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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,
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
Enteral feeding: A common dilemma
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
NEC Surveillance: Practical challenges
Observational studies: A novel approach
The Challenges
Low incidence and small sample sizes
What is needed Collaboration
Variations in use of case-definitions
Retrospectively collected data
Paucity of population-based data
Prospectively collected routine data
Population-based incidence and systematic surveillance
An evidence-based case-definition
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
Aims
1) To determine the population incidence of NEC in England
2) 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
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
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”
Abdominal x-ray performed ad-hoc form
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
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 milk4) 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 formula8) Nil by mouth
Daily feeding data: Time of first feed , Type, Volume
Summary
Population-based data
Integrating clinical and research processes
UKNC-NEC study – a stepping stone for
future collaborative studies
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