COLLABORATE

THE STUDY

COLLABORATE is 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 extremely preterm babies.

STUDY GOALS

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

FUNDER AND SPONSOR

COLLABORATE is funded by the National Institute for Health Research and sponsored by Imperial College London. COLLABORATE is a National Neonatal Research Database enabled study and will be delivered by the Imperial Clinical Trials Unit

TRIAL REGISTRATION: ISRCTN10443084

ENGAGEMENT MATERIALS

• EXPLAINER VIDEOS (watch this short explainer below):

• STUDY RATIONALE AND DESIGN (FOR CLINICIANS/INVESTIGATORS)

To download the presentation on study rationale and design, please click the link below:

PowerPoint Presentation of the COLLABORATE Study Rationale and Design

• FLIERS

To print the COLLABORATE Fliers 1 to 4, please click the link below:

COLLABORATE Fliers for Print

• STUDY DOCUMENTS: PROTOCOL AND PARENT INFORMATION SHEETS (PIS)

Please download the PDF version of the study documents below:

COLLABORATE Protocol (Version: 3.0, 09/01/2026)

COLLABORATE PIS Part 1 (Version: 2.1, 12/12/2025)

COLLABORATE PIS Part 2 (Version: 2.0, 22/10/2025)

^{Translated versions of the PIS are available in Arabic, Bengali, Gujarati, Italian, Polish, Portuguese, Punjabi, Romanian, Spanish, and Urdu. Please contact the COLLABORATE team to request a copy.}

INVESTIGATORS

COLLABORATE is led by Victoria CORNELIUS (Professor of Medical Statistics and Trial Methodology, Imperial College London), Neena MODI (Professor of Neonatal Medicine, Imperial College London), James BOARDMAN (Professor of Neonatal Medicine, University of Edinburgh), Peter BRADLEY (Director of Services, Bliss), Lauren INGLEDOW (Adult Preemie Advocacy Network), Annemarie LODDER (Parent, Patient and Public Involvement and Engagement Lead, Pregnancy and Prematurity theme, NIHR Biomedical Research Centre, Imperial College London), Ramon LUENGO-FERNANDEZ (Associate Professor of Health Economics, University of Oxford), Andrew MORRIS (Director, Health Data Research UK), John NORRIE (Professor of Medical Statistics, Queen’s University Belfast), Shalini OJHA (Professor of Neonatal Medicine, University of Nottingham), David QUINE (Consultant Neonatologist, Edinburgh Royal Infirmary), Sabita UTHAYA (Consultant Neonatologist, Professor of Practice, Imperial College London), James WASON (Professor of Biostatistics, University of Newcastle), and Hilary WONG (Consultant Neonatologist, Affiliated Assistant Professor, University of Cambridge)

FOLLOW COLLABORATE

Our official social media accounts

YouTube, LinkedIn, Bluesky

CONTACTS

Please email us at COLLABORATE@imperial.ac.uk if you have any questions or would like us to visit your neonatal unit or network to discuss COLLABORATE.