Preterm Milk Fortification in Neonates: PUFFIN
Research type
Research Study
Full title
Breastmilk fortification in preterm infants: a randomised controlled trial of two nutritionally equivalent fortifiers (PUFFIN - preterm milk fortification in neonates)
IRAS ID
293189
Contact name
Janet Berrington
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
This is a three site non-blinded randomised trial exploring two nutritionally equivalent fortifiers as supplements to breast milk for babies born before 32 weeks gestation or <1500g birthweight. Mothers will be fully supported to provide their own breast milk, and any shortfall will be made up with standard human donor milk. Preterm and small babies often struggle to grow on breast milk (maternal or donor) alone, and commercially available cows milk based fortifiers are currently added to breast milk to help growth. A human based powdered fortifier is now commercially available. This study will compare gut inflammation through measures done on the stool (and blood/urine where available) and other neonatal outcomes to discharge from the neonatal unit, between infants fortified with the standard cows milk based product and the human based product. No other changes to infant or mother care will take place. The intervention starts when infants are fully fed on breast milk (i.e they have no intravenous feeds and are tolerating 150mls/kg/day of milk) and ends at 36 weeks gestation, or when fortifier is no longer required, whichever is earlier.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0224
Date of REC Opinion
21 Oct 2021
REC opinion
Further Information Favourable Opinion