Background and study aims
The rates of premature birth are increasing, with most occurring between 32 and 36 weeks gestation, 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 breastfeeding results in better outcomes, but establishing breastfeeding in LMPT infants is challenging as many initially require support with nasogastric tubes. The duration of breastfeeding 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.
Who can participate?
Healthy LMPT infants
What does the study involve?
Nutrition data is collected until 2 years of age, including breastfeeding, use of vitamin supplements, growth (weight, length etc), body composition (fat mass etc) and age at introduction of solid foods. If parents choose not to continue breastfeeding, infants are randomly allocated to either a standard milk formula or 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 are measured.
What are the possible benefits and risks of participating?
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. The specific study design is chosen to be fully supportive of breastfeeding as preferred nutrition in early life, and will adhere to all aspects of the WHO code on the use of breastmilk substitutes as well as supporting the Baby Friendly Initiative (BFI, UNCIEF). It offers all participants regardless of maternal feeding choice the opportunity for close follow-up and advice from a paediatrician. There are no significant risks for those taking part as all formula used meet current international recommendations. However, there may be minimal disruption to family life as parents will need to return to the hospital for regular clinic visits until 2 years of age.
Where is the study run from?
Royal Victoria Infirmary (UK)
When is the study starting and how long is it expected to run for?
April 2018 to May 2023
Who is funding the study?
Danone Nutricia Research (Netherlands)
Who is the main contact?
Dr Nicholas Embleton
nicholas.embleton@ncl.ac.uk