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

NCT04389606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2021-07-21

No results posted yet for this study

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 group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.

Conditions

  • Healthy
  • Term Infants

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
16 Weeks
Max Age
19 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-12
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 NCT04389606 on ClinicalTrials.gov