for jaundice include male, born at 37 weeks gestation, Asian ethnicity and multiple birth. The majority of babies received only a brief period of phototherapy, and only a third received intravenous fluids, suggesting that some may be appropriately managed without separation of mother and baby. Admission from home was significantly later (3.9 days) compared with those admitted from elsewhere in the hospital (1.7 days) (p<0.001).

Conclusion: Around two-thirds of term admissions for jaundice may be appropriately managed in a transitional care setting, avoiding separation of mother and baby. Babies with risk factors may benefit from a community midwife postnatal visit around the third day of life to enable early referral if necessary. We recommend further work at the national level to examine provision and barriers to transitional care, referral pathways between primary and secondary care, and community postnatal care.
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http://dx.doi.org/10.1136/bmjopen-2017-016050DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5726072PMC
May 2017

Proposed Definition of Necrotizing Enterocolitis May Be of Limited Value-Reply.

JAMA Pediatr 2017 07;171(7):711-712

Neonatal Data Analysis Unit, Imperial College, London, United Kingdom.

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http://dx.doi.org/10.1001/jamapediatrics.2017.0977DOI Listing
July 2017

Incidence and enteral feed antecedents of severe neonatal necrotising enterocolitis across neonatal networks in England, 2012-13: a whole-population surveillance study.

Lancet Gastroenterol Hepatol 2017 01 8;2(1):43-51. Epub 2016 Nov 8.

Neonatal Data Analysis Unit, Imperial College London, London, UK. Electronic address:

Background: Necrotising enterocolitis is a neonatal gastrointestinal inflammatory disease with high mortality and severe morbidity. This disorder is growing in global relevance as birth rates and survival of babies with low gestational age improve. Population data are scant and pathogenesis is incompletely understood, but enteral feed exposures are believed to affect risk. We aimed to quantify the national incidence of severe necrotising enterocolitis, describe variation across neonatal networks, and investigate enteral feeding-related antecedents of severe necrotising enterocolitis.

Methods: We undertook a 2-year national surveillance study (the UK Neonatal Collaborative Necrotising Enterocolitis [UKNC-NEC] Study) of babies born in England to quantify the burden of severe or fatal necrotising enterocolitis confirmed by laparotomy, leading to death, or both. Data on all liveborn babies admitted to neonatal units between Jan 1, 2012, and Dec 31, 2013, were obtained from the National Neonatal Research Database. In the subgroup of babies born before a gestational age of 32 weeks, we did a propensity score analysis of the effect of feeding in the first 14 postnatal days with own mother's milk, with or without human donor milk and avoidance of bovine-origin formula, or milk fortifier, on the risk of developing necrotising enterocolitis.

Findings: During the study period, 118 073 babies were admitted to 163 neonatal units across 23 networks, of whom 14 678 were born before a gestational age of 32 weeks. Overall, 531 (0·4%) babies developed severe necrotising enterocolitis, of whom 247 (46·5%) died (139 after laparotomy). 462 (3·2%) of 14 678 babies born before a gestational age of 32 weeks developed severe necrotising enterocolitis, of whom 222 (48·1%) died. Among babies born before a gestational age of 32 weeks, the adjusted network incidence of necrotising enterocolitis ranged from 2·51% (95% CI 1·13-3·60) to 3·85% (2·37-5·33), with no unusual variation from the adjusted national incidence of 3·13% (2·85-3·42), despite variation in feeding practices. The absolute risk difference for babies born before a gestational age of 32 weeks who received their own mother's milk within 7 days of birth was -0·88% (95% CI -1·15 to -0·61; relative risk 0·69, 95% CI 0·60 to 0·78; number needed to treat to prevent one case of necrotising enterocolitis 114, 95% CI 87 to 136). For babies who received no compared with any bovine-origin products within 14 days of birth, the absolute risk difference was -0·65% (-1·01 to -0·29; relative risk 0·61, 0·39 to 0·83; number needed to treat 154, 99 to 345). We were unable to assess the effect of human donor milk as use was low.

Interpretation: Early feeding of babies with their own mother's milk and avoidance of bovine-origin products might reduce the risk of necrotising enterocolitis, but the absolute reduction is small. Owing to the rarity of severe necrotising enterocolitis, international collaborations are needed for adequately powered preventive trials.

Funding: National Institute for Health Research.
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http://dx.doi.org/10.1016/S2468-1253(16)30117-0DOI Listing
January 2017

Development of a Gestational Age-Specific Case Definition for Neonatal Necrotizing Enterocolitis.

JAMA Pediatr 2017 03;171(3):256-263

Neonatal Data Analysis Unit, Imperial College London, London, England.

Importance: Necrotizing enterocolitis (NEC) is a major cause of neonatal morbidity and mortality. Preventive and therapeutic research, surveillance, and quality improvement initiatives are hindered by variations in case definitions.

Objective: To develop a gestational age (GA)-specific case definition for NEC.

Design, Setting, And Participants: We conducted a prospective 34-month population study using clinician-recorded findings from the UK National Neonatal Research Database between December 2011 and September 2014 across all 163 neonatal units in England. We split study data into model development and validation data sets and categorized GA into groups (group 1, less than 26 weeks' GA; group 2, 26 to less than 30 weeks' GA; group 3, 30 to less than 37 weeks' GA; group 4, 37 or more weeks' GA). We entered GA, birth weight z score, and clinical and abdominal radiography findings as candidate variables in a logistic regression model, performed model fitting 1000 times, averaged the predictions, and used estimates from the fitted model to develop an ordinal NEC score and cut points to develop a dichotomous case definition based on the highest area under the receiver operating characteristic curves [AUCs] and positive predictive values [PPVs].

Exposures: Abdominal radiography performed to investigate clinical concerns.

Main Outcomes And Measures: Ordinal NEC likelihood score, dichotomous case definition, and GA-specific probability plots.

Results: Of the 3866 infants, the mean (SD) birth weight was 2049.1 (1941.7) g and mean (SD) GA was 32 (5) weeks; 2032 of 3663 (55.5%) were male. The total included 2978 infants (77.0%) without NEC and 888 (23.0%) with NEC. Infants with NEC in group 1 were less likely to present with pneumatosis (31.1% vs 47.2%; P = .01), blood in stool (11.8% vs 29.6%; P < .001), or mucus in stool (2.1% vs 5.6%; P = .048) but more likely to present with gasless abdominal radiography findings (6.3% vs 0.9%; P = .009) compared with infants with NEC in group 3. In the ordinal NEC score analysis, we allocated 3 points to pneumatosis, 2 points to blood in stool, and 1 point each to abdominal tenderness and abdominal discoloration; 1 point was assigned if 1 or more of pneumoperitoneum, fixed loop, and portal venous gas were present, and 1 point was assigned if both increased and/or bilious aspirates and abdominal distension were present. The cutoff scores for the dichotomous GA-specific case definition were 2 or greater for infants in groups 1 and 2, 3 or greater for infants in group 3, and 4 or greater for infants in group 4. The ordinal NEC score and dichotomous case definition discriminated well between infants with (AUC, 87%) and without (AUC, 80%) NEC. The case definition has a sensitivity of 66.2% (95% CI, 63.0-69.4), a specificity of 94.4% (95% CI, 93.2-95.4), an AUC of 80.0% (95% CI, 79-82), and a PPV of 85.5% (95% CI, 82.6-88.1). Applying the cut points to the 431 infants who underwent a laparotomy yielded a sensitivity of 76.5% (95% CI, 70.0-82.1), a specificity of 74.4% (95% CI, 68.3-80.0), an AUC of 75.0% (95% CI, 71.0- 80.0), and a PPV of 72.9% (95% CI, 66.4-78.7).

Conclusions And Relevance: The risk of NEC and clinical presentation are associated with GA. Adoption of a consistent GA-specific case definition would strengthen global efforts to reduce the population burden of this devastating neonatal disease.
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http://dx.doi.org/10.1001/jamapediatrics.2016.3633DOI Listing
March 2017
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