Growth and Tolerance of Cow Milk-Based Infant Formulas

Completed

• Conditions: Body Weight

• Registration Number: NCT01122654
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-13
• Study Start: 2010-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-27
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight measured on calibrated infant scale at each study visit

Secondary Outcome Measures

Name	Time	Method
Twenty-four hour recall of infant formula intake at each study visit
Medically-confirmed adverse events collected throughout the study period
Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit
Parental Product Assessment Questionnaire completed at Study Visit 2		Assessment of physical properties of product and infant's reaction during consumption.
Body Length and Head Circumference measured at each study visit

Trial Locations

Locations (24)

Birmingham Pediatric Associates; 🇺🇸 Birmingham, Alabama, United States

Southeastern Pediatric Associates; 🇺🇸 Dothan, Alabama, United States

Pediatrics East - Alabama Clinical Therapeutics; 🇺🇸 Pinson, Alabama, United States

Central Arkansas Pediatric Clinic; 🇺🇸 Benton, Arkansas, United States

Arkansas Pediatric Clinic; 🇺🇸 Little Rock, Arkansas, United States

Norwich Pediatric Group, PC; 🇺🇸 Norwich, Connecticut, United States

Altamonte Pediatric Associates; 🇺🇸 Lake Mary, Florida, United States

Children's Medical Association; 🇺🇸 Plantation, Florida, United States

North Georgia Clinical Research Center/White's Pediatrics; 🇺🇸 Dalton, Georgia, United States

Deaconess Clinic Gateway; 🇺🇸 Newburgh, Indiana, United States

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