Growth and Tolerance of Infants Fed Formula for 16 Weeks
Growth Monitoring Study of Infants Fed Formula for 16 Weeks
1 other identifier
interventional
216
1 country
24
Brief Summary
Growth and Tolerance Trial of Iron-fortified infant formulas
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Typical duration for not_applicable
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
March 27, 2018
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedStudy Start
First participant enrolled
July 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2020
CompletedJuly 10, 2020
July 1, 2020
2 years
March 27, 2018
July 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Growth
Weight Gain
16 weeks
Study Arms (2)
Growth, Tolerance of Infants-Exp
ACTIVE COMPARATORInfant Formula
Growth,Tolerance of Infants-Com
ACTIVE COMPARATORInfant Formula
Interventions
Multi-centered, prospective, randomized clinical trial
Eligibility Criteria
You may qualify if:
- Healthy term infants, 37-42 weeks gestational age
You may not qualify if:
- Any condition that would negatively impact assessment of growth and tolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nature's Onelead
Study Sites (24)
Visions Clinical Research-Tucson
Tucson, Arizona, 85712, United States
Harris Pediatric Clinic
Newport, Arkansas, 72112, United States
Searcy Medical Center
Searcy, Arkansas, 72143, United States
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360, United States
Pediatrics by the Sea
Delray Beach, Florida, 33483, United States
Altamonte Pediatric Associates
Lake Mary, Florida, 32746, United States
New Horizon Research Center
Miami, Florida, 33175, United States
Paramount Research Solutions
College Park, Georgia, 30349, United States
Qualmedica Research
Evansville, Indiana, 47715, United States
Qualmedica Research
Owensboro, Kentucky, 43201, United States
Portico Pediatrics
Shreveport, Louisiana, 71105, United States
Gvozden Pediatrics
Millersville, Maryland, 21108, United States
Valley Stream Pediatrics_Lashley
Valley Stream, New York, 11580, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28304, United States
Pediatric Partners
Raleigh, North Carolina, 27609, United States
Piedmont Healthcare
Statesville, North Carolina, 28625, United States
Aventiv Research, Inc
Columbus, Ohio, 43123, United States
Ohio Pediatric Research Association
Dayton, Ohio, 45414, United States
Cynthia Strieter-Boland, MD
Westlake, Ohio, 44145, United States
Red Lion Pediatrics
Bensalem, Pennsylvania, 19020, United States
Coastal Pediatric Associates
Charleston, South Carolina, 29414, United States
Coastal Pediatric Research
North Charleston, South Carolina, 29406, United States
Southwestern Children's Research Associates, PA
San Antonio, Texas, 78229, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert D Murray, MD
Consultant
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Eligible infants are randomized to commercial control or experimental product.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2018
First Posted
April 3, 2018
Study Start
July 18, 2018
Primary Completion
July 9, 2020
Study Completion
July 9, 2020
Last Updated
July 10, 2020
Record last verified: 2020-07