Growth and Tolerance of Young Infants Fed Infant Formulas

Infant Newborn Clinical Trial

Official title:

Growth and Tolerance of Young Infants Fed Infant Formulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380886
• Other study ID #: AK92
• Status: Completed
• Phase: Phase 3
• First received: June 16, 2011
• Last updated: February 14, 2013
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 8 Days

Eligibility

Inclusion Criteria:

• healthy infant

• full term

• birth weight > 2490 g

• 0 to 8 days of age

• parent/physician agree to not use medications affecting tolerance/growth

• parent agrees to sole source feeding of study formula

• parent agrees to not use vitamin/mineral supplements

• parent has signed consent/HIPAA authorization

Exclusion Criteria:

• any maternal, fetal, or infant history affecting growth and tolerance

• participation in any other study not preapproved by Abbott

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infant Newborn

Intervention

Other:
• experimental infant formula with alternate protein source
experimental infant formula to be fed ad libitum
• Infant formula powder
powdered infant formula to be fed ad libitum

Locations

Country	Name	City	State
United States	Cary Pediatric Center	Cary	North Carolina
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Ohio Pediatric Research Association, INC.	Huber Heights	Ohio
United States	Northpoint Pedicatrics, LLC	Indianapolis	Indiana
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Institute of Clinical Research	Mayfield Heights	Ohio
United States	Norwich Pediatric Group, PC	Norwich	Connecticut
United States	Springs Medical Research, LLC	Owensboro	Kentucky
United States	The Cleveland Pediatric Research Center	Parma	Ohio
United States	Sanford Clinic Family Medicine	Sioux Falls	South Dakota
United States	SCORE Physician Alliance, LLC	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain		119 days	No
Secondary	gastrointestinal tolerance	Stool characteristics, number of stools per day, and number of feedings associated with spit up or vomit	119 days	No
Secondary	Anthropometric variables	Length gain per day and head circumference gain per day	119 days	No