Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate
Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate
The aim of this study is to assess weight gain of preterm infants (gestational age lower than
 32 weeks) fed infant milk formula with about 60% beta-palmitate (EX_IMF) vs infant milk
 formula with similar macronutrient, mineral and fatty acid composition but lower amounts of
 beta-palmitate (ST_IMF). Own mother milk (OMM) fed infants will serve as reference group.
A large number of low birth weight infants during their hospital stay experience poor growth
 and this has been linked to reduced neurodevelopment scores.

 Several enriched infant milk formulas are available for preterm infants who cannot be fed
 human milk. The use of infant milk formulas (IMF) enriched with triglycerides similar to
 human milk lipids have shown to be associated with better fatty acid and mineral intestinal
 absorption.

 In this multicenter, randomized, controlled clinical trial, preterm infants (gestational age
 lower than 32 weeks), who can not be fed human milk, will be randomized to receive IMF with
 high or low amounts of beta-palmitate (about 60% vs 10%, respectively). A non-randomized own
 human milk-fed group will be included as a reference. Patients will be on the study diet as
 soon as possible after birth and till 36 weeks of gestation. Neurodevelopment follow-up will
 be performed at 24 months corrected age.
Inclusion Criteria:

 -  gestational age between 24 and 32 weeks of gestation at enrollment,

 -  birth weight greater than 750 grams,

 -  singleton or twin birth (no triplet or higher),

 -  fraction of inspired oxygen lower than 0.60 at enrollment,

 -  feasible enteral feeding,

 -  cardiovascular stable condition,

 -  informed consent form signed by at least one parent or legal guardian.

 Exclusion Criteria:

 -  congenital malformations, genetic, metabolic and endocrine disorders,

 -  suspicious infection at enrollment,

 -  intrauterine growth restriction (<10th centile) at enrollment,

 -  maternal diabetes requiring insulin therapy,

 -  neonatal asphyxia.