Status:
COMPLETED
Growth and Tolerance of Young Infants
Lead Sponsor:
Abbott Nutrition
Conditions:
Growth
Eligibility:
All Genders
Up to 8 years
Phase:
NA
Brief Summary
To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.
Eligibility Criteria
Inclusion
- Subject is judged to be in good health.
- Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
- Birth weight was ≥ 2490 g (\~5 lbs. 8 oz.).
- Subject is between 0 and 8 days of age at enrollment.
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
- Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study.
- Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.
Exclusion
- An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
- Subject participates in another study that has not been approved as a concomitant study.
Key Trial Info
Start Date :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2018
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT03276884
Start Date
October 11 2017
End Date
November 8 2018
Last Update
December 3 2018
Active Locations (22)
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1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
Southeastern Pediatric Associates
Dothan, Alabama, United States, 36305
3
Watching Over Mothers and Babies
Tucson, Arizona, United States, 85712
4
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States, 72401