Background and study aims

Around 10% of babies are premature (born before 37 weeks), but feeding them is complex. Mothers own breast-milk (MOM) is best and results in better outcomes such as fewer infections, but many mothers do not produce enough milk so either donor human milk (DHM) or a cow's milk derived formula are used to make up the 'shortfall'. Current feeding practices in the UK vary as there is no clear evidence which is best, but both MOM and DHM require fortification with additional nutrients in order to support optimal growth. This currently requires the use of a ‘fortifier’ derived from cow’s milk, but new milk supplements made only from donor human milk are now used in US and Europe. The pattern of gut bacteria in early life is linked to outcomes including infections and allergies, and this is especially important in preterm infants. The aim of this study is to compare two diets in very preterm infants and study the effect on the pattern of gut bacteria and chemicals (metabolites) in stool and urine, as well as growth and body composition.

Who can participate?

Preterm infants born below 29 completed weeks of gestation

What does the study involve?

Babies are randomly allocated to either the standard diet group or the intervention group. To make up any shortfall in MOM, the standard diet group receive a cow's milk formula designed for preterm babies and a fortifier derived from cow's milk, and the intervention group receive DHM and a fortifier derived from human milk. Stool and urine samples are collected to look at patterns of gut bacteria and metabolites, and body composition is measured using an MRI scan.

What are the possible benefits and risks of participating?

There are not enough data to know whether there is any clear advantage to either diet. All babies who participate receive the same level of care regardless of being in the study. There are therefore no clear benefits to babies and parents of taking part, although the information collected may help improve care in the future. This is a dietary study and there are no known risks. Use of any human derived product carries a potential risk of side effects but this has not been reported so far with Prolacta products. The collection of samples for analysis is not associated with any risk.

Where is the study run from?

1. Newcastle Hospitals NHS Foundation Trust (UK)
2. Chelsea and Westminster Hospital (UK)

When is the study starting and how long is it expected to run for?

July 2017 to February 2020

Who is funding the study?

Prolacta Biosciences US

Who is the main contact?

Dr Nicholas Embleton

Trial website

Contact information



Primary contact

Dr Nicholas Embleton


Contact details

Ward 35 Neonatal Unit
Royal Victoria Infirmary
Richardson Road
Newcastle upon Tyne
United Kingdom

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