Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas. A 4 Month, Prospective, Randomized, Multi Center Clinical Trial.

Aussie Bubs, Inc.29 sites in 1 country518 target enrollmentAugust 31, 2023

ConditionsInfant Development

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infant Development
Sponsor: Aussie Bubs, Inc.
Enrollment: 518
Locations: 29
Primary Endpoint: Weight gain (g) from study entry to 16 weeks of study.
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.

Detailed Description

A Growth Monitoring Study conducted according to FDA established guidelines to evaluate the test infant formulas ability to promote normal growth and development.

Registry

clinicaltrials.gov

Start Date

August 31, 2023

End Date

June 30, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aussie Bubs, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy Term Infant

Exclusion Criteria

•Any health condition that would negatively impact infant feeding and growth.

Outcomes

Primary Outcomes

Weight gain (g) from study entry to 16 weeks of study.

Time Frame: 16 weeks of Clinical Study

Growth Monitoring Study

Secondary Outcomes

Recumbent length gain (cm) from study entry to 16 weeks of study.(16 weeks of Clinical Study)
Tolerance of study formulas over 16 weeks of study(16 weeks of Clinical Study)
Head Circumference gain (cm) from study entry to 16 weeks of study(16 weeks of Clinical Study)