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

Phase 3

Terminated

• Conditions: Healthy Term Infants
• Interventions: Other: Milk based infant formula powder; Other: Investigational Infant Formula #1; Other: Investigational Infant Formula #2; Other: Human Milk

• 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

Arm && Interventions

Group	Intervention	Description
Infant Formula #1	Milk based infant formula powder	Milk-based Infant Formula Powder
Investigational Infant Formula #1	Investigational Infant Formula #1	Investigational Milk-based Infant Formula Powder
Investigational Infant Formula #2	Investigational Infant Formula #2	Investigational Milk based infant formula powder
Human Milk	Human Milk	Reference group

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)

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

Midwest Children's Health Research Institute, LLC; 🇺🇸 Lincoln, Nebraska, United States

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

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

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

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

Northpoint Pediatrics; 🇺🇸 Indianapolis, Indiana, United States

Cary Pediatric Center; 🇺🇸 Cary, North Carolina, United States

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

Ohio Pediatric Research Association, Inc; 🇺🇸 Huber Heights, Ohio, United States

Clinical Research Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Dayton Clinical Research; 🇺🇸 Dayton, Ohio, United States

Comprehensive Pediatrics, Inc; 🇺🇸 Westlake, Ohio, United States

Parma Pediatrics; 🇺🇸 Parma, Ohio, United States

Rockwood Clinic North Pediatrics; 🇺🇸 Spokane, Washington, United States

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

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

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

Sanford Clinic Family Medicine 34th and Kiwanis; 🇺🇸 Sioux Falls, South Dakota, United States

DCOL Center for Clinical Research; 🇺🇸 Longview, Texas, United States