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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Keith A Aqua, MD 561 231 5028 KAqua@acrcfl.com
Contact: Patrick McCarthy, JD 303 901 7407 pmccarthy@validcare.com

Locations
Show Show 34 study locations
Sponsors and Collaborators
Aussie Bubs, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Keith Aqua, MD Backtee Holdings, LLC
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No