Growth and Tolerance of Hypoallergenic Formulas

Completed

• Conditions: Growth of Term Infants

• Registration Number: NCT01354366
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Study Start: 2011-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-28
• Last Update Posted: 2013-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

Inclusion Criteria

• Singleton, 12-16 days of age at randomization
• Term infant with birth weight of a minimum of 2500 grams
• Solely formula fed
• Signed Informed Consent and Protected Health Information

Exclusion Criteria

• History of underlying metabolic or chronic disease or immunocompromised
• Feeding difficulties or formula intolerance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight measured at each study visit	3.5 months

Secondary Outcome Measures

Name	Time	Method
Recall of infant formula intake at each study visit	3.5 months
Body Length and Head Circumference measured at each study visit	3.5 months
Recall of stool characteristics and tolerance at each study visit	3.5 months
Medically-confirmed adverse events collected throughout the study period	3.5 months
Parental Product Assessment Questionnaire completed at Study Visit 2	once

Trial Locations

Locations (24)

Birmingham Pediatric Associates; 🇺🇸 Birmingham, Alabama, United States

Southeastern Pediatric Associates; 🇺🇸 Dothan, Alabama, United States

Pediatrics East - Alabama Clinical Therapeutics; 🇺🇸 Pinson, Alabama, United States

Central Arkansas Pediatric Clinic; 🇺🇸 Benton, Arkansas, United States

The Children's Clinic of Jonesboro; 🇺🇸 Jonesboro, Arkansas, United States

Arkansas Pediatric Clinic; 🇺🇸 Little Rock, Arkansas, United States

Norwich Pediatric Group, P.C.; 🇺🇸 Norwich, Connecticut, United States

Altamonte Pediatric Associates; 🇺🇸 Lake Mary, Florida, United States

Children's Medical Association; 🇺🇸 Plantation, Florida, United States

North Georgia Clinical Research Center/White's Pediatrics; 🇺🇸 Dalton, Georgia, United States

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