Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula

Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula

To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.

Inclusion Criteria:

• Premature infant 28 to 33 weeks gestational age, inclusive, at birth
• Infant has never received enteral feedings or current enteral intake is less than 30 mL/kg/day
• Birth weight is greater than or equal to 700g to 1750g
• Appropriate birth weight for gestational age
• Singleton or twin birth
• Signed Informed consent

Exclusion Criteria:

• Infant's mother plans to exclusively breast feed
• 5 minute APGAR score is less than or equal to 4
• Major surgery that required general anesthesia prior to randomization
• Ventilator-dependent or requiring greater than 40% FiO2 on day of randomization
• Grade III or IV intraventricular hemorrhage diagnosed prior to randomization
• Infant is currently participating in another clinical study