NCT04218929

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 311 (actual)
• Sponsor: ByHeart · Industry
• Sex: All
• Age: 0 Days – 14 Days
• Healthy volunteers: Accepted

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).

Conditions

• Infants
• Newborn

Interventions

Type	Name	Description
OTHER	Study Formula (SF)	New infant formula for term infants fed ad lib
OTHER	Comparator Formula (CF)	Commercially available infant formula for term infants fed ad lib

Timeline

• Start date: 2019-12-10
• Primary completion: 2021-06-11
• Completion: 2021-06-11
• First posted: 2020-01-06
• Last updated: 2021-06-30

Locations

27 sites across 1 country: United States