Clinical trial NCT04541095: Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Gain
Keywords: Growth
Preterm Infants
Beta-palmitate
Infant formula
Human milk
Lead sponsor: Ospedali Riuniti Ancona
Sponsor class: OTHER
Collaborators: name: Istituto di Ricerca Pediatrica Città della Speranza
name: Bunge Loders Croklaan
First posted: 2020-09-09
Enrollment: 150
Sex: ALL
Minimum age (years): 24
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight gain
timeFrame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
Secondary outcomes:
measure: Crying
timeFrame: For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Physical activity
timeFrame: For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before..
measure: Stooling pattern
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Stool biochemical composition - Total fatty acids
timeFrame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Stool biochemical composition - Palmitic acid
timeFrame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Stool biochemical composition - Calcium
timeFrame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Stool biochemical composition - Phosphorus
timeFrame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Stool biochemical composition - Magnesium
timeFrame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Stool biochemical composition - Hydroxylic acids
timeFrame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Infant formula intakes
timeFrame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
measure: Human milk intakes
timeFrame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
measure: Parenteral nutrition intakes - cumulative volume
timeFrame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
measure: Parenteral nutrition intakes - amino acids
timeFrame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
measure: Parenteral nutrition intakes - glucose
timeFrame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
measure: Parenteral nutrition intakes - lipids
timeFrame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
measure: Parenteral nutrition duration
timeFrame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
measure: Urinary dicarboxylic acid excretion
timeFrame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Body weight
timeFrame: At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age..
measure: Total body length
timeFrame: At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age.
measure: Head circumference
timeFrame: At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age.
measure: Blood biochemistry - Glycaemia
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Blood biochemistry - Triglycerides
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Blood biochemistry - Cholesterol
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Blood biochemistry - Phospholipids
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Blood biochemistry - Fatty acids
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Blood biochemistry - Urea
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Blood biochemistry - Bilirubin
timeFrame: At 7 and 42 days of postnatal age.
measure: Blood biochemistry - Electrolytes
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Blood biochemistry - Calcium
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Blood biochemistry - Phosphorus
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Total body water
timeFrame: At 36 weeks of gestational age or until discharge if this occurred before.
measure: Stool bifidobacteria
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Gastrointestinal problems
timeFrame: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.
measure: In-hospital death
timeFrame: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.
measure: Complications of prematurity
timeFrame: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.
measure: Neurodevelopmental assessment
timeFrame: At 24 months of corrected age.
measure: Urinary urea
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Urinary calcium
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Urinary phosphorus
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Liver function tests
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Parathyroid hormone
timeFrame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
measure: Metabolic complications
timeFrame: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Ospedali Riuniti di Ancona
city: Padua
country: Italy
facility: Istituto di Ricerca Città della Speranza
Study officials:
References:
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citation: Carnielli VP, Luijendijk IH, van Goudoever JB, Sulkers EJ, Boerlage AA, Degenhart HJ, Sauer PJ. Feeding premature newborn infants palmitic acid in amounts and stereoisomeric position similar to that of human milk: effects on fat and mineral balance. Am J Clin Nutr. 1995 May;61(5):1037-42. doi: 10.1093/ajcn/61.4.1037.
citation: Lucas A, Quinlan P, Abrams S, Ryan S, Meah S, Lucas PJ. Randomised controlled trial of a synthetic triglyceride milk formula for preterm infants. Arch Dis Child Fetal Neonatal Ed. 1997 Nov;77(3):F178-84. doi: 10.1136/fn.77.3.f178.