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Growth and Tolerance of a Partially Hydrolyzed Infant Formula

CompletedNA

Sponsor: Mead Johnson Nutrition

Conditions: Growth

Interventions: Cow's milk protein infant formula, Partially hydrolyzed protein infant formula

Countries: United States

The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.

Eligibility overview

Sex: ALL

Age: 10 Days to 14 Days

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 10 to 14 days of age at randomization
* singleton birth
* Gestational age of 37 to 42 weeks
* Birth weight of 2500 g (5lbs 8oz or more)
* Exclusively receiving infant formula for at least 24 hours prior to randomization
* Parent or legal guardian has full intention to exclusively feed study formula through 120 days of age
* Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
* Signed informed consent and authorization to use and disclose Protected Health information

Exclusion Criteria:

* History of underlying metabolic or chronic disease
* Evidence of feeding difficulties or history of formula intolerance
* Weight at Visit 1 is \<98% of birth weight
* Infant was born large for gestational age from a mother who was diabetic at childbirth
* Infant is immunocompromised

Locations (13)

Birmingham, Alabama, United States
Dothan, Alabama, United States
Tucson, Arizona, United States
Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Tampa, Florida, United States
Union City, Georgia, United States
Nampa, Idaho, United States
Owensboro, Kentucky, United States
Grand Island, Nebraska, United States
Jackson, Tennessee, United States
Longview, Texas, United States
McAllen, Texas, United States