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

This study has been terminated.

(The control product was recalled.)

Sponsor:

Information provided by:

Abbott Nutrition

ClinicalTrials.gov Identifier:

NCT01137877

First received: June 3, 2010

Last updated: November 24, 2010

Last verified: November 2010

History of Changes

Purpose

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.

Condition	Intervention	Phase
Healthy Term Infants	Other: Milk based infant formula powder Other: Investigational Infant Formula #1 Other: Investigational Infant Formula #2 Other: Human Milk	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Growth and Tolerance of Healthy Term Infants to a New Infant Formula

Resource links provided by NLM:

MedlinePlus related topics: Infant and Newborn Nutrition

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:

weight gain [ Time Frame: 14 to 119 days of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

GI tolerance [ Time Frame: 14 to 119 days of age ] [ Designated as safety issue: No ]
anthropometrics [ Time Frame: 14 to 119 days of age ] [ Designated as safety issue: No ]

Enrollment:	399
Study Start Date:	May 2010
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Infant Formula #1 Milk-based Infant Formula Powder	Other: Milk based infant formula powder milk based infant formula ad lib
Experimental: Investigational Infant Formula #1 Investigational Milk-based Infant Formula Powder	Other: Investigational Infant Formula #1 Milk based infant formula ad lib
Experimental: Investigational Infant Formula #2 Investigational Milk based infant formula powder	Other: Investigational Infant Formula #2 Milk based infant formula powder ad lib
Active Comparator: Human Milk Reference group	Other: Human Milk Human milk ad lib

Eligibility

Ages Eligible for Study:	up to 11 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137877

Locations

United States, Arkansas
Arkansas Children's Hospital Research
Little Rock, Arkansas, United States, 72202
United States, California
Facey Medical Foundation
Mission Hills, California, United States, 91345
United States, Connecticut
Norwich Pediatric Group
Norwich, Connecticut, United States, 06360
United States, Florida
All Women's Healthcare of West Broward, Inc
Plantation, Florida, United States, 33324
SCORE Physician Alliance LLC
St. Petersburg, Florida, United States, 33710
USF College of Medicine, USF Health, Department of Pediatrics
Tampa, Florida, United States, 33606
United States, Indiana
Northpoint Pediatrics
Indianapolis, Indiana, United States, 46038
United States, Kentucky
University of Louisville Department of Pediatrics
Louisville, Kentucky, United States, 40202
United States, Massachusetts
New England Center for Clinical Research, Inc
Fall River, Massachusetts, United States, 02720
United States, Minnesota
Wayzata Children's Clinic Ridgeview Research
Chaska, Minnesota, United States, 55318
United States, Nebraska
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, United States, 68504
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89123
United States, North Carolina
Cary Pediatric Center
Cary, North Carolina, United States, 27518
United States, Ohio
Dayton Clinical Research
Dayton, Ohio, United States, 45406
Ohio Pediatric Research Association, Inc
Huber Heights, Ohio, United States, 45424
Parma Pediatrics
Parma, Ohio, United States, 44129
Comprehensive Pediatrics, Inc
Westlake, Ohio, United States, 44145
United States, South Dakota
Sanford Clinic Family Medicine 34th and Kiwanis
Sioux Falls, South Dakota, United States, 57105
United States, Texas
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
United States, Washington
Rockwood Clinic North Pediatrics
Spokane, Washington, United States, 99218

Sponsors and Collaborators

Abbott Nutrition

Investigators

Study Chair:

Timberly Williams, PhD

Abbott Nutrition

More Information

No publications provided

Responsible Party:	Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier:	NCT01137877 History of Changes
Other Study ID Numbers:	AK66
Study First Received:	June 3, 2010
Last Updated:	November 24, 2010
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013

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