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Necrotising Enterocolitis: Population approaches

Necrotising Enterocolitis: Population approaches. Cheryl Battersby Clinical Research Fellow Neonatal Data Analysis Unit. Necrotising Enterocolitis. Infant mortality in UK: Overall ↓ NEC associated ↑ ( Rees et al 2008 ) Affects up to 10% of low birth weight babies,

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Necrotising Enterocolitis: Population approaches

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  1. Necrotising Enterocolitis: Population approaches Cheryl Battersby Clinical Research Fellow Neonatal Data Analysis Unit

  2. Necrotising Enterocolitis • Infant mortality in UK: • Overall ↓ • NEC associated ↑ (Rees et al 2008) • Affects up to 10% of low birth weight babies, 30-50% mortality (Lin and Stoll 2006) • Long-term complications (Stoll et al 2004) • Limited preventive and treatment strategies • Limited knowledge of risk factors beyond low gestational age and birth weight

  3. Enteral feeding: A common dilemma

  4. First step: A population approach To provide: • A case-definition used consistently • Sample sizes needed for future studies • Current feeding practices • Baseline incidence and systematic surveillance

  5. NEC Surveillance: Practical challenges

  6. Observational studies: A novel approach The Challenges What is needed Collaboration • Low incidence and small sample sizes • An evidence-based case-definition • Variations in use of case-definitions • Paucity of population-based data • Population-based incidence and systematic surveillance • Retrospectively collected data • Prospectively collected routine data

  7. UK Neonatal Collaborative NEC STUDY • NIHR funded • Medicines for Neonates Programme • CRN portfolio adopted study • 140 (86%) neonatal units: 41 level 3, 61 level 2, 38 level 1

  8. Aims • To determine the population incidence of NEC in England • To establish an objective case-definition for NEC • 3) To identify enteral-feed related factors that precede onset of NEC in order to inform the design of future interventional randomised controlled trials

  9. Method • Analyse data collected from all babies admitted to participating neonatal units over an 18 month period • November 2011- May 2013 • Dependent on the quality of data • Interim analyses on data completeness will be performed and fed back to units

  10. Data Analysis • AIM 1: To determine the population incidence of NEC in England • Report by network using established case-definition • AIM 2: To establish an objective case-definition for NEC • Which best predicts the "gold-standard" confirmatory evidence of NEC: • “NEC on histology of resected bowel • OR visual inspection at laparotomy • OR visual inspection at post mortem examination”

  11. Abdominal x-ray performed ad-hoc form

  12. AIM 3: Enteral-feed related antecedents of NEC • Hypothesis: “There is an association between enteral-feed related factors and NEC” • Method: Comparing the outcome (NEC or no NEC) between groups of patients with different enteral-feed exposures • Statistical analysis: A selection of statistical methods to adjust for confounding factors

  13. Enteral-feed related exposures • Days (from birth) to first feed • Type of first feed (Maternal Expressed Breast Milk, Human Donor Milk, Formula) • Days to reach 120ml/kg/day • Summary measure of type of feed up to development of NEC: • 1) Exclusive maternal breast milk • 2) Maternal breast milk with breast milk fortifier • 3) Exclusive human donor milk • 4) Human donor milk with breast milk fortifier • 5) Exclusive formula • 6) Mixed human (maternal or donor) milk • 7) Mixed human (maternal or donor) milk and formula • 8) Nil by mouth

  14. Daily feeding data: Time of first feed , Type, Volume

  15. Summary • Population-based data • Integrating clinical and research processes • UKNC-NEC study – a stepping stone for future collaborative studies

  16. Acknowledgements- THANK YOU • Supervisors: Professors Neena Modi and Kate Costeloe • UKNC–NEC Study Group: All neonatal units contributing data • NDAU Team • NDAU Steering Board • Jane Abbott (BLISS) Jacquie Kemp • Prof. Peter Brocklehurst Prof. Azeem Majeed • Prof. Kate Costeloe Prof. Neena Modi • Prof. Liz Draper Prof. Andrew Wilkinson

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