Growth and Tolerance of Cow Milk-Based Infant Formulas
1 other identifier
observational
405
1 country
24
Brief Summary
This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2010
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2010
CompletedFirst Posted
Study publicly available on registry
May 13, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 31, 2012
January 1, 2012
1.4 years
May 10, 2010
January 27, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Body weight measured on calibrated infant scale at each study visit
Secondary Outcomes (5)
Twenty-four hour recall of infant formula intake at each study visit
Medically-confirmed adverse events collected throughout the study period
Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit
Parental Product Assessment Questionnaire completed at Study Visit 2
Body Length and Head Circumference measured at each study visit
Study Arms (3)
Control
Experimental 1
Experimental 2
Eligibility Criteria
Healthy, term infants
You may qualify if:
- 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
You may not qualify if:
- History of underlying metabolic or chronic disease or immunocompromised
- Acute infection
- Feeding difficulties or formula intolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Birmingham Pediatric Associates
Birmingham, Alabama, 35205, United States
Southeastern Pediatric Associates
Dothan, Alabama, 36305, United States
Pediatrics East - Alabama Clinical Therapeutics
Pinson, Alabama, 35126, United States
Central Arkansas Pediatric Clinic
Benton, Arkansas, 72019, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205, United States
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360, United States
Altamonte Pediatric Associates
Lake Mary, Florida, 32746, United States
Children's Medical Association
Plantation, Florida, 33324, United States
North Georgia Clinical Research Center/White's Pediatrics
Dalton, Georgia, 30721, United States
Deaconess Clinic Gateway
Newburgh, Indiana, 47630, United States
PTCU/Children & Youth Project
Louisville, Kentucky, 40202, United States
Owensboro Pediatrics
Owensboro, Kentucky, 42303, United States
Woburn Pediatric Associates
Woburn, Massachusetts, 01801, United States
Southwestern Medical Clinic, PC
Niles, Michigan, 49120, United States
Southwestern Medical Clinic P.C.
Stevensville, Michigan, 49127, United States
The Center for Human Nutrition
Omaha, Nebraska, 68105, United States
Cary Pediatric Center, PA
Cary, North Carolina, 27511, United States
Innovis Health South University
Fargo, North Dakota, 58103, United States
Red Lion Pediatrics
Philadelphia, Pennsylvania, 19114, United States
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, 15241, United States
Alpha Clinical Research
Clarksville, Tennessee, 37043, United States
The Jackson Clinic - North Jackson
Jackson, Tennessee, 38305, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Austin Diagnostic Clinic
Austin, Texas, 78745, United States
Related Publications (1)
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.
PMID: 26547414DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 10, 2010
First Posted
May 13, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
January 31, 2012
Record last verified: 2012-01