Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate
NCT ID: NCT04541095
Last Updated: 2023-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2023-01-16
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EX_IMF group
Infants will receive infants formula with large amounts of beta-palmitate (EX\_IMF).
EX_IMF
Infant formula with large amounts of beta-palmitate (about 60%).
ST_IMF group
Infants will receive infants formula with low amounts of beta-palmitate (ST\_IMF).
ST_IMF
Infant formula with low amounts beta-palmitate (about 10%).
HM group
Infants will receive human milk (HM).
No interventions assigned to this group
Interventions
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EX_IMF
Infant formula with large amounts of beta-palmitate (about 60%).
ST_IMF
Infant formula with low amounts beta-palmitate (about 10%).
Eligibility Criteria
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Inclusion Criteria
* 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
* suspicious infection at enrollment,
* intrauterine growth restriction (\<10th centile) at enrollment,
* maternal diabetes requiring insulin therapy,
* neonatal asphyxia.
24 Weeks
32 Weeks
ALL
No
Sponsors
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Istituto di Ricerca Pediatrica Città della Speranza
UNKNOWN
Bunge Loders Croklaan
INDUSTRY
Ospedali Riuniti Ancona
OTHER
Responsible Party
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Virgilio Paolo Carnielli
The Director of Neonatology
Locations
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Ospedali Riuniti di Ancona
Ancona, , Italy
Istituto di Ricerca Città della Speranza
Padua, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PG-1
Identifier Type: -
Identifier Source: org_study_id
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