The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Bubs Growth Monitoring Study
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05947084
Recruitment Status : Recruiting
First Posted : July 17, 2023
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Aussie Bubs, Inc.

Tracking Information
First Submitted Date  ICMJE June 27, 2023
First Posted Date  ICMJE July 17, 2023
Last Update Posted Date April 26, 2024
Actual Study Start Date  ICMJE August 31, 2023
Estimated Primary Completion Date August 9, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2023)		 Weight gain (g) from study entry to 16 weeks of study. [ Time Frame: 16 weeks of Clinical Study ]
Growth Monitoring Study
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2023)
  • Recumbent length gain (cm) from study entry to 16 weeks of study. [ Time Frame: 16 weeks of Clinical Study ]
    Growth Monitoring Study
  • Head Circumference gain (cm) from study entry to 16 weeks of study [ Time Frame: 16 weeks of Clinical Study ]
    Growth Monitoring Study
  • Tolerance of study formulas over 16 weeks of study [ Time Frame: 16 weeks of Clinical 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas
Official Title  ICMJE Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas. A 4 Month, Prospective, Randomized, Multi Center Clinical Trial.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomization and exclusive feeding of study formulas by 14 days of age. Breastfed Cohort will be evaluated over the 16 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Study infant formulas have been blinded
Primary Purpose: Other
Condition  ICMJE Infant Development
Intervention  ICMJE Other: Infant Formula
Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period
Study Arms  ICMJE
  • Experimental: Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula
    Infant formula meets all nutrient requirements of the FDA.
    Intervention: Other: Infant Formula
  • Experimental: Study Formula 2_Goat Milk Infant Formula
    Infant Formula meets all nutrient requirements of the FDA.
    Intervention: Other: Infant Formula
  • Experimental: Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein
    Infant Formula meets all nutrient requirements of the FDA.
    Intervention: Other: Infant Formula
  • Active Comparator: Study Formula 4_USDA Organic iron fortified infant formula
    Infant Formula meets all nutrient requirements of the FDA.
    Intervention: Other: Infant Formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2023)		 440
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 13, 2024
Estimated Primary Completion Date August 9, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy Term Infant

Exclusion Criteria:

  • Any health condition that would negatively impact infant feeding and growth.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Day to 14 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Keith A Aqua, MD 561 231 5028 KAqua@acrcfl.com
Contact: Patrick McCarthy, JD 303 901 7407 pmccarthy@validcare.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05947084
Other Study ID Numbers  ICMJE BubsGMS_2023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Aussie Bubs, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aussie Bubs, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Keith Aqua, MD Backtee Holdings, LLC
PRS Account Aussie Bubs, Inc.
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP