Clinical trial NCT01122654: Growth and Tolerance of Cow Milk-Based Infant Formulas
Official title: Growth and Tolerance of Cow Milk-Based Infant Formulas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Weight
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 405
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy, term infants

Brief summary: This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.


Eligibility criteria: Inclusion Criteria:

* Singleton, 12-16 days of age at randomization
* Term infant with birth weight of minimum of 2500 g
* Solely formula fed
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* History of underlying metabolic or chronic disease or immunocompromised
* Acute infection
* Feeding difficulties or formula intolerance

Primary outcomes:
measure: Body weight measured on calibrated infant scale at each study visit
Secondary outcomes:
measure: Twenty-four hour recall of infant formula intake at each study visit
measure: Medically-confirmed adverse events collected throughout the study period
measure: Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit
measure: Parental Product Assessment Questionnaire completed at Study Visit 2
measure: Body Length and Head Circumference measured at each study visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Pinson
country: United States
facility: Pediatrics East - Alabama Clinical Therapeutics
state: Alabama
city: Benton
country: United States
facility: Central Arkansas Pediatric Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Norwich
country: United States
facility: Norwich Pediatric Group, PC
state: Connecticut
city: Lake Mary
country: United States
facility: Altamonte Pediatric Associates
state: Florida
city: Plantation
country: United States
facility: Children's Medical Association
state: Florida
city: Dalton
country: United States
facility: North Georgia Clinical Research Center/White's Pediatrics
state: Georgia
city: Newburgh
country: United States
facility: Deaconess Clinic Gateway
state: Indiana
city: Louisville
country: United States
facility: PTCU/Children & Youth Project
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Pediatrics
state: Kentucky
city: Woburn
country: United States
facility: Woburn Pediatric Associates
state: Massachusetts
city: Niles
country: United States
facility: Southwestern Medical Clinic, PC
state: Michigan
city: Stevensville
country: United States
facility: Southwestern Medical Clinic P.C.
state: Michigan
city: Omaha
country: United States
facility: The Center for Human Nutrition
state: Nebraska
city: Cary
country: United States
facility: Cary Pediatric Center, PA
state: North Carolina
city: Fargo
country: United States
facility: Innovis Health South University
state: North Dakota
city: Philadelphia
country: United States
facility: Red Lion Pediatrics
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Primary Physicians Research, Inc
state: Pennsylvania
city: Clarksville
country: United States
facility: Alpha Clinical Research
state: Tennessee
city: Jackson
country: United States
facility: The Jackson Clinic - North Jackson
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Austin
country: United States
facility: Austin Diagnostic Clinic
state: Texas
Study officials:
References:
citation: Johnston WH, Ashley C, Yeiser M, Harris CL, Stolz SI, Wampler JL, Wittke A, Cooper TR. Growth and tolerance of formula with lactoferrin in infants through one year of age: double-blind, randomized, controlled trial. BMC Pediatr. 2015 Nov 7;15:173. doi: 10.1186/s12887-015-0488-3.