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

Overview

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.

Interventions

• Other EX_IMF
  Infant formula with large amounts of beta-palmitate (about 60%).
• Other ST_IMF
  Infant formula with low amounts beta-palmitate (about 10%).

Primary outcome measures

• Weight gain [Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.]

Secondary outcome measures (12)

• Crying [Time frame: For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.]
• Physical activity [Time frame: For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before..]
• Stooling pattern [Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.]
• Stool biochemical composition - Total fatty acids [Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.]
• Stool biochemical composition - Palmitic acid [Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.]
• Stool biochemical composition - Calcium [Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.]
• Stool biochemical composition - Phosphorus [Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.]
• Stool biochemical composition - Magnesium [Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.]
• Stool biochemical composition - Hydroxylic acids [Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.]
• Infant formula intakes [Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.]
• Human milk intakes [Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.]
• Parenteral nutrition intakes - cumulative volume [Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 2 centers

• Ospedali Riuniti di Ancona — Ancona
• Istituto di Ricerca Città della Speranza — Padua

Publications

• Ehrenkranz RA, Younes N, Lemons JA, Fanaroff AA, Donovan EF, Wright LL, Katsikiotis V, Tyson JE, Oh W, Shankaran S, Bauer CR, Korones SB, Stoll BJ, Stevenson DK, Papile LA. Longitudinal growth of hospitalized very low birth weight infants. Pediatrics. 1999 Aug;104(2 Pt 1):280-9. doi: 10.1542/peds.104.2.280. PMID 10429008
• Hack M, Breslau N, Weissman B, Aram D, Klein N, Borawski E. Effect of very low birth weight and subnormal head size on cognitive abilities at school age. N Engl J Med. 1991 Jul 25;325(4):231-7. doi: 10.1056/NEJM199107253250403. PMID 2057024
• Innis SM, Dyer R, Nelson CM. Evidence that palmitic acid is absorbed as sn-2 monoacylglycerol from human milk by breast-fed infants. Lipids. 1994 Aug;29(8):541-5. doi: 10.1007/BF02536625. PMID 7990660
• Straarup EM, Lauritzen L, Faerk J, Hoy Deceased CE, Michaelsen KF. The stereospecific triacylglycerol structures and Fatty Acid profiles of human milk and infant formulas. J Pediatr Gastroenterol Nutr. 2006 Mar;42(3):293-9. doi: 10.1097/01.mpg.0000214155.51036.4f. PMID 16540799
• Carnielli VP, Luijendijk IH, Van Goudoever JB, Sulkers EJ, Boerlage AA, Degenhart HJ, Sauer PJ. Structural position and amount of palmitic acid in infant formulas: effects on fat, fatty acid, and mineral balance. J Pediatr Gastroenterol Nutr. 1996 Dec;23(5):553-60. doi: 10.1097/00005176-199612000-00007. PMID 8985844
• 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. PMID 7733025
• 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. PMID 9462186

Identifiers

NCT: NCT04541095 · PG-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗