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Outcomes at 7 years for babies who developed neonatal necrotising enterocolitis: the ORACLE Children Study
  1. Katie Pike1,
  2. Peter Brocklehurst2,
  3. David Jones3,
  4. Sarah Kenyon4,
  5. Alison Salt5,
  6. David Taylor6,
  7. Neil Marlow2
  1. 1Bristol Heart Institute, University of Bristol, Bristol, UK
  2. 2Institute for Women's Health, University College London, London, UK
  3. 3Health Sciences Department, University of Leicester, Leicester, UK
  4. 4School of Health and Population Sciences, University of Birmingham, Birmingham, UK
  5. 5Great Ormond Hospital for Sick Children and Institute of Child Health, University College London, London, UK
  6. 6Maternal and Newborn Health Initiative, International Federation of Gynaecology and Obstetrics, London, UK
  1. Correspondence to Neil Marlow, Institute for Women's Health, UCL Institute for Women's Health, 74 Huntley Street, London WC1E 6AU, UK; n.marlow{at}


Background Within the ORACLE Children Study Cohort, the authors have evaluated long-term consequences of the diagnosis of confirmed or suspected neonatal necrotising enterocolitis (NEC) at age of 7 years.

Methods Outcomes were assessed using a parental questionnaire, including the Health Utilities Index (HUI-3) to assess functional impairment, and specific medical and behavioural outcomes. Educational outcomes for children in England were explored using national standardised tests. Multiple logistic regression was used to explore independent associates of NEC within the cohort.

Results The authors obtained data for 119 (77%) of 157 children following proven or suspected NEC and compared their outcomes with those of the remaining 6496 children. NEC was associated with an increase in risk of neonatal death (OR 14.6 (95% CI 10.4 to 20.6)).

At 7 years, NEC conferred an increased risk of all grades of impairment. Adjusting for confounders, risks persisted for any HUI-3 defined functional impairment (adjusted OR 1.55 (1.05, 2.29)), particularly mild impairment (adjusted OR 1.61 (1.03, 2.53)) both in all NEC children and in those with proven NEC, which appeared to be independent. No behavioural or educational associations were confirmed. Following NEC, children were more likely to suffer bowel problems than non-NEC children (adjusted OR 3.96 (2.06, 7.61)).

Conclusions The ORACLE Children Study provided opportunity for the largest evaluation of school age outcome following neonatal NEC and demonstrates significant long-term consequences of both gut function (presence of stoma, admission for bowel problems and continuing medical care for gut-related problems) and motor, sensory and cognitive outcomes as measured using HUI-3.

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  • Funding Medical Research Council Both the ORACLE Trial and the Children Study were funded by the UK Medical Research Council (MRC) ISRCT Number 52995660 and sponsored by University Hospitals of Leicester and approved by their research and development directorate. NM receives part funding from the Department of Health's NIHR Biomedical Research Centres funding scheme at UCLH/UCL.

  • Competing interests None.

  • Ethics approval West Midlands Multi-centre Research Ethics Committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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