Preterm Formula, Fortified or Unfortified Human Milk for Very Preterm Infants, the PREMFOOD Study: A Parallel...

Area of Science:

• Neonatal nutrition
• Pediatric gastroenterology
• Clinical trial methodology

Background:

• Optimal supplemental nutrition for very preterm infants with insufficient mother's own milk is uncertain.
• Evaluating different feeding strategies is crucial for infant health outcomes.

Purpose of the Study:

• To assess the feasibility of a randomized controlled trial (RCT) for comparing supplemental diets in very preterm infants.
• To determine the acceptability and safety of different infant feeding regimens.

Main Methods:

• A feasibility trial randomized infants (25-31 weeks gestation) to unfortified human milk (UHM), fortified human milk (FHM), or preterm formula (PTF) supplements.
• Feasibility outcomes included opt-out rates, adherence, and growth safety criteria.
• Body composition and anthropometry were assessed using MRI and standard measurements.

Main Results:

• Opt-out consent for randomization was acceptable (38% opt-out rate).
• Growth parameters and body composition (adipose tissue volume) showed no significant differences between the UHM, FHM, and PTF groups.
• Two infants met slow weight gain criteria, indicating a safe growth profile.

Conclusions:

• Randomization to UHM, FHM, and PTF diets using opt-out consent is feasible and acceptable for parents and clinicians.
• These feeding strategies demonstrated safe growth and comparable body composition in very preterm infants.
• The findings justify proceeding with a larger, powered randomized controlled trial.