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

Mead Johnson Nutrition

Status: Completed

Conditions: Feeding Intolerance

Treatments: Other: Marketed extensively hydrolyzed casein infant formula; Other: Marketed cow milk-based premature infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01987154

6020

Details and patient eligibility

About

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

Enrollment: 61 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

61 participants in 2 patient groups

Marketed cow milk-based premature infant formula

Active Comparator group

Treatment:

Other: Marketed cow milk-based premature infant formula

Marketed extensively hydrolyzed casein infant formula

Experimental group

Treatment:

Other: Marketed extensively hydrolyzed casein infant formula