Growth and Tolerance of Young Infants Fed Infant Formulas
1 other identifier
interventional
209
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2011
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 15, 2013
February 1, 2013
6 months
June 16, 2011
February 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Weight gain
119 days
Secondary Outcomes (2)
gastrointestinal tolerance
119 days
Anthropometric variables
119 days
Study Arms (2)
Infant formula, alternate protein source
EXPERIMENTALExperimental infant formula with alternate protein source
Infant formula powder
ACTIVE COMPARATORInfant formula powder
Interventions
experimental infant formula to be fed ad libitum
Eligibility Criteria
You may qualify if:
- healthy infant
- full term
- birth weight \> 2490 g
- 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
You may not qualify if:
- any maternal, fetal, or infant history affecting growth and tolerance
- participation in any other study not preapproved by Abbott
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (12)
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360, United States
SCORE Physician Alliance, LLC
St. Petersburg, Florida, 33710, United States
Northpoint Pedicatrics, LLC
Indianapolis, Indiana, 46038, United States
Springs Medical Research, LLC
Owensboro, Kentucky, 42303, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Cary Pediatric Center
Cary, North Carolina, 27518, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Ohio Pediatric Research Association, INC.
Huber Heights, Ohio, 45424, United States
Institute of Clinical Research
Mayfield Heights, Ohio, 44124, United States
The Cleveland Pediatric Research Center
Parma, Ohio, 44129, United States
Sanford Clinic Family Medicine
Sioux Falls, South Dakota, 57105, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Study Officials
- STUDY CHAIR
Marlene Borschel, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 27, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 15, 2013
Record last verified: 2013-02