RecruitingInterventional

Supplementary donor breast milk versus formula as a bridge to exclusive breast milk feeds at discharge in moderate and late preterm infants

This study is investigating the best way to feed babies born a little early, between 33 and 35 weeks. Breast milk is known to be very good for babies, especially those born prematurely, helping their development and reducing time in hospital. When mothers' own milk isn't fully available, very premature babies often receive donor breast milk. This study wants to see if using donor breast milk instead of formula as a top-up for the first few days helps these moderately premature babies feed better, get home sooner, and continue to be breastfed by their mothers. Families at Southmead and Bath Hospitals may be invited to take part.

At a glance

Status

Recruiting

Sponsor

North Bristol NHS Trust

Enrolment target

334

Start

01 Sep 2025

Estimated completion

01 Feb 2028

Encourage breast milk feeds in moderate to late preterm infants (33 to 35 week gestation).

What is this study about?

Breast milk is widely recognised as the best food for all babies, and it's especially important for those born early, often called premature babies. It offers many health benefits, such as helping their brains develop, reducing the chance of infections, and potentially shortening their stay in hospital. For mums, breastfeeding can also be very positive for their well-being. However, premature babies are often less likely to be breastfed compared to babies born at full term.

For babies born very early (before 33 weeks), donor breast milk is often used as a supplement if the mother's own milk isn't fully available. This is because donor milk is usually easier for these tiny babies to digest than formula and can help avoid some health problems. This study focuses on babies born a little later, between 33 and 35 weeks. The researchers want to find out if using donor breast milk as a top-up for these babies, instead of formula, helps them to feed better and go home from hospital sooner. They also want to understand if it helps mothers to continue breastfeeding for longer.

Ultimately, the findings from this study could change how moderately premature babies are fed in hospitals. This could lead to better health outcomes for these babies and provide more support for mothers who want to breastfeed.

Key takeaways

The study aims to improve feeding for babies born between 33 and 35 weeks.
It compares donor breast milk to formula as a top-up for the first 5 days.
Your baby will always receive your own breast milk first if available.
Participation helps future moderate and late preterm babies.
The study runs from January 2024 to August 2028.

Who may be eligible?

This study is looking for families whose babies are born moderately prematurely, specifically between 33 weeks and 35 weeks and 6 days of pregnancy. Your baby can be a single baby or part of a multiple birth (like twins).

To join, mothers must plan to breastfeed their baby, and they must agree for their baby to receive donor breast milk if needed. The baby needs to be enrolled before they are given any supplementary milk feeds. If your baby has certain serious gut problems, or if you don't intend to breastfeed or agree to donor milk, your baby won't be able to take part.

The research team will also make sure your baby is likely to stay in the recruiting hospital for at least 5 days, which is the length of the study intervention. Unfortunately, if a mother is under 16, they cannot give consent for the study.

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.

Is your baby born between 33 and 35 weeks of pregnancy?
Do you plan to breastfeed your baby?
Are you happy for your baby to receive donor breast milk if needed?
Has your baby not yet received any formula milk?
Will your baby likely stay in Southmead or Bath Hospital for at least 5 days?

Answer every question to see your result.

What does participation involve?

If you and your baby take part in this study, your baby will be placed into one of two groups by chance, like flipping a coin. One group will receive donor breast milk as a top-up for the first 5 days if your own milk isn't enough. The other group will receive formula as a top-up during these first 5 days. After these first 5 days, if your baby still needs extra milk, both groups will receive formula.

Throughout the study, if your own breast milk is available, your baby will always be given that first. You and your baby's medical team will work together to decide when and how your baby is fed. The study team will collect information about you and your baby during your hospital stay and for up to 6 months after your baby's original due date, mainly using questionnaires. If your first language is Arabic or Polish, you will be given translated materials and a helper to interpret. Your baby’s GP will be told about their involvement, but all other personal information will be kept private.

Potential risks and benefits

Donor breast milk is provided by screened mothers and is carefully checked and treated (pasteurised) to make it safe. It's already widely used for very premature babies and is considered very safe. While it's safe, some babies might not manage feeds well and could have mild issues like vomiting or bloating; if this happens, your baby's doctors will adjust their feeding plan. We don't yet know if donor breast milk will directly help these moderately premature babies, but by taking part, you'll be helping doctors learn more, which will improve feeding practices for future babies. You are free to withdraw your participation at any time without affecting your baby's care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

North Bristol NHS Trust
City only
Bristol, United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
City only
Bath, United Kingdom

Common questions

What is donor breast milk?

It's breast milk donated by other healthy mothers, carefully screened and treated to be safe for babies.

Will my baby still get my own breast milk?

Yes, if your own breast milk is available, your baby will always receive that first.

What happens after the first 5 days?

If your baby still needs extra milk after 5 days, both study groups will receive formula as a top-up.

How long will the study follow my baby?

Information will be collected during the hospital stay and up to 6 months after your baby's original due date.

Can I leave the study at any time?

Yes, you can pull out of the study at any point, and it won't affect your baby's medical care.

How to find out more

Richard Wach

richard.wach@nbt.nhs.uk +44 117 414 6800 Official trial record

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