Status:
COMPLETED
Growth and Tolerance of Infants Fed Infant Formulas
Lead Sponsor:
Abbott Nutrition
Conditions:
Growth and Tolerance
Eligibility:
All Genders
Up to 5 years
Phase:
NA
Brief Summary
To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.
Eligibility Criteria
Inclusion
- Singleton from full term birth with a gestational age 37-42 weeks
- Birth weight \> 2490 g (\~5 lbs 8 oz)
- Between 0 and 5 days of age
- Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
- Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
- Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study
- No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
Exclusion
- Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development
- Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
- Treatment with antibiotics
- Mother intends to use a combination of breast and formula feeding
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT01808105
Start Date
April 1 2013
End Date
February 1 2014
Last Update
June 2 2014
Active Locations (25)
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1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35205
2
Alabama Clinical Therapeutics
Dothan, Alabama, United States, 36305
3
W.O.M.B Watching Over Mothers and Babies
Tucson, Arizona, United States, 85712
4
Clinical Research Advantage/Colorado Springs Health Partners
Colorado Springs, Colorado, United States, 80920