Growth of Infants Fed an Extensively Hydrolyzed Infant Formula
Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.
1 other identifier
interventional
282
1 country
20
Brief Summary
The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2010
Typical duration for not_applicable
20 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
First Submitted
Initial submission to the registry
September 27, 2010
CompletedFirst Posted
Study publicly available on registry
September 28, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJune 26, 2014
June 1, 2014
2.7 years
September 27, 2010
June 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Weight Gain
Mean weight gain (g/day) from enrollment to 4 months of age.
4 Months
Study Arms (2)
New hydrolyzed infant formula
EXPERIMENTALNew, extensively hydrolyzed infant formula
Commercially available infant formula
ACTIVE COMPARATORCommercially available, extensively hydrolyzed infant formula.
Interventions
New hydrolyzed infant formula.
Commercially available infant formula.
Eligibility Criteria
You may qualify if:
- Healthy newborn singleton infant
- Full-term (\>= 37 weeks gestation)
- Birth weight between \>= 2500 and \< =4500 g
- ± 3 days of age on enrollment
- Infant's mother has elected not to breastfeed
- baby has been exclusively formula fed a minimum of 3 days prior to enrollment
- Study explained and written information provided with Parent/Caregiver
- Informed consent signed (parent/legal representative)
You may not qualify if:
- Congenital illness or malformation affecting infant feeding and/or growth
- Suspected or known allergy to cow's milk protein
- Significant pre-natal and/or post-natal disease
- Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
- Infant has received oral or IV antibiotic therapy in the 10 days prior to enrollment
- Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
- Infant has received probiotics in the seven days prior to enrollment
- Infant currently participating in another clinical study
- Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Colorado Springs Health Partners
Colorado Springs, Colorado, United States
Pedia Research
Newburgh, Indiana, 42301, United States
Pedia Research
Owensboro, Kentucky, 42301, United States
ARK-LA-Tex Pediatric Research
Bossier City, Louisiana, United States
The Clinical Trials Center
New Orleans, Louisiana, 70118, United States
Clinical Research of Nevada
Las Vegas, Nevada, United States
Institute of Clinical Research
Mayfield Heights, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cyn3rgy Research
Gresham, Oregon, United States
Square-1 Clinical Research
Erie, Pennsylvania, United States
Alpha Clinical Research
Clarksville, Tennessee, United States
Jackson Clinic
Jackson, Tennessee, 38305, United States
Scott & White Wells Branch Clinic
Austin, Texas, 78728, United States
Scott & White Killeen Clinic
Killeen, Texas, 76543, United States
DCOL Center for Research
Longview, Texas, United States
Southwest Children's Research Associates
San Antonio, Texas, 78229, United States
Scott & White Temple
Temple, Texas, 76508, United States
Tanner Clinic
Layton, Utah, United States
Clinical Research Partners
Richmond, Virginia, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo Sorensen, MD
Louisiana State University Health Sciences Center in New Orleans
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2010
First Posted
September 28, 2010
Study Start
November 1, 2010
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
June 26, 2014
Record last verified: 2014-06