Growth and Tolerance of Cow Milk-Based Infant Formulas

Body Weight Clinical Trial

Official title:

Growth and Tolerance of Cow Milk-Based Infant Formulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122654
• Other study ID #: 3380-1
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: January 27, 2012
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 16 Days

Eligibility

Inclusion Criteria:

• Singleton, 12-16 days of age at randomization

• Term infant with birth weight of minimum of 2500 g

• Solely formula fed

• Signed Informed Consent and Protected Health Information

Exclusion Criteria:

• History of underlying metabolic or chronic disease or immunocompromised

• Acute infection

• Feeding difficulties or formula intolerance

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Weight

Locations

Country	Name	City	State
United States	Austin Diagnostic Clinic	Austin	Texas
United States	Central Arkansas Pediatric Clinic	Benton	Arkansas
United States	Birmingham Pediatric Associates	Birmingham	Alabama
United States	Cary Pediatric Center, PA	Cary	North Carolina
United States	Alpha Clinical Research	Clarksville	Tennessee
United States	North Georgia Clinical Research Center/White's Pediatrics	Dalton	Georgia
United States	Southeastern Pediatric Associates	Dothan	Alabama
United States	Innovis Health South University	Fargo	North Dakota
United States	The Jackson Clinic - North Jackson	Jackson	Tennessee
United States	Holston Medical Group	Kingsport	Tennessee
United States	Altamonte Pediatric Associates	Lake Mary	Florida
United States	Arkansas Pediatric Clinic	Little Rock	Arkansas
United States	PTCU/Children & Youth Project	Louisville	Kentucky
United States	Deaconess Clinic Gateway	Newburgh	Indiana
United States	Southwestern Medical Clinic, PC	Niles	Michigan
United States	Norwich Pediatric Group, PC	Norwich	Connecticut
United States	The Center for Human Nutrition	Omaha	Nebraska
United States	Owensboro Pediatrics	Owensboro	Kentucky
United States	Red Lion Pediatrics	Philadelphia	Pennsylvania
United States	Pediatrics East - Alabama Clinical Therapeutics	Pinson	Alabama
United States	Primary Physicians Research, Inc	Pittsburgh	Pennsylvania
United States	Children's Medical Association	Plantation	Florida
United States	Southwestern Medical Clinic P.C.	Stevensville	Michigan
United States	Woburn Pediatric Associates	Woburn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight measured on calibrated infant scale at each study visit
Secondary	Twenty-four hour recall of infant formula intake at each study visit
Secondary	Medically-confirmed adverse events collected throughout the study period
Secondary	Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit
Secondary	Parental Product Assessment Questionnaire completed at Study Visit 2	Assessment of physical properties of product and infant's reaction during consumption.
Secondary	Body Length and Head Circumference measured at each study visit