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COMPLETEDNANCT03276884

Growth and Tolerance of Young Infants

To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.

Lead sponsor: Abbott Nutrition•22 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Abbott Nutrition

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subject is judged to be in good health.
•Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
•Birth weight was ≥ 2490 g (\~5 lbs. 8 oz.).
•Subject is between 0 and 8 days of age at enrollment.
•Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
•Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study.
•Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.

Exclusion Criteria

•An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
•Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
•Subject participates in another study that has not been approved as a concomitant study.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 3, 2018Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment267

Start dateOct 2017

Last updatedDec 3, 2018

Condition

Locations shown

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama

Southeastern Pediatric Associates

Dothan, Alabama

Watching Over Mothers and Babies

Tucson, Arizona

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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: December 3, 2018Data synced to Clareo: May 3, 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.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions