Growth and Tolerance of Young Infants Fed Infant Formulas
This study has been completed.
Sponsor:
Abbott Nutrition
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
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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
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 June 18, 2013