Growth and Tolerance of Healthy Term Infants to a New Infant Formula

Phase 3

Terminated

• Conditions: Healthy Term Infants

• Registration Number: NCT01137877
• Lead Sponsor: Abbott Nutrition

Brief Summary

The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-07
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-24
• Last Update Posted: 2010-11-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 399

Inclusion Criteria

• in good health
• singleton full term birth
• Birth weight > 2490 g.
• Infant is between 0 and 11 days of age
• Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance
• If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
• If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition
• not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study

Exclusion Criteria

adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
weight gain	14 to 119 days of age

Secondary Outcome Measures

Name	Time	Method
GI tolerance	14 to 119 days of age
anthropometrics	14 to 119 days of age

Trial Locations

Locations (20)

Arkansas Children's Hospital Research; 🇺🇸 Little Rock, Arkansas, United States

Facey Medical Foundation; 🇺🇸 Mission Hills, California, United States

Norwich Pediatric Group; 🇺🇸 Norwich, Connecticut, United States

All Women's Healthcare of West Broward, Inc; 🇺🇸 Plantation, Florida, United States

SCORE Physician Alliance LLC; 🇺🇸 St. Petersburg, Florida, United States

USF College of Medicine, USF Health, Department of Pediatrics; 🇺🇸 Tampa, Florida, United States

Northpoint Pediatrics; 🇺🇸 Indianapolis, Indiana, United States

University of Louisville Department of Pediatrics; 🇺🇸 Louisville, Kentucky, United States

New England Center for Clinical Research, Inc; 🇺🇸 Fall River, Massachusetts, United States

Wayzata Children's Clinic Ridgeview Research; 🇺🇸 Chaska, Minnesota, United States

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