Growth and Tolerance of Young Infants Fed Infant Formula

Completed · Not applicable

Conditions studied: Growth and Tolerance

In brief

This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.

Key facts

Study ID

NCT04105686

Run by

Abbott Nutrition

People needed

366

Starts

2019-09-30

Expected to finish

2020-12-04

Last updated by the study team

2021-01-25

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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