Status:
COMPLETED
Nutritional Study in Preterm Infants
Lead Sponsor:
Abbott Nutrition
Conditions:
Preterm Infants
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE3
Brief Summary
An evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk
Eligibility Criteria
Inclusion
- Birthweight 500-1800 g
- Less than 33 wks gestational age
- Enteral feeding initiated by 21 days of life
- Asymmetrical small-for-gestational age (SGA) infants and infants with patent ductus arteriosus (PDA) are eligible to participate
- Singleton or twin births only
- Infant is 21 days of age or less at time of randomization
Exclusion
- Serious congenital abnormalities that may affect growth and development
- Grade III or IV intraventricular hemorrhage (IVH)
- Maternal incapacity
- History of major surgery
- Extracorporeal membrane oxygenation (ECMO)
- Asphyxia
- Confirmed NEC or positive blood cultures at the time of randomization
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00707837
Start Date
May 1 2005
End Date
August 1 2008
Last Update
April 27 2009
Active Locations (8)
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1
University of Alabama
Birmingham, Alabama, United States, 35233
2
West Coast Neonatalogy, All Children's Hospital
St. Petersburg, Florida, United States, 33701
3
University of South Florida
Tampa, Florida, United States, 33606
4
University of Louisville
Louisville, Kentucky, United States, 40202