Growth and Tolerance of Young Infants Fed Infant Formula

Not Applicable

Completed

• Conditions: Growth and Tolerance

• Registration Number: NCT04105686
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-26
• Study Start: 2019-09-30
• Primary Completion: 2020-12-04
• Study Completion: 2020-12-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight	Day of life 14 to Day of life 119	Weight gain per day

Secondary Outcome Measures

Name	Time	Method
Stool Characteristics	Study Day 1 to Day of life 119	Parent completed diary
Head Circumference (HC)	Day of life 14 to Day of life 119	HC gain per day
Length	Day of life 14 to Day of life 119	Length gain per day
Formula Tolerance	Study Day 1 to Day of life 119	Parent completed diary

Trial Locations

Locations (32)

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

Score Physician Alliance, LLC; 🇺🇸 Saint Petersburg, Florida, United States

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