Feeding preterm infants different formulas with varying beta-palmitate levels
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 24 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | Ospedali Riuniti Ancona Academic / other |
| Locations | 2 sites (Ancona and 1 other locations) |
| Trial ID | NCT04541095 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with congenital malformations, genetic disorders, or those requiring insulin therapy for maternal diabetes may not benefit from this study.
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 performed: Previous studies have shown that enriched infant milk formulas can improve growth outcomes in preterm infants, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Ancona and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.