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

Launched by OSPEDALI RIUNITI ANCONA · Sep 1, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at how different types of infant milk formulas affect weight gain in preterm infants, specifically those born before 32 weeks of pregnancy. Researchers want to compare a formula that contains a higher amount of a special fat called beta-palmitate to one that has less of this fat but is otherwise similar. Also, babies who are fed their own mother's milk will be used as a comparison group. The goal is to see which formula helps preterm infants grow better.

To participate in this study, babies need to be born between 24 and 32 weeks of pregnancy and weigh more than 750 grams. They should also be stable enough to begin feeding and have a parent or guardian who can give consent to join the trial. If a baby has certain health issues or infections, they won't be eligible. For families considering this trial, it's important to know that they will be helping researchers learn more about how to support the growth of preterm infants, which could benefit many babies in the future.

Gender

ALL

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.