Growth of Infants Fed Hydrolysate Formulas
1 other identifier
interventional
195
1 country
8
Brief Summary
Effects on weight and weight gain will be monitored in healthy term infants fed assigned 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 Mar 2000
Shorter than P25 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2000
CompletedFirst Submitted
Initial submission to the registry
December 5, 2013
CompletedFirst Posted
Study publicly available on registry
December 10, 2013
CompletedDecember 12, 2013
December 1, 2013
8 months
December 5, 2013
December 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Weight
Study day 1 to 112 days of age
Secondary Outcomes (5)
Length
Study day 1 to 112 days of age
Head Circumference
Study day 1 to 112 days of age
Study Formula Intake
Enrollment to 112 days of age
Incidence of Spit Up
Enrollment to 112 days of age
Stool Pattern
Enrollment to 112 days of age
Study Arms (2)
RTF Infant Formula 1
ACTIVE COMPARATORa ready to feed (RTF) extensively hydrolyzed infant formula fed ad lib.
Powder Infant Formula 2
EXPERIMENTALa powdered extensively hydrolyzed infant formula fed ad lib.
Interventions
Eligibility Criteria
You may qualify if:
- Infants in good health.
- Singleton, term birth with a gestational age of 37 to 42 weeks.
- Birth weight of 2500 g (5 lb 8 oz) or greater.
- Between 0 and 9 days of age at enrollment.
- Not receiving vitamin or mineral supplements.
You may not qualify if:
- \- Maternal, fetal or perinatal medical history with potential for adverse effects on growth or development.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (8)
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Dreyer Medical Center
Aurora, Illinois, United States
PediaResearch, LLC
Evansville, Indiana, United States
The University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Kentucky Pediatric Research
Bardstown, Kentucky, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
NC Children's & Young Adults' Clinical Research Foundation
Chapel Hill, North Carolina, United States
GrandView Medical Research
Sellersville, Pennsylvania, United States
Study Officials
- STUDY CHAIR
Marlene Borschel, RD, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2013
First Posted
December 10, 2013
Study Start
March 1, 2000
Primary Completion
November 1, 2000
Study Completion
November 1, 2000
Last Updated
December 12, 2013
Record last verified: 2013-12