Status:
TERMINATED
Growth and Tolerance of Healthy Term Infants to a New Infant Formula
Lead Sponsor:
Abbott Nutrition
Conditions:
Healthy Term Infants
Eligibility:
All Genders
1-11 years
Phase:
PHASE3
Brief Summary
The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.
Eligibility Criteria
Inclusion
- in good health
- singleton full term birth
- Birth weight \> 2490 g.
- Infant is between 0 and 11 days of age
- Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance
- If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
- If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition
- not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study
Exclusion
- adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT01137877
Start Date
May 1 2010
End Date
October 1 2010
Last Update
November 25 2010
Active Locations (20)
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1
Arkansas Children's Hospital Research
Little Rock, Arkansas, United States, 72202
2
Facey Medical Foundation
Mission Hills, California, United States, 91345
3
Norwich Pediatric Group
Norwich, Connecticut, United States, 06360
4
All Women's Healthcare of West Broward, Inc
Plantation, Florida, United States, 33324