Feeding Late and Moderately Preterm Infants Nutrition and Growth Outcomes (FLAMINGO)
Late and moderately preterm infants
Please note that infants are first recruited to an observational cohort. From within this cohort infants who are eligible will be enrolled to an RCT. Outcomes are the same for both groups. Infants will be enrolled and randomised using an online randomisation programme https://www.sealedenvelope.com. Infants are assigned to a product code (A, B, C or D) using a minimisation process (with a 30% chance of simple random allocation) and will use two stratification factors. All members of the research team are blinded to treatment allocation. Stratification is applied for: 1. Multiple births (single vs multiple birth) 2. Gestational age (32-33 vs 34-36 weeks) In case of multiple births, the first eligible sibling is randomised according to the stratification factors above and if applicable, the other sibling(s) will be automatically provided the same treatment code. Infants will be allocated of two study formula milks (control and intervention) which will be fed on demand until 6 months corrected age (total duration 6 – 7 months). Infants will be reviewed by telephone and at pre-planned clinic visits. After 6 months corrected age the study intervention will stop and infants will be advised on feeding methods according to standard guidelines. Infants will be followed in clinic until 2 years corrected age. The two milk formula meet international recommendations for nutrient intakes in infancy and contain similar amounts of macro- and micro-nutrients. They differ only in the structure of the lipid droplet which is larger in the intervention formula.
1. Healthy moderate to late preterm infants (gestational age ≥ 32 and ≤ 36 6/7 weeks) 2. Age at inclusion ≤ term equivalent age 3. Birth weight between 1.25-2.5 kg 4. Infants who are predominantly formula fed (max. 1 breastfeeding per day) using a standard term infant formula 5. Written informed consent from parent(s) and/or legal guardian, aged ≥ 18 years, to be enrolled into a randomised trial
1. Any gastrointestinal, congenital or other problem likely to affect growth and nutrition, or requiring use of specialised milk formula or other diet e.g. due to confirmed allergy; or where the attending medical team feel that trial participation is inappropriate for any other medical condition 2. Ongoing child protection procedures or maternal drug misuse requiring social services involvement 3. Family circumstances where follow-up not likely to be possible e.g. family travel abroad for prolonged periods, or where it appears likely that the family will be unable to comply with the necessary research visits 4. Participation in another interventional study that may potentially confound or interact with this study 5. Family unable to understand English