NCT04541095

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jan 2023Dec 2027

First Submitted

Initial submission to the registry

September 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 16, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

2.9 years

First QC Date

September 1, 2020

Last Update Submit

January 20, 2023

Conditions

Weight Gain

Keywords

GrowthPreterm InfantsBeta-palmitateInfant formulaHuman milk

Outcome Measures

Primary Outcomes (1)

  • Weight gain

    Body weight will be daily measured by using an electronic balance (g/kg).

    From birth to 36 weeks of gestational age or until discharge if this occurred before.

Secondary Outcomes (42)

  • Crying

    For 1 consecutive day at 32, 34 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..

  • 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.

  • Stool biochemical composition - Palmitic acid

    At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.

  • +37 more secondary outcomes

Study Arms (3)

EX_IMF group

EXPERIMENTAL

Infants will receive infants formula with large amounts of beta-palmitate (EX\_IMF).

Other: EX_IMF

ST_IMF group

ACTIVE COMPARATOR

Infants will receive infants formula with low amounts of beta-palmitate (ST\_IMF).

Other: ST_IMF

HM group

NO INTERVENTION

Infants will receive human milk (HM).

Interventions

EX_IMFOTHER

Infant formula with large amounts of beta-palmitate (about 60%).

EX_IMF group
ST_IMFOTHER

Infant formula with low amounts beta-palmitate (about 10%).

ST_IMF group

Eligibility Criteria

Age24 Weeks - 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ospedali Riuniti di Ancona

Ancona, 60123, Italy

RECRUITING

Istituto di Ricerca Città della Speranza

Padua, 35127, Italy

NOT YET RECRUITING

Related Publications (7)

  • 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: 10429008BACKGROUND

  • 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: 2057024BACKGROUND

  • 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: 7990660BACKGROUND

  • 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: 16540799BACKGROUND

  • 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: 8985844BACKGROUND

  • 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: 7733025BACKGROUND

  • 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: 9462186BACKGROUND

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Virgilio Carnielli, MD, PHD

CONTACT

0715962045v.carnielli@staff.univpm.it

Alessio Correani, MSc, PHD

CONTACT

0715962888a.correani@pm.univpm.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Director of Neonatology

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 9, 2020

Study Start

January 16, 2023

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2027

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

IT(2)