Growth and Tolerance of Healthy Term Infants to a New Infant Formula
NCT ID: NCT01137877
Last Updated: 2010-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
399 participants
INTERVENTIONAL
2010-05-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Infant Formula #1
Milk-based Infant Formula Powder
Milk based infant formula powder
milk based infant formula ad lib
Investigational Infant Formula #1
Investigational Milk-based Infant Formula Powder
Investigational Infant Formula #1
Milk based infant formula ad lib
Investigational Infant Formula #2
Investigational Milk based infant formula powder
Investigational Infant Formula #2
Milk based infant formula powder ad lib
Human Milk
Reference group
Human Milk
Human milk ad lib
Interventions
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Milk based infant formula powder
milk based infant formula ad lib
Investigational Infant Formula #1
Milk based infant formula ad lib
Investigational Infant Formula #2
Milk based infant formula powder ad lib
Human Milk
Human milk ad lib
Eligibility Criteria
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Inclusion Criteria
* 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
1 Day
11 Days
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Abbott Nutrition
Principal Investigators
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Timberly Williams, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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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
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Cary Pediatric Center
Cary, North Carolina, United States
Dayton Clinical Research
Dayton, Ohio, United States
Ohio Pediatric Research Association, Inc
Huber Heights, Ohio, United States
Parma Pediatrics
Parma, Ohio, United States
Comprehensive Pediatrics, Inc
Westlake, Ohio, United States
Sanford Clinic Family Medicine 34th and Kiwanis
Sioux Falls, South Dakota, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Rockwood Clinic North Pediatrics
Spokane, Washington, United States
Countries
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Other Identifiers
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AK66
Identifier Type: -
Identifier Source: org_study_id