Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula

Not Applicable

Completed

• Conditions: Healthy Term Infants Solely Formula Fed
• Interventions: Other: Enfamil LIPIL with iron; Other: Good Start Supreme with DHA and ARA

• Registration Number: NCT00666120
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.

Hypothesize there will be no difference between formula groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2008-04
• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2008-04-23
• Last Update Submitted: 2008-04-23
• Study First Posted: 2008-04-24
• Last Update Posted: 2008-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

Inclusion Criteria

• Singleton birth
• Term infant at birth
• Birth weight of 2500 g (5 lbs 8 oz) or more
• 4 - 18 days of age at Study Visit 1

Exclusion Criteria

• History of underlying metabolic or chronic disease or congenital malformation
• Infant switched formulas more than one time between birth and Study Visit 1
• Known feeding problems at Study Visit 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Enfamil LIPIL with iron	Cow's milk based infant formula
2	Good Start Supreme with DHA and ARA	Partially hydrolyzed cow's milk based infant formula

Primary Outcome Measures

Name	Time	Method
Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator	60 days

Secondary Outcome Measures

Name	Time	Method
Infant temperament	60 days

Trial Locations

Locations (18)

Mercy Rogers Pediatric Clinic; 🇺🇸 Rogers, Arkansas, United States

Pediatrics Clinical Trials Unit; 🇺🇸 Louisville, Kentucky, United States

Collom and Carney Clinic; 🇺🇸 Texarkana, Texas, United States

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

Welborn Clinic; 🇺🇸 Evansville, Indiana, United States

Heartland Research Associates; 🇺🇸 Wichita, Kansas, United States

Winthrop Pediatric Associates; 🇺🇸 Mineola, New York, United States

Fomon Infant Nutrition Unit; 🇺🇸 Iowa City, Iowa, United States

Tampa Bay Medical Research; 🇺🇸 Clearwater, Florida, United States

Cary Pediatric Center; 🇺🇸 Cary, North Carolina, United States

Harvey Pediatrics; 🇺🇸 Jonesboro, Arkansas, United States

Pedia Research; 🇺🇸 Owensboro, Kentucky, United States

The Center for Human Nutrition; 🇺🇸 Omaha, Nebraska, United States

Children's Health Care; 🇺🇸 DeKalb, Illinois, United States

Boystown; 🇺🇸 Omaha, Nebraska, United States

Craig Spiegel, MD; 🇺🇸 Bridgeton, Missouri, United States

Lovelace Scientific Resources; 🇺🇸 Santa Ana, California, United States

Arklatex Children's Center; 🇺🇸 Bossier City, Louisiana, United States