Growth Clinical Trial
Official title:
Growth and Tolerance of Cow's Milk-Based Infant Formulas
Verified date | March 2017 |
Source | Mead Johnson Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula.
Status | Completed |
Enrollment | 373 |
Est. completion date | December 15, 2016 |
Est. primary completion date | December 15, 2016 |
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 a minimum of 2500 grams - Solely formula fed - Signed Informed Consent and Protected Health Information Exclusion Criteria: - Anemia at time of birth - Current use of iron or iron-containing supplements - History of underlying metabolic or chronic disease or immunocompromised - Feeding difficulties or formula intolerance |
Country | Name | City | State |
---|---|---|---|
United States | Children's Research, LLC | Altamonte Springs | Florida |
United States | Heartland Research Associates, LLC | Augusta | Kansas |
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 | DCOL Center for Clinical Research | Longview | Texas |
United States | Heartland Research Associates, LLC | Newton | Kansas |
United States | Norwich Pediatric Group, P.C. | Norwich | Connecticut |
United States | Owensboro Pediatrics | Owensboro | Kentucky |
United States | Pediatrics East - Alabama Clinical Therapeutics | Pinson | Alabama |
United States | UHMP Comprehensive Pediatrics | Westlake | Ohio |
United States | Heartland Research Associates, LLC | Wichita | Kansas |
United States | Woburn Pediatic Associates | Woburn | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mead Johnson Nutrition |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body weight measured at each study visit | Measurement collected with a calibrated infant scale | 12 months | |
Secondary | Body length measured at each study visit | Measurement collected with a standardized length board | 12 months | |
Secondary | Head circumference measured at each study visit | Measurement collected with a standardized measuring tape | 12 months | |
Secondary | Parental recall of study formula intake at each study visit | 12 months | ||
Secondary | Parental recall of stool consistency measured at each study visit | 12 months | ||
Secondary | Blood Collection | Composite measure of hemoglobin, hematocrit, ferritin, and c-reactive protein | Once at 12 months | |
Secondary | Medically-confirmed adverse events collected throughout the study period | 12 months |
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