Growth and Tolerance of Young Infants Fed Infant Formula
NCT ID: NCT04105686
Last Updated: 2021-01-25
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
366 participants
INTERVENTIONAL
2019-09-30
2020-12-04
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 study product
Control Infant Formula
Ready to feed infant formula, feed ad libitum
Experimental Infant Formula
Milk-based study product with oligosaccharides
Experimental Infant Formula
Ready to feed infant formula, feed ad libitum
Reference Group
Human milk-fed group
No interventions assigned to this group
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
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
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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Central Research Associates
Birmingham, Alabama, United States
Southeastern Pediatric Associates
Dothan, Alabama, United States
Visions Clinical Research
Tucson, Arizona, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
TOPAZ Clinical Research, Inc.
Apopka, Florida, United States
University Clinical Research-Deland, LLC dba Avail Clinical Research- West Volusia Pediatrics
DeLand, Florida, United States
Children's Research, LLC
Lake Mary, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Pediatric & Adult Research Center
Orlando, Florida, United States
Asclepes Research Centers
Spring Hill, Florida, United States
Score Physician Alliance, LLC
St. Petersburg, Florida, United States
PAS Research, LLC
Tampa, Florida, United States
Tekton Research
Chamblee, Georgia, United States
Saltzer Health
Nampa, Idaho, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
Springs Medical Research
Owensboro, Kentucky, United States
Meridian Clinical Research 3080
Baton Rouge, Louisiana, United States
Meridan Clinical Research
Omaha, Nebraska, United States
Wake Research - Clinical Research Center of Nevada
Las Vegas, Nevada, United States
ClinOhio Research Services
Columbus, Ohio, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
PriMed Clinical Research
Dayton, Ohio, United States
Institute of Clinical Research, LLC
Mentor, Ohio, United States
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio, United States
Midsouth Center for Clinical Research
Memphis, Tennessee, United States
Medical Research Center of Memphis
Memphis, Tennessee, United States
Gadolin Research, LLC
Beaumont, Texas, United States
Women's Hospital at Renaissance - Doctors Hospital at Renaissance
Edinburg, Texas, United States
Mercury Clincial Research, Inc.
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Aspen Clinical Research LLC
Orem, Utah, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States
Countries
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Other Identifiers
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AL31A
Identifier Type: -
Identifier Source: org_study_id
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