Clinical trial NCT00666120: Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
Official title: Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Term Infants Solely Formula Fed
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 333
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator
timeFrame: 60 days
Secondary outcomes:
measure: Infant temperament
timeFrame: 60 days
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Harvey Pediatrics
state: Arkansas
city: Rogers
country: United States
facility: Mercy Rogers Pediatric Clinic
state: Arkansas
city: Santa Ana
country: United States
facility: Lovelace Scientific Resources
state: California
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Tamarac
country: United States
facility: Children's Medical Association
state: Florida
city: DeKalb
country: United States
facility: Children's Health Care
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Iowa City
country: United States
facility: Fomon Infant Nutrition Unit
state: Iowa
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Louisville
country: United States
facility: Pediatrics Clinical Trials Unit
state: Kentucky
city: Owensboro
country: United States
facility: Pedia Research
state: Kentucky
city: Bossier City
country: United States
facility: Arklatex Children's Center
state: Louisiana
city: Bridgeton
country: United States
facility: Craig Spiegel, MD
state: Missouri
city: Omaha
country: United States
facility: The Center for Human Nutrition
state: Nebraska
city: Omaha
country: United States
facility: Boystown
state: Nebraska
city: Mineola
country: United States
facility: Winthrop Pediatric Associates
state: New York
city: Cary
country: United States
facility: Cary Pediatric Center
state: North Carolina
city: Texarkana
country: United States
facility: Collom and Carney Clinic
state: Texas
Study officials:
affiliation: Mead Johnson Nutrition
name: Carol Berseth, MD
role: STUDY_DIRECTOR
References:
citation: Berseth CL, Mitmesser SH, Ziegler EE, Marunycz JD, Vanderhoof J. Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants. Nutr J. 2009 Jun 19;8:27. doi: 10.1186/1475-2891-8-27.