Feeding Late and Moderately Preterm Infants (FLAMINGO)
Research type
Research Study
Full title
Feeding Late and Moderately Preterm Infants Nutrition and Growth Outcomes (FLAMINGO)
IRAS ID
237542
Contact name
Janet Berrington
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN15469594
Clinicaltrials.gov Identifier
18/NE/0040, REC NE-York ; 37485, CPMS / Portfolio ID
Duration of Study in the UK
4 years, 3 months, 30 days
Research summary
The rates of premature birth are increasing, with most occurring between 32 and 36 weeks gestation, so-called Late and Moderately PreTerm (LMPT) infants. These babies weigh 1.25-2.5kg at birth and have different nutritional requirements to those born full term. However, most nutrition studies have tended to focus on extremely premature infants (gestation <32 weeks) and there are few data on growth in LMPT infants.
There are strong data to show that breast-feeding results in better outcomes, but establishing breast-feeding in LMPT infants is challenging as many initially require support with nasogastric tubes. The duration of breast-feeding in the UK is shorter than other countries, and most LMPT infants grow more slowly. In later life LMPT infants are more likely to require additional educational support, and more likely to be obese as adults. These later life complications are associated with nutrition in early life, but there are few longitudinal studies.
The FLAMINGO study (Feeding Late And Moderately preterm Infants Nutrition and Growth Outcomes) will collect nutrition data in LMPT infants until 2 years age, including breast-feeding, use of vitamin supplements, growth (weight, length etc.), body composition (fat mass etc.) and age at introduction of solid foods. The study will provide parents with expert advice on optimal feeding practices based on up to date international consensus guidelines and will strongly support breast feeding. If parents choose not to continue breast-feeding, infants will be eligible to join a randomised trial. In this, a standard milk formula will be compared to an intervention formula that only differs in the structure of the fat globule (the amount of fat is the same). The larger fat globule in the intervention formula is more similar to human milk. Differences in weight gain and fat mass will be determined. There are no significant risks associated with this dietary study.
REC name
North East - York Research Ethics Committee
REC reference
18/NE/0040
Date of REC Opinion
11 Apr 2018
REC opinion
Further Information Favourable Opinion