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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014