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

Recruiting now · Not applicable

Conditions studied: Weight Gain

In brief

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.

Key facts

Study ID

NCT04541095

Run by

Ospedali Riuniti Ancona

People needed

150

Starts

2023-01-16

Expected to finish

2027-12-01

Last updated by the study team

2023-01-25

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Ospedali Riuniti di Ancona — Ancona, Italy (enrolling)
• Istituto di Ricerca Città della Speranza — Padua, Italy

Full record on ClinicalTrials.gov

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