A Randomized, Multicenter, Controlled Clinical Trial to Assess Weight Gain of Preterm Infants Fed a New Infant Milk Formula Containing High Amounts of Beta-palmitate Versus a Standard Infant Milk Formula Containing Low Amounts of Beta-palmitate

Brief Summary

Detailed Description

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.

Primary Outcomes

Secondary Outcomes

• Stooling pattern(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Stool biochemical composition - Total fatty acids(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Parenteral nutrition intakes - amino acids(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
• Stool biochemical composition - Palmitic acid(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Total body length(At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age.)
• Head circumference(At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age.)
• Blood biochemistry - Triglycerides(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Blood biochemistry - Urea(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Crying(For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Parenteral nutrition intakes - lipids(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
• Stool biochemical composition - Magnesium(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Physical activity(For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before..)
• Stool biochemical composition - Phosphorus(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Stool biochemical composition - Hydroxylic acids(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Human milk intakes(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
• Blood biochemistry - Phospholipids(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Total body water(At 36 weeks of gestational age or until discharge if this occurred before.)
• In-hospital death(Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.)
• Parathyroid hormone(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Parenteral nutrition intakes - cumulative volume(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
• Blood biochemistry - Cholesterol(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Blood biochemistry - Calcium(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Stool bifidobacteria(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Gastrointestinal problems(Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.)
• Stool biochemical composition - Calcium(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Infant formula intakes(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
• Parenteral nutrition intakes - glucose(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
• Parenteral nutrition duration(From birth to 36 weeks of gestational age or until discharge if this occurred before.)
• Body weight(At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age..)
• Blood biochemistry - Fatty acids(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Blood biochemistry - Bilirubin(At 7 and 42 days of postnatal age.)
• Blood biochemistry - Electrolytes(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Neurodevelopmental assessment(At 24 months of corrected age.)
• Liver function tests(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Urinary dicarboxylic acid excretion(At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Blood biochemistry - Glycaemia(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Blood biochemistry - Phosphorus(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Complications of prematurity(Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.)
• Urinary calcium(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Urinary urea(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Urinary phosphorus(At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.)
• Metabolic complications(Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.)