Feeding preterm infants different formulas with varying beta-palmitate levels
Official title: A Randomized, Multicenter, Controlled Clinical Trial to Assess Weight Gain of Preterm Infants Fed a New Infant Milk Formula Containing High Amounts of Beta-palmitate Versus a Standard Infant Milk Formula Containing Low Amounts of Beta-palmitate
Run by Ospedali Riuniti Ancona · NCT04541095 · Data updated 2026-11-12
This study tests if feeding preterm infants different formulas with high or low levels of a fat called beta-palmitate helps them gain weight better than those who are fed their mother's milk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 24 Weeks to 32 Weeks |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Ospedali Riuniti Ancona Academic / other |
| Locations | 2 sites (Ancona and 1 other locations) |
| Status | Recruiting |
| Started | January 16, 2023 |
| Main results expected | December 2025 |
| Study ends | December 2027 |
| Registry record updated | January 25, 2023 |
| Trial ID | NCT04541095 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are preterm infants with a gestational age between 24 and 32 weeks and a birth weight greater than 750 grams.
✕Probably not a fit
Patients with congenital malformations, genetic disorders, or those requiring insulin therapy for maternal diabetes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the weight gain of preterm infants born before 32 weeks of gestation who are fed infant milk formulas containing either high (60%) or low (10%) amounts of beta-palmitate. The study will compare these two groups against a reference group of infants fed their own mother's milk. The infants will be randomized to receive one of the two formulas as soon as possible after birth and will continue until they reach 36 weeks of gestation. Additionally, neurodevelopmental follow-up will be conducted at 24 months corrected age to assess long-term outcomes.
Why it matters
Potential benefit: If successful, this study could improve weight gain and neurodevelopmental outcomes in preterm infants who cannot be fed human milk.
How similar studies have gone: Previous studies have shown that enriched infant milk formulas can improve growth outcomes in preterm infants, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Ospedali Riuniti di Ancona
Ancona, Italy Recruiting -
Istituto di Ricerca Città della Speranza
Padua, Italy Not yet recruiting
Study contacts
- Study coordinator: Virgilio Carnielli, MD, PHD
- Email: v.carnielli@staff.univpm.it
- Phone: 0715962045
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.