RecruitingInterventional

A UK-wide study to find out which routine top-up feeds for extremely preterm babies when there is insufficient own mother’s milk, reduce the likelihood of necrotising enterocolitis and improve survival and brain development

This UK-wide study aims to improve the care of babies born very early, before 29 weeks. Researchers want to find the best routine 'top-up' feeds when a mother's own milk isn't enough. They will compare using donor breast milk versus special formula. They also want to see if routinely adding extra nutrients to milk (fortification) is better than not routinely doing so. The goal is to reduce serious gut problems (called necrotising enterocolitis), improve survival, and help with brain development. All feeding methods used in this study are already part of standard care in hospitals. It's hoped the findings will help many very premature babies in the future.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

3,252

Start

19 Jan 2026

Estimated completion

30 Nov 2027

Necrotising enterocolitis, mortality, and cognitive impairment in preterm babies born below 29 weeks gestation

What is this study about?

When babies are born very early, especially before 29 weeks of pregnancy, they need a lot of special care. One of the important things is how they are fed, especially when their mum's own milk isn't always available in large enough amounts. Doctors often have to decide between giving donor breast milk (from another mum) or a special formula made for premature babies. They also need to know if adding extra nutrients, called 'fortification', to a baby's milk routinely is better for their health.

This study, called COLLABORATE, wants to answer these questions. It's looking at which feeding methods help these tiny babies survive better and have fewer serious health problems. One serious problem it aims to prevent is necrotising enterocolitis, a severe inflammation of the gut that can be very dangerous for premature babies. The study will also check for longer-term effects on how babies' brains develop.

All the different feeding options being looked at in this study are already used safely in hospitals across the UK. దిs study isn't trying out new, untested treatments, but rather finding the best way to use the options we already have. By taking part, families will be helping to improve the care for all very premature babies in the future.

Key takeaways

The study helps babies born before 29 weeks.
It compares donor milk vs. special formula.
It also checks if routine milk fortification helps.
Aims to reduce serious gut problems and improve brain development.
All feeding methods are already used in hospitals.
Results will improve future care for premature babies.

Who may be eligible?

This study is for very premature babies born before 29 weeks of pregnancy. To take part, a baby's mum needs to intend to express her own milk, and the baby shouldn't have any serious conditions that would stop them from being fed through their tummy.

Babies can't join the first part of the study if they've already been given donor breast milk or preterm formula. Similarly, for the second part, babies can't join if they've already received fortified milk.

There's also a special, smaller part of the study which involves extra tests. Babies can join this part if they are being cared for at the Royal Infirmary of Edinburgh and don't have certain birth defects or any reasons why they shouldn't have an MRI scan.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Was your baby born before 29 weeks of pregnancy?
Does your baby not have any conditions preventing them from being fed normally?
Do you intend to provide your own breast milk for your baby?
Has your baby not started receiving donor milk, formula, or fortified milk yet (for some parts of the study)?

Answer every question to see your result.

What does participation involve?

If your baby is eligible and you agree for them to take part, the study will involve two main decisions about their feeding. The first decision will be made when your baby needs extra milk because your own milk isn't enough – they will either receive donor breast milk or special formula. The second decision will be about whether your baby's milk is routinely topped up with extra nutrients (fortified) or not. These decisions will be made fairly, like drawing names from a hat.

Apart from these feeding choices, there are no extra appointments or procedures you would need to attend. However, if your baby is part of a small sub-study, they might have a special brain scan (MRI) around their original due date and some samples of their poo collected. Once your baby leaves the hospital, there are no study-related follow-up visits. We would simply ask for permission to look at results from routine checks of your child's thinking and language skills at two years old.

Potential risks and benefits

Taking part in this study means your baby will receive either donor milk, special formula, or fortified milk. All of these feeding options are already commonly used and considered safe in UK hospitals. While your baby might not directly benefit, the information from this study will help doctors provide the best care for other premature babies in the future. Interestingly, studies have shown that babies who take part in research often have slightly better outcomes than similar babies who don't join, which is known as an 'inclusion benefit'. You are free to withdraw your baby from the study at any time without affecting their medical care.

Locations (12)

Chelsea and Westminster Hospital NHS Foundation Trust
City only
London, England
NHS Lothian
Approximate
Edinburgh, Scotland
Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England
University Hospitals of Derby and Burton NHS Foundation Trust
City only
Derby, England
The Shrewsbury and Telford Hospital NHS Trust
City only
Shrewsbury, England
Belfast Health and Social Care Trust
City only
Belfast, England
Northern Health and Social Care Trust
Approximate
Antrim, Northern Ireland
South Eastern Health and Social Care Trust
City only
Belfast, Northern Ireland
Western Health and Social Care Trust
City only
Londonderry, Northern Ireland
Southern Health and Social Care Trust
City only
Craigavon, Northern Ireland
University Hospitals of Leicester NHS Trust
Unverified
Leicester, England
East Kent Hospitals University NHS Foundation Trust
Unverified
Canterbury, England

Common questions

What is 'extremely preterm'?

It means a baby is born very early, before 29 weeks of pregnancy.

What is necrotising enterocolitis?

It's a serious and potentially dangerous swelling and damage to a baby's gut, which disproportionately affects premature babies.

What is donor human milk?

It's breast milk that has been kindly donated by another mother and carefully checked and pasteurised for safety.

What does 'fortification' mean?

It means adding extra nutrients like protein, vitamins, and minerals to milk to help premature babies grow better.

How will the feeding choices be made?

The choices for the different feeding methods will be made randomly, like flipping a coin, to ensure fairness.

How to find out more

Neena Modi

n.modi@imperial.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.