COLLABORATE

Trial Summary

COLLABORATE is an efficient, UK-wide, real-world-data-enabled, digital technology-facilitated, adaptive, group-sequential, 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 extremely preterm babies.

COLLABORATE is supported by NEC UK, Bliss, Adult Preemie Advocacy Network, The George Institute for Global Health, Neonatal Dieticians Interest Group, British Association for Neonatal Neurodevelopmental Follow-Up, and British Association of Paediatric Surgeons.

Randomisation 1 will determine if pasteurised human donor milk or preterm formula affect NEC and other outcomes if a supplement for own mother’s milk is required.

Randomisation 2 will determine if routine macronutrient fortification of human milk is beneficial.

COLLABORATE is led by Professor Victoria Cornelius, Professor Neena Modi, Professor James Boardman, Mr Peter Bradley, Ms Lauren Ingledow, Dr Annemarie Lodder, Professor Ramon Luengo-Fernandez, Professor Andrew Morris, Professor John Norrie, Professor Shalini Ojha, Dr David Quine, Dr Sabita Uthaya, Professor James Wason, and Dr Hilary Wong. It is a National Neonatal Research Database enabled study and will be delivered by the Imperial Clinical Trials Unit

Watch this space; more details to come.