Growth and Tolerance of Infants Fed Milk-Based Infant Formula
NCT ID: NCT03967132
Last Updated: 2020-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
189 participants
INTERVENTIONAL
2019-06-08
2020-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Control Infant Formula
Milk-based infant formula
Control Infant Formula
Ready to feed infant formula, feed ad libitum
Experimental Infant Formula
Milk-based Infant Formula with oligosaccharides
Experimental Infant Formula
Ready to feed infant formula, feed ad libitum
Reference Group
Human-milk fed
Reference Group
Human milk, breast feeding ad libitum
Interventions
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Control Infant Formula
Ready to feed infant formula, feed ad libitum
Experimental Infant Formula
Ready to feed infant formula, feed ad libitum
Reference Group
Human milk, breast feeding ad libitum
Eligibility Criteria
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Inclusion Criteria
* Singleton from a full-term birth with a gestational age of 37-42 weeks
* Birth weight was \> 2490 g (\~5 lbs. 8 oz.)
* If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.
* If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7.
* Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
* Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.
Exclusion Criteria
* Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
* Participant participates in another study that has not been approved as a concomitant study by AN.
14 Days
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Timberly Williams, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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Watching Over Mothers & Babies
Tucson, Arizona, United States
Pediatric Medical Associates
Sacramento, California, United States
Norwich Pediatric Group, P.C.
Norwich, Connecticut, United States
Phoenix Medical Research LLC
Miami, Florida, United States
University Clinical Research-Deland, LLC a/b/a Accel Clinical Research
Orlando, Florida, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
Michael W. Simon, M.D., PSC
Nicholasville, Kentucky, United States
Springs Medical Research
Owensboro, Kentucky, United States
Institute of Clinical Research, LLC
Mentor, Ohio, United States
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio, United States
Holston Medical Group
Kingsport, Tennessee, United States
Midsouth Center for Clinical Research
Memphis, Tennessee, United States
ARC Clinical Research at Wilson Parke
Austin, Texas, United States
Ventavia Research Group, LLC
Fort Worth, Texas, United States
Ventavia Research Group
Houston, Texas, United States
Ventavia Research Group, LLC 3078
Keller, Texas, United States
Kagan Pediatrics - HD Research Corporation
Pearland, Texas, United States
Plano Pediatrics - ACRC Trials
Plano, Texas, United States
Countries
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Other Identifiers
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AL29A
Identifier Type: -
Identifier Source: org_study_id
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