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Trial record 1 of 1 for:    Bubs Growth Monitoring Study
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Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas

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ClinicalTrials.gov Identifier: NCT05947084
Recruitment Status : Recruiting
First Posted : July 17, 2023
Last Update Posted : December 22, 2023
Sponsor:
Information provided by (Responsible Party):
Aussie Bubs, Inc.

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.

Condition or disease Intervention/treatment Phase
Infant Development Other: Infant Formula Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
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
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.
Actual Study Start Date : August 31, 2023
Estimated Primary Completion Date : August 9, 2024
Estimated Study Completion Date : September 13, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Weight gain (g) from study entry to 16 weeks of study. [ Time Frame: 16 weeks of Clinical Study ]
    Growth Monitoring Study


Secondary Outcome Measures :
  1. Recumbent length gain (cm) from study entry to 16 weeks of study. [ Time Frame: 16 weeks of Clinical Study ]
    Growth Monitoring Study

  2. Head Circumference gain (cm) from study entry to 16 weeks of study [ Time Frame: 16 weeks of Clinical Study ]
    Growth Monitoring Study

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Day to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Term Infant

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05947084


Contacts
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Contact: Keith A Aqua, MD 561 231 5028 KAqua@acrcfl.com
Contact: Patrick McCarthy, JD 303 901 7407 pmccarthy@validcare.com

Locations
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Sponsors and Collaborators
Aussie Bubs, Inc.
Investigators
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Principal Investigator: Keith Aqua, MD Backtee Holdings, LLC
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Responsible Party: Aussie Bubs, Inc.
ClinicalTrials.gov Identifier: NCT05947084    
Other Study ID Numbers: BubsGMS_2023
First Posted: July 17, 2023    Key Record Dates
Last Update Posted: December 22, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No