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Growth and Tolerance of Infants Fed Infant Formulas

Growth and Tolerance of Young Infants Fed Infant Formulas

NCT01808105•Abbott Nutrition

Summary

To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Singleton from full term birth with a gestational age 37-42 weeks
•Birth weight \> 2490 g (\~5 lbs 8 oz)
•Between 0 and 5 days of age
•Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
•Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
•Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study
•No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional

Exclusion Criteria

•Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development
•Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
•Treatment with antibiotics
•Mother intends to use a combination of breast and formula feeding

Locations (25)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

Alabama Clinical Therapeutics

Dothan, Alabama, United States

W.O.M.B Watching Over Mothers and Babies

Tucson, Arizona, United States

Clinical Research Advantage/Colorado Springs Health Partners

Colorado Springs, Colorado, United States

Norwich Pediatric Group, PC

Norwich, Connecticut, United States

Atlantic Clinical Research Collaborative

Boynton Beach, Florida, United States

Lake Mary Pediatrics

Orange City, Florida, United States

SCORE Physician Alliance, LLC

St. Petersburg, Florida, United States

USF, College of Medicine, Dept of Pediatrics

Tampa, Florida, United States

Southeast Regional Research Group (SERRG)

Columbus, Georgia, United States

Key Dates

Start Date

April 1, 2013

Primary Completion Date

February 1, 2014

Completion Date

February 1, 2014

Last Updated

June 2, 2014

Enrollment

424

ACTUAL participants

Conditions

Growth and Tolerance

Interventions

Control Formula

OTHER

Experimental Formula 1

OTHER

Experimental Formula 2

OTHER

Human Milk

OTHER

Nutritional Management of Children With Chronic Diarrhea

NCT01812629

Growth and Tolerance Infant Study

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 2, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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