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NCT05947084 Clinical Trial

Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas

Infant Development Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05947084
Other study ID # BubsGMS_2023
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 31, 2023
Est. completion date September 13, 2024

Study information
Verified date April 2024
Source Aussie Bubs, Inc.
Contact Keith A Aqua, MD
Phone 561 231 5028
Email KAqua@acrcfl.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 440
Est. completion date September 13, 2024
Est. primary completion date August 9, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 14 Days
Eligibility Inclusion Criteria: - Healthy Term Infant Exclusion Criteria: - Any health condition that would negatively impact infant feeding and growth.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Infant Formula
Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period

Locations
Country Name City State
United States Velocity Clinical Research-Austin, TX Austin Texas
United States Kentucky Pediatric Research Bardstown Kentucky
United States Helios Clinical Research-Burleson Burleson Texas
United States Advance Pediatric Associates Centennial Colorado
United States Coastal Ped Research-Charleston Charleston South Carolina
United States PAS Clearwater Clearwater Florida
United States Velocity Clinical Research-Durham Durham North Carolina
United States Cyn3rgy Gresham Oregon
United States Velocity Clinical Research-Gulfport Gulfport Mississippi
United States PAS Research Henderson Henderson Nevada
United States Helios Clinical Research-Houston Houston Texas
United States Leavitt Clinical Research Idaho Falls Idaho
United States Symphony Clinical Research Jacksonville Florida
United States Altus Research-Florida Lake Worth Florida
United States PAS Research Vegas Las Vegas Nevada
United States Frontier Pediatric Research, LLC Lincoln Nebraska
United States Magnolia Clinical Research, LLC Lutcher Louisiana
United States Velocity Clinical Research-Macon Macon Georgia
United States Prime Clinical Research, Inc Mansfield Texas
United States PAS Research McAllen McAllen Texas
United States AVIATI Healthcare & Clinical Research Memphis Tennessee
United States Velocity Clinical Research-Mobile, AL Mobile Alabama
United States Clintheory Healthcare Miami North Miami Beach Florida
United States Hightower Clinical-Oklahoma City Oklahoma City Oklahoma
United States Springs Medical Research Owensboro Kentucky
United States Velocity Clinical Research-Phoenix Phoenix Arizona
United States PAS Pittsburgh Pittsburgh Pennsylvania
United States Hightower Clinical-Shawnee Shawnee Oklahoma
United States Velocity Clinical Research-Slidell, LA Slidell Louisiana
United States Coastal Ped Research-Summerville Summerville South Carolina
United States PAS Research Tampa Tampa Florida
United States UpTo Trials Tampa Florida
United States Helios Clinical Research-Weatherford Weatherford Texas
United States Backtee Holdings, LLC Wellington Florida

Sponsors (1)
Lead Sponsor Collaborator
Aussie Bubs, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight gain (g) from study entry to 16 weeks of study. Growth Monitoring Study 16 weeks of Clinical Study
Secondary Recumbent length gain (cm) from study entry to 16 weeks of study. Growth Monitoring Study 16 weeks of Clinical Study
Secondary Head Circumference gain (cm) from study entry to 16 weeks of study Growth Monitoring Study 16 weeks of Clinical Study
Secondary Tolerance of study formulas over 16 weeks of study Tolerance of the infant to the study formulas will be evaluated 5 times through the use of study diaries for 3 days before each study visit. 16 weeks of Clinical Study
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