COLLABORATE

• Research type

  Research Study

• Full title

  An efficient, UK-wide, real-world-data-enabled, adaptive, 2-randomisation, controlled trial to determine clinical efficacy, effect size, and safety of widely used enteral feeds in reducing necrotising enterocolitis, mortality, and cognitive impairment in preterm babies born below 29 weeks gestation

• IRAS ID

  337660

• Contact name

  Neena Modi

• Contact email

  n.modi@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  4 years, 11 months, 30 days

• Research summary

  The COLLABORATE study will address two uncertainties in the care of babies born less that 29 weeks gestation. First whether pasteurised human donor milk or preterm formula, when used to supplement insufficient availability of milk from a baby's own mother, and second whether routine versus no routine fortification of human milk feeds, affects survival to 34 weeks postmenstrual age without requiring surgery for necrotising enterocolitis. Necrotising enterocolitis is an acquired inflammation of the intestinal tract and a major cause of death and long-term impairment in preterm babies.
  We will also evaluate a range of important secondary outcomes and associated hospital costs. The study additionally includes an embedded sub-study that will use magnetic resonance imaging (MRI) and serial stool sampling to determine whether donor milk and formula have different effects on development.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  25/LO/0697

• Date of REC Opinion

  8 Oct 2025

• REC opinion

  Favourable Opinion