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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 7 months
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
Ospedali Riuniti di Ancona
RECRUITING
Ancona
Istituto di Ricerca Città della Speranza
NOT_YET_RECRUITING
Padua
Contact Information
Primary
Virgilio Carnielli, MD, PHD
v.carnielli@staff.univpm.it
0715962045
Backup
Alessio Correani, MSc, PHD
a.correani@pm.univpm.it
0715962888
Time Frame
Start Date: 2023-01-16
Estimated Completion Date: 2027-12
Participants
Target number of participants: 150
Treatments
Experimental: EX_IMF group
Infants will receive infants formula with large amounts of beta-palmitate (EX\_IMF).
Active_comparator: ST_IMF group
Infants will receive infants formula with low amounts of beta-palmitate (ST\_IMF).
No_intervention: HM group
Infants will receive human milk (HM).
Related Therapeutic Areas
Sponsors
Leads: Ospedali Riuniti Ancona
Collaborators: Bunge Loders Croklaan, Istituto di Ricerca Pediatrica Città della Speranza