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

NCT04218929 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2021-06-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Paidion Research, Inc.

    collaborator INDUSTRY

  • ByHeart

    lead INDUSTRY

Principal Investigators

  • Devon Kuehn, MD · ByHeart, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-10
Primary Completion
2021-06-11
Completion
2021-06-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04218929 on ClinicalTrials.gov