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NCT02860026 Clinical Trial

Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas

Growth Clinical Trial

Official title:
Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02860026
Other study ID # 3388-1
Secondary ID
Status Withdrawn
Phase N/A
First received August 3, 2016
Last updated May 26, 2017
Start date October 2016
Est. completion date April 2018

Study information
Verified date May 2017
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 14 Days
Eligibility Inclusion Criteria:

- Singleton 10-14 days of age at randomization

- Term infant with birth weight of minimum of 2500 grams

- Solely formula fed

- Signed informed consent and protected health information

Exclusion Criteria:

- History of underlying metabolic or chronic disease, anemia, or immune compromise

- Feeding difficulties or formula intolerance

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Marketed cow's milk-based infant formula

• Cow's milk-based infant formula with added nutrients

Locations
Country Name City State
United States Kentucky Pediatrics/Adult Research Bardstown Kentucky
United States Birmingham Pediatric Associates Birmingham Alabama
United States Coastal Pediatric Research Charleston South Carolina
United States Pediatric Associates of Mt. Carmel, Inc. Cincinnati Ohio
United States Ohio Pediatric Research Association Dayton Ohio
United States Southeastern Pediatric Associates Dothan Alabama
United States Deaconess Clinical Research Evansville Indiana
United States Pediatric Associates of Fairfield, Inc. Fairfield Ohio
United States Northwest Arkansas Pediatric Clinic Fayetteville Arkansas
United States The Jackson Clinic - North Jackson Jackson Tennessee
United States The Children's Clinic of Jonesboro, P.A. Jonesboro Arkansas
United States Holston Medical Group Kingsport Tennessee
United States Altamonte Pediatric Associates Lake Mary Florida
United States DCOL Center for Clinical Research Longview Texas
United States Norwich Pediatric Group, P.C. Norwich Connecticut
United States Owensboro Pediatrics Owensboro Kentucky
United States UHMP Comprehensive Pediatrics Westlake Ohio

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 Rate of body weight gain from 14 to 120 days of age 3.5 months
Secondary Recall of infant formula at each study visit Up to 3.5 months
Secondary Body length measured at each study visit Up to 3.5 months
Secondary Recall of stool characteristics questionnaire measured at each study visit Up to 3.5 months
Secondary Head circumference measured at each study visit Up to 3.5 months
Secondary Recall of gastrointestinal tolerance questionnaire at each study visit Up to 3.5 months
Secondary Medically confirmed adverse events collected throughout the study period Up to 3.5 months
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