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Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

Newborn Clinical Trial

Official title:
Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

Clinical Trial Summary

The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04218929
Study type Interventional
Source ByHeart
Contact
Status Completed
Phase N/A
Start date December 10, 2019
Completion date June 11, 2021
View Details
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