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

Last updated: April 29, 2025
Sponsor: Aussie Bubs, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Infant Formula

Clinical Study ID

NCT05947084
BubsGMS_2023
  • Ages 1-14
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy Term Infant

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 440
Treatment Group(s): 1
Primary Treatment: Infant Formula
Phase: 3
Study Start date:
August 31, 2023
Estimated Completion Date:
June 30, 2025

Study Description

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

Connect with a study center

  • Velocity Clinical Research-Mobile, AL

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Velocity Clinical Research-Phoenix

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Advance Pediatric Associates

    Centennial, Colorado 80015
    United States

    Site Not Available

  • Advanced Pediatric Associates

    Centennial, Colorado 80015
    United States

    Active - Recruiting

  • PAS Clearwater

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Symphony Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Altus Research-Florida

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • Altus Research-Florida

    Miami, Florida 33461
    United States

    Site Not Available

  • Clintheory Healthcare Miami

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Backtee Holdings, LLC

    Palm Beach, Florida 33480
    United States

    Site Not Available

  • PAS Research Tampa

    Tampa, Florida 33607
    United States

    Site Not Available

  • PAS Tampa

    Tampa, Florida 33607
    United States

    Site Not Available

  • UpTo Trials

    Tampa, Florida 33612
    United States

    Site Not Available

  • Backtee Holdings, LLC

    Wellington, Florida 33414
    United States

    Site Not Available

  • Velocity Clinical Research-Macon

    Macon, Georgia 31210
    United States

    Site Not Available

  • Leavitt Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Kentucky Pediatric Research

    Bardstown, Kentucky 40004
    United States

    Site Not Available

  • Springs Medical Research

    Owensboro, Kentucky 42303
    United States

    Site Not Available

  • Magnolia Clinical Research, LLC

    Lutcher, Louisiana 70071
    United States

    Site Not Available

  • Velocity Clinical Research-Slidell, LA

    Slidell, Louisiana 70458
    United States

    Site Not Available

  • Velocity Clinical Research-Gulfport

    Gulfport, Mississippi 39503
    United States

    Site Not Available

  • Frontier Pediatric Research, LLC

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • PAS Research

    Henderson, Nevada 89014
    United States

    Active - Recruiting

  • PAS Research Henderson

    Henderson, Nevada 89014
    United States

    Site Not Available

  • PAS Research

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • PAS Research Vegas

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Velocity Clinical Research-Durham

    Durham, North Carolina 27701
    United States

    Site Not Available

  • Hightower Clinical

    Oklahoma City, Oklahoma 73114
    United States

    Active - Recruiting

  • Hightower Clinical-Oklahoma City

    Oklahoma City, Oklahoma 73114
    United States

    Site Not Available

  • Hightower Clinical-Shawnee

    Shawnee, Oklahoma 74804
    United States

    Site Not Available

  • Cyn3rgy

    Gresham, Oregon 97030
    United States

    Site Not Available

  • Cyn3rgy Research

    Gresham, Oregon 97030
    United States

    Active - Recruiting

  • PAS Pittsburgh

    Pittsburgh, Pennsylvania 15227
    United States

    Site Not Available

  • Coastal Ped Research-Charleston

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Coastal Ped Research-Summerville

    Summerville, South Carolina 29486
    United States

    Site Not Available

  • AVIATI Healthcare & Clinical Research

    Memphis, Tennessee 38115
    United States

    Site Not Available

  • Velocity Clinical Research-Austin, TX

    Austin, Texas 78613
    United States

    Site Not Available

  • Helios Clinical Research-Burleson

    Burleson, Texas 76028
    United States

    Site Not Available

  • Helios Clinical Research-Houston

    Houston, Texas 77008
    United States

    Site Not Available

  • Prime Clinical Research, Inc

    Mansfield, Texas 76063
    United States

    Site Not Available

  • PAS Research

    McAllen, Texas 78504
    United States

    Active - Recruiting

  • PAS Research McAllen

    McAllen, Texas 78504
    United States

    Site Not Available

  • Helios Clinical Research-Weatherford

    Weatherford, Texas 76086
    United States

    Site Not Available

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