A 16-Week Growth Study of an Extensively Hydrolyzed Infant Formula, 3 Months Treatment and 1 Month Follow-up for a Duration of 4 Months.

Perrigo Nutritionals1 site in 1 country35 target enrollmentJuly 2007

ConditionsGrowth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth
Sponsor: Perrigo Nutritionals
Enrollment: 35
Locations: 1
Primary Endpoint: An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants
Status: Completed
Last Updated: 16 years ago

The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

December 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•At birth:
•Healthy, term (37-42 weeks) infant
•Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
•At time of enrollment:
•\< or = 21 days post-natal age
•Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
•Exclusively formula fed
•Written informed consent of parent/guardian

•At the time of enrollment: partially human-milk fed; fed baby/solid foods
•Conditions requiring feedings other than those specified in the protocol
•Documented or suspected cow's milk allergy and/or soy protein allergies
•Major congenital deformities
•Suspected or documented systemic or congenital infections
•Evidence of cardiac, respiratory, hematological, gastrointestinal, or other systemic diseases
•Participation in any other clinical trial