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

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

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.

Study Overview

• Status: Completed
• Conditions: Infant Development
• Intervention / Treatment: Other: Infant Formula

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.

• Study Type: Interventional
• Enrollment (Actual): 518
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Velocity Clinical Research-Phoenix
  • Colorado
    • Centennial, Colorado, United States, 80015
      • Advance Pediatric Associates
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Symphony Clinical Research
    • North Miami Beach, Florida, United States, 33162
      • Clintheory Healthcare Miami
    • Tampa, Florida, United States, 33607
      • PAS Research Tampa
    • Tampa, Florida, United States, 33612
      • UpTo Trials
    • Wellington, Florida, United States, 33414
      • Backtee Holdings, LLC
  • Georgia
    • Macon, Georgia, United States, 31210
      • Velocity Clinical Research-Macon
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Leavitt Clinical Research
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric Research
    • Owensboro, Kentucky, United States, 42303
      • Springs Medical Research
  • Louisiana
    • Lutcher, Louisiana, United States, 70071
      • Magnolia Clinical Research, Llc
    • Slidell, Louisiana, United States, 70458
      • Velocity Clinical Research-Slidell, LA
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Frontier Pediatric Research, LLC
  • Nevada
    • Henderson, Nevada, United States, 89014
      • PAS Research Henderson
    • Las Vegas, Nevada, United States, 89128
      • PAS Research Vegas
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Velocity Clinical Research-Durham
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73114
      • Hightower Clinical-Oklahoma City
    • Shawnee, Oklahoma, United States, 74804
      • Hightower Clinical-Shawnee
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Cyn3rgy
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15227
      • PAS Pittsburgh
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Ped Research-Charleston
    • Summerville, South Carolina, United States, 29486
      • Coastal Ped Research-Summerville
  • Tennessee
    • Memphis, Tennessee, United States, 38115
      • AVIATI Healthcare & Clinical Research
  • Texas
    • Burleson, Texas, United States, 76028
      • Helios Clinical Research-Burleson
    • Houston, Texas, United States, 77008
      • Helios Clinical Research-Houston
    • Mansfield, Texas, United States, 76063
      • Prime Clinical Research, Inc
    • McAllen, Texas, United States, 78504
      • PAS Research McAllen
    • Weatherford, Texas, United States, 76086
      • Helios Clinical Research-Weatherford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy Term Infant

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula; Infant formula meets all nutrient requirements of the FDA.	Other: Infant Formula; Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period
Experimental: Study Formula 2_Goat Milk Infant Formula; Infant Formula meets all nutrient requirements of the FDA.	Other: Infant Formula; Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period
Experimental: Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein; Infant Formula meets all nutrient requirements of the FDA.	Other: Infant Formula; Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period
Active Comparator: Study Formula 4_USDA Organic iron fortified infant formula; Infant Formula meets all nutrient requirements of the FDA.	Other: Infant Formula; Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain (g) from study entry to 16 weeks of study.	Growth Monitoring Study	16 weeks of Clinical Study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recumbent length gain (cm) from study entry to 16 weeks of study.	Growth Monitoring Study	16 weeks of Clinical Study
Head Circumference gain (cm) from study entry to 16 weeks of study	Growth Monitoring Study	16 weeks of Clinical Study
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

Collaborators and Investigators

• Sponsor: Aussie Bubs, Inc.
• Collaborators: Validcare
• Investigators: Principal Investigator: Keith Aqua, MD, Backtee Holdings, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Actual): April 19, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BubsGMS_2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No