Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate

Ospedali Riuniti Ancona

Status: Enrolling

Conditions: Weight Gain

Treatments: Other: ST_IMF; Other: EX_IMF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04541095

PG-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 24 to 32 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

EX_IMF group

Experimental group

Description:

Infants will receive infants formula with large amounts of beta-palmitate (EX_IMF).

Treatment:

Other: EX_IMF

ST_IMF group

Active Comparator group

Description:

Infants will receive infants formula with low amounts of beta-palmitate (ST_IMF).

Treatment:

Other: ST_IMF

HM group

No Intervention group

Description:

Infants will receive human milk (HM).