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Iron-Fortified Formula for Infant Development

Phase 3
Recruiting
Led By Keith Aqua, MD
Research Sponsored by Aussie Bubs, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks of clinical study
Awards & highlights

Study Summary

This trial will study weight gain in healthy babies over 4 months when fed iron-fortified formula.

Who is the study for?
This trial is for healthy babies born at full term. It's not suitable for infants with health issues that could affect how they feed or grow.Check my eligibility
What is being tested?
The study tests the growth effects of iron-fortified infant formula over a period of 4 months, monitoring weight gain and overall development in these infants.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include digestive discomfort or allergic reactions to ingredients in the formula.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks of clinical study
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks of clinical study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight gain (g) from study entry to 16 weeks of study.
Secondary outcome measures
Head Circumference gain (cm) from study entry to 16 weeks of study
Recumbent length gain (cm) from study entry to 16 weeks of study.
Tolerance of study formulas over 16 weeks of study

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCaseinExperimental Treatment1 Intervention
Infant Formula meets all nutrient requirements of the FDA.
Group II: Study Formula 2_Goat Milk Infant FormulaExperimental Treatment1 Intervention
Infant Formula meets all nutrient requirements of the FDA.
Group III: Study Formula 1_365 Day Grass-Fed Cow's Milk Infant FormulaExperimental Treatment1 Intervention
Infant formula meets all nutrient requirements of the FDA.
Group IV: Study Formula 4_USDA Organic iron fortified infant formulaActive Control1 Intervention
Infant Formula meets all nutrient requirements of the FDA.

Find a Location

Who is running the clinical trial?

Aussie Bubs, Inc.Lead Sponsor
Keith Aqua, MDPrincipal InvestigatorBacktee Holdings, LLC
1 Previous Clinical Trials
570 Total Patients Enrolled

Media Library

Infant Formula (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05947084 — Phase 3
Infant Development Research Study Groups: Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula, Study Formula 2_Goat Milk Infant Formula, Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein, Study Formula 4_USDA Organic iron fortified infant formula
Infant Development Clinical Trial 2023: Infant Formula Highlights & Side Effects. Trial Name: NCT05947084 — Phase 3
Infant Formula (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05947084 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 50 and above eligible for enrollment in this medical trial?

"To be considered eligible for this study, participants must fall between 1 Day and 14 Days of age."

Answered by AI

What are the prerequisites for partaking in this experiment?

"This study is seeking 440 neonates aged 1 Day to 14 Days for infant development research. The primary requirement of applicants is that they must be healthy, term infants."

Answered by AI

Is this scientific experiment currently recruiting participants?

"Clinicaltrials.gov confirms that this particular study is not presently accepting participants, having been published on the 31st of July 2023 and last updated during the same month. However, there are 38 other trials actively recruiting right now."

Answered by AI

Has the FDA validated that Study Formula 3_Cow's Milk Infant Formula is free of A1-BetaCasein?

"Our team at Power rated Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein as a level 3 on the safety scale since it is in Phase 3 and there have been multiple rounds of data confirming its efficacy and security."

Answered by AI

Are there multiple facilities conducting this trial within the state's borders?

"Backtee Holdings LLC in Palm Beach, PAS Tampa in Tampa, and Hightower Clinical in Oklahoma City are three of the four medical sites that are currently recruiting for this trial. Additional locations also exist."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas
2023. "Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05947084.
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~120 spots leftby Aug 2024
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