Status:

COMPLETED

Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

Lead Sponsor:

ByHeart

Collaborating Sponsors:

Paidion Research, Inc.

Conditions:

Healthy

Term Infants

Eligibility:

All Genders

16-19 years

Phase:

NA

Brief Summary

The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference...

Eligibility Criteria

Inclusion

  • Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Exclusion

  • Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Key Trial Info

Start Date :

May 12 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 11 2021

Estimated Enrollment :

311 Patients enrolled

Trial Details

Trial ID

NCT04389606

Start Date

May 12 2020

End Date

June 11 2021

Last Update

July 21 2021

Active Locations (27)

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Page 1 of 7 (27 locations)

1

Alabama Clinical Therapeutics

Birmingham, Alabama, United States, 35126

2

Watching Over Mothers and Babies

Tucson, Arizona, United States, 85712

3

The Children's Clinic of Jonesboro, P.A.

Jonesboro, Arkansas, United States, 72401

4

Applied Research Center of Arkansas

Little Rock, Arkansas, United States, 72212