Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants

Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants

This study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a standard infant formula, while the other half will receive a infant formula with a higher protein level and improved fat blend.

When an infant is born prematurely, the supply of nutrients supporting normal growth and development is interrupted. There is less time to accrue adequate nutrient stores and foetal tissue. The nutritional goal for the preterm infant is to have satisfactory functional development and catch up on growth to match the rate of a full term infant. To achieve this, it is recommended for the infant to have adequate protein intake and suitable fat blend.

Inclusion Criteria:

• Less than or equal to 33 weeks 0 days
• Birth weight less than or equal to 2000g.
• Infant is anticipated to receive the study formula for ≥ 3 consecutive weeks
• At entry into Full Enteral Feeding, study formula will be provided at 50% or more of total enteral feedings.
• Written informed consent has been obtained from the parent/legally authorized representative (LAR).

Exclusion Criteria:

• Peri-/intra-ventricular hemorrhage
• Renal disease
• Hepatic dysfunction
• Major congenital malformations
• Suspected or documented systemic or congenital infections
• Cardiac, respiratory, endocrinologic, hematologic, GI, or other systemic diseases that may impact growth
• Suspected or documented maternal substance abuse
• Infants who have received any experimental treatment or intervention