Study Title
“Feeding in Late And Moderately preterm Infants Nutrition and Growth Outcomes (FLAMINGO): a cohort study with an embedded randomised, controlled, double-blind trial in formula-fed infants to investigate the effects of a new infant formula on growth and body composition.”
The study is registered at ISRCTN, with the number ISRCTN15469594. More details can be found here
Study Objectives
The overall objective of the FLAMINGO cohort is to study growth and body composition outcomes in Late And Moderately preterm (LMPT) infants until 24 months corrected age and to determine any associations of exposure to breast-milk and age at introduction of solid foods.
The primary objective of the FLAMINGO study, a randomised controlled trial (RCT) embedded in the cohort, is to demonstrate that growth until 3 months corrected age in LMPT infants fed an innovative infant formula with a lipid structure closer to human milk is non-inferior to those fed a standard term formula.
Description
The rates of premature birth are increasing, with most occurring between 32 and 36 weeks gestation – called Late and Moderately PreTerm (LMPT) infants. These infants usually weigh 1.25-2.5kg at birth and may have different nutritional requirements to those born full term. In later life LMPT infants are more likely to require additional educational support and develop metabolic complications or become overweight and obese as adults. These later life complications are associated with nutrition in early life.
Studies describing the longitudinal postnatal growth and development of LMPT infants are also scarce. The FLAMINGO study aims to gain more insights in the role of early life nutrition in infant growth and development of LMPT infants.
Methodology and intervention
In the FLAMINGO study infants are first recruited to an observational cohort, with infants from this cohort who fulfil the inclusion criteria having the opportunity to be enrolled to an RCT. The outcomes assessed are largely the same for both parts of the study.
The FLAMINGO cohort study will collect nutrition data in LMPT infants until 2 years age, including breastfeeding, use of vitamin supplements, growth, body composition 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 breastfeeding.
If parents choose not to continue breastfeeding, infants will be eligible to join an RCT. Infants included in the RCT will be allocated to one of two study formula milks (control or concept formula) until 6 months corrected age. Infants will be provided with study product until 6 months corrected age and parents will be advised on feeding methods according to standard guidelines and followed in a clinic setting until 2 years corrected age. Both milk formulae meet international recommendations for nutrient intakes in infancy and contain similar amounts of macro- and micro-nutrients. They differ in the structure of the lipid droplet with the intervention milk formula containing the patented Nuturis® process with large, phospholipid coated lipid droplets that mimic the structure of lipids in human milk. The amount of fat is the same in both formulae.
Find out more about Nuturis®’ lipid droplets here. here.
The aim is to recruit 140 subjects in the RCT, with an anticipated 250 subjects in the cohort study. Each subject will be included from randomisation until study end for a maximum of 25 months, comprising of a 6-7 month intervention period in the RCT and a follow up period until a corrected age of 24 months of age. Recruitment is expected to be completed in April 2022.
Outcome Measures
The primary outcome of the study is daily weight gain from randomisation until 3 months corrected age. Weight will be measured at baseline, discharge, term equivalent age, 3, 6, 12 and 24 months corrected age.
Secondary outcome parameters include growth and body composition, neurodevelopment and nutrition and eating behaviour parameters, with the addition of safety and tolerance parameters in the RCT population.
In May 2018 the first infant was enrolled in the cohort study and in July 2018 the first subject entered the randomised controlled trial.
Chief Investigator & participating centre
Dr Nicholas D Embleton, Consultant Neonatal Paediatrician
Royal Victoria Infirmary, Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP, United Kingdom
For more information please contact: Annemarie Zimmerman-Oosting, Danone Research & Innovation (annemarie.oosting@danone.com).
For more information on Danone Research & Innovation’s work in preterm infants please see here
