Status:
WITHDRAWN
Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants
Lead Sponsor:
Vanderbilt University
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
2-14 years
Phase:
PHASE1
Brief Summary
Premature infants are at risk for developing bronchopulmonary dysplasia (BPD). L-citrulline may decrease that risk, but we do not know the safety or dose of this drug for use in premature babies. The ...
Detailed Description
This is a prospective phase I study of the safety, pharmacokinetics, and optimal dose of intravenously administered L-citrulline in premature infants born at 24 to 29 weeks estimated gestational age (...
Eligibility Criteria
Inclusion
- 24-29 Weeks Gestation
- Respiratory Distress requiring intubation and mechanical ventilation or positive pressure oxygen at 24 hours of life
- Parents willing and able to sign consent
Exclusion
- Congenital malformation
- Suspected genetic or metabolic syndrome
- Surgical condition
- Life expectancy \< 24 hours
- Pre-existing, sustained hypotension
- Birth weight \< 500 grams
- Any condition which, in the opinion of the investigator, will interfere with the study objectives.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00742534
Start Date
August 1 2008
End Date
August 1 2009
Last Update
December 30 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232