Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas
- Conditions
- Infant Development
- Interventions
- Other: Infant Formula
- Registration Number
- NCT05947084
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 440
- Healthy Term Infant
- Any health condition that would negatively impact infant feeding and growth.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Formula 2_Goat Milk Infant Formula Infant Formula Infant Formula meets all nutrient requirements of the FDA. Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein Infant Formula Infant Formula meets all nutrient requirements of the FDA. Study Formula 4_USDA Organic iron fortified infant formula Infant Formula Infant Formula meets all nutrient requirements of the FDA. Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula Infant Formula Infant formula meets all nutrient requirements of the FDA.
- Primary Outcome Measures
Name Time Method Weight gain (g) from study entry to 16 weeks of study. 16 weeks of Clinical Study Growth Monitoring Study
- Secondary Outcome Measures
Name Time Method Recumbent length gain (cm) from study entry to 16 weeks of study. 16 weeks of Clinical Study Growth Monitoring Study
Tolerance of study formulas over 16 weeks of study 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.
Head Circumference gain (cm) from study entry to 16 weeks of study 16 weeks of Clinical Study Growth Monitoring Study
Trial Locations
- Locations (29)
Velocity Clinical Research-Phoenix
🇺🇸Phoenix, Arizona, United States
Advance Pediatric Associates
🇺🇸Centennial, Colorado, United States
Symphony Clinical Research
🇺🇸Jacksonville, Florida, United States
Clintheory Healthcare Miami
🇺🇸North Miami Beach, Florida, United States
PAS Research Tampa
🇺🇸Tampa, Florida, United States
UpTo Trials
🇺🇸Tampa, Florida, United States
Backtee Holdings, LLC
🇺🇸Wellington, Florida, United States
Velocity Clinical Research-Macon
🇺🇸Macon, Georgia, United States
Leavitt Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Kentucky Pediatric Research
🇺🇸Bardstown, Kentucky, United States
Springs Medical Research
🇺🇸Owensboro, Kentucky, United States
Magnolia Clinical Research, LLC
🇺🇸Lutcher, Louisiana, United States
Velocity Clinical Research-Slidell, LA
🇺🇸Slidell, Louisiana, United States
Frontier Pediatric Research, LLC
🇺🇸Lincoln, Nebraska, United States
PAS Research Henderson
🇺🇸Henderson, Nevada, United States
PAS Research Vegas
🇺🇸Las Vegas, Nevada, United States
Velocity Clinical Research-Durham
🇺🇸Durham, North Carolina, United States
Hightower Clinical-Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Hightower Clinical-Shawnee
🇺🇸Shawnee, Oklahoma, United States
Cyn3rgy
🇺🇸Gresham, Oregon, United States
PAS Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Coastal Ped Research-Charleston
🇺🇸Charleston, South Carolina, United States
Coastal Ped Research-Summerville
🇺🇸Summerville, South Carolina, United States
AVIATI Healthcare & Clinical Research
🇺🇸Memphis, Tennessee, United States
Helios Clinical Research-Burleson
🇺🇸Burleson, Texas, United States
Helios Clinical Research-Houston
🇺🇸Houston, Texas, United States
Prime Clinical Research, Inc
🇺🇸Mansfield, Texas, United States
PAS Research McAllen
🇺🇸McAllen, Texas, United States
Helios Clinical Research-Weatherford
🇺🇸Weatherford, Texas, United States