Clinical trial NCT05947084: Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Infant Development
Lead sponsor: Aussie Bubs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Validcare CRO
First posted: 2023-07-17
Enrollment: 440
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization and exclusive feeding of study formulas by 14 days of age. Breastfed Cohort will be evaluated over the 16 weeks.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Healthy Term Infant

Exclusion Criteria:

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

Primary outcomes:
measure: Weight gain (g) from study entry to 16 weeks of study.
timeFrame: 16 weeks of Clinical Study
Secondary outcomes:
measure: Recumbent length gain (cm) from study entry to 16 weeks of study.
timeFrame: 16 weeks of Clinical Study
measure: Head Circumference gain (cm) from study entry to 16 weeks of study
timeFrame: 16 weeks of Clinical Study
measure: Tolerance of study formulas over 16 weeks of study
timeFrame: 16 weeks of Clinical Study
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Velocity Clinical Research-Phoenix
state: Arizona
city: Centennial
country: United States
facility: Advance Pediatric Associates
state: Colorado
city: Jacksonville
country: United States
facility: Symphony Clinical Research
state: Florida
city: North Miami Beach
country: United States
facility: Clintheory Healthcare Miami
state: Florida
city: Tampa
country: United States
facility: PAS Research Tampa
state: Florida
city: Tampa
country: United States
facility: UpTo Trials
state: Florida
city: Wellington
country: United States
facility: Backtee Holdings, LLC
state: Florida
city: Macon
country: United States
facility: Velocity Clinical Research-Macon
state: Georgia
city: Idaho Falls
country: United States
facility: Leavitt Clinical Research
state: Idaho
city: Bardstown
country: United States
facility: Kentucky Pediatric Research
state: Kentucky
city: Owensboro
country: United States
facility: Springs Medical Research
state: Kentucky
city: Lutcher
country: United States
facility: Magnolia Clinical Research, LLC
state: Louisiana
city: Slidell
country: United States
facility: Velocity Clinical Research-Slidell, LA
state: Louisiana
city: Lincoln
country: United States
facility: Frontier Pediatric Research, LLC
state: Nebraska
city: Henderson
country: United States
facility: PAS Research Henderson
state: Nevada
city: Las Vegas
country: United States
facility: PAS Research Vegas
state: Nevada
city: Durham
country: United States
facility: Velocity Clinical Research-Durham
state: North Carolina
city: Oklahoma City
country: United States
facility: Hightower Clinical-Oklahoma City
state: Oklahoma
city: Shawnee
country: United States
facility: Hightower Clinical-Shawnee
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy
state: Oregon
city: Pittsburgh
country: United States
facility: PAS Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Ped Research-Charleston
state: South Carolina
city: Summerville
country: United States
facility: Coastal Ped Research-Summerville
state: South Carolina
city: Memphis
country: United States
facility: AVIATI Healthcare & Clinical Research
state: Tennessee
city: Burleson
country: United States
facility: Helios Clinical Research-Burleson
state: Texas
city: Houston
country: United States
facility: Helios Clinical Research-Houston
state: Texas
city: Mansfield
country: United States
facility: Prime Clinical Research, Inc
state: Texas
city: McAllen
country: United States
facility: PAS Research McAllen
state: Texas
city: Weatherford
country: United States
facility: Helios Clinical Research-Weatherford
state: Texas
Study officials:
affiliation: Backtee Holdings, LLC
name: Keith Aqua, MD
role: PRINCIPAL_INVESTIGATOR
References: