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Growth and Tolerance of Young Infants Fed Infant Formulas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01380886
First received: June 16, 2011
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Infant Newborn
Other: experimental infant formula with alternate protein source
Other: Infant formula powder
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 Young Infants Fed Infant Formulas

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Weight gain [ Time Frame: 119 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gastrointestinal tolerance [ Time Frame: 119 days ] [ Designated as safety issue: No ]
    Stool characteristics, number of stools per day, and number of feedings associated with spit up or vomit

  • Anthropometric variables [ Time Frame: 119 days ] [ Designated as safety issue: No ]
    Length gain per day and head circumference gain per day


Enrollment: 209
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 8 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT01380886

Locations
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
Investigators
Study Chair: Marlene Borschel, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01380886     History of Changes
Other Study ID Numbers: AK92
Study First Received: June 16, 2011
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014