We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Growth and Tolerance of Young Infants Fed Infant Formulas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01380886
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.

Condition or disease Intervention/treatment Phase
Infant Newborn Other: experimental infant formula with alternate protein source Other: Infant formula powder Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Growth and Tolerance of Young Infants Fed Infant Formulas
Study Start Date : June 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Infant formula, alternate protein source
Experimental infant formula with alternate protein source
Other: experimental infant formula with alternate protein source
experimental infant formula to be fed ad libitum
Active Comparator: Infant formula powder
Infant formula powder
Other: Infant formula powder
powdered infant formula to be fed ad libitum

Outcome Measures

Primary Outcome Measures :
  1. Weight gain [ Time Frame: 119 days ]

Secondary Outcome Measures :
  1. gastrointestinal tolerance [ Time Frame: 119 days ]
    Stool characteristics, number of stools per day, and number of feedings associated with spit up or vomit

  2. Anthropometric variables [ Time Frame: 119 days ]
    Length gain per day and head circumference gain per day

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   up to 8 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy infant
  • full term
  • birth weight > 2490 g
  • 0 to 8 days of age
  • parent/physician agree to not use medications affecting tolerance/growth
  • parent agrees to sole source feeding of study formula
  • parent agrees to not use vitamin/mineral supplements
  • parent has signed consent/HIPAA authorization

Exclusion Criteria:

  • any maternal, fetal, or infant history affecting growth and tolerance
  • participation in any other study not preapproved by Abbott
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380886

United States, Connecticut
Norwich Pediatric Group, PC
Norwich, Connecticut, United States, 06360
United States, Florida
SCORE Physician Alliance, LLC
St. Petersburg, Florida, United States, 33710
United States, Indiana
Northpoint Pedicatrics, LLC
Indianapolis, Indiana, United States, 46038
United States, Kentucky
Springs Medical Research, LLC
Owensboro, Kentucky, United States, 42303
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89104
United States, North Carolina
Cary Pediatric Center
Cary, North Carolina, United States, 27518
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Ohio Pediatric Research Association, INC.
Huber Heights, Ohio, United States, 45424
Institute of Clinical Research
Mayfield Heights, Ohio, United States, 44124
The Cleveland Pediatric Research Center
Parma, Ohio, United States, 44129
United States, South Dakota
Sanford Clinic Family Medicine
Sioux Falls, South Dakota, United States, 57105
United States, Texas
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Sponsors and Collaborators
Abbott Nutrition
Study Chair: Marlene Borschel, PhD Abbott Nutrition
More Information

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01380886     History of Changes
Other Study ID Numbers: AK92
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013