Status:
COMPLETED
Growth and Tolerance of Young Infants Fed Infant Formula
Lead Sponsor:
Abbott Nutrition
Conditions:
Growth and Tolerance
Eligibility:
All Genders
Up to 14 years
Phase:
NA
Brief Summary
This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.
Eligibility Criteria
Inclusion
- Participant is judged to be in good health as determined from participant's medical history.
- Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
- Participant's birth weight was \> 2490 g (\~5 lbs. 8 oz.).
- Parent(s) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study.
- Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study.
- Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
- Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable).
- Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or applicable privacy regulation) authorization prior to any participation in the study.
Exclusion
- An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Participant is taking and plans to continue taking medications (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance.
- Participant participates in another study that has not been approved as a concomitant study.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2020
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT04105686
Start Date
September 30 2019
End Date
December 4 2020
Last Update
January 25 2021
Active Locations (32)
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1
Central Research Associates
Birmingham, Alabama, United States, 35205
2
Southeastern Pediatric Associates
Dothan, Alabama, United States, 36305
3
Visions Clinical Research
Tucson, Arizona, United States, 85712
4
Applied Research Center of Arkansas
Little Rock, Arkansas, United States, 72212