Neurodevelopment Clinical Trial
Official title:
Individualized Fortification of Breast Milk With Fat, Carbohydrate and Protein for Preterm Infants
The proposed research will investigate individualized fortification of breast milk based on
daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind
controlled trial. The combination of additional fat, carbohydrate and protein and commercial
fortifier will be added to ensure that the milk contains the target amounts of nutrient.
Growth and development of these infants will be compared with that of infants fed mother's
milk that has been supplemented with the current standard amounts. The postnatal growth of
the infants will be assessed by measuring weight, length and head circumference and fat and
lean mass using highly accurate, non-invasive methods throughout the intervention period and
at the first follow-up visit after discharge at 3 months. Neurological development will be
analyzed at the age of 18 months.
The investigators hypothesize that individualized fortification of breast milk improves the
nutritional intake of preterm infants, optimizing growth, and thus this will positively
impact neurodevelopment and health.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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