Assessment of Growth of Infants Fed a New Formula
1 other identifier
interventional
180
1 country
3
Brief Summary
The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
3 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
July 9, 2009
CompletedFirst Posted
Study publicly available on registry
July 10, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 26, 2013
June 1, 2013
3.3 years
July 9, 2009
June 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean weight gain
4 months
Secondary Outcomes (1)
anthropometry, tolerance, morbidity, blood tests
9 months
Study Arms (2)
Standard infant formula
ACTIVE COMPARATORTest formula
EXPERIMENTALInterventions
Standard infant formula given during the first 9 months of life, as per standard requirement
Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.
Eligibility Criteria
You may qualify if:
- Healthy newborn infant
- Full-term (\>37 weeks gestation)
- Birth weight between \> 2500 and \< 4500 g
- Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment
- Tolerating a cows milk based formula for at least 3 days
- Study explained and written information provided with Parent/Caregiver demonstrating understanding of the given information
- Informed consent signed (Parent/Legal representative)
- Parent/Caregiver has a working freezer
- Lives within 45 minutes of a study site
You may not qualify if:
- Congenital illness or malformation that may affect infant feeding and/or normal 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 intravenous antibiotic therapy in the 10 days prior to enrollment
- Infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
- 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 (3)
Pedia Research, LLC
Newburgh, Indiana, 47630, United States
Pedia Research, LLC
Owensboro, Kentucky, 42301, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Feigelman, MD
University of Maryland School of Medicine, Department of Pediatrics
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
July 9, 2009
First Posted
July 10, 2009
Study Start
February 1, 2010
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
June 26, 2013
Record last verified: 2013-06