Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants
| Status: | Archived |
|---|---|
| Conditions: | Bronchitis, Hematology |
| Therapuetic Areas: | Hematology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | August 2008 |
| End Date: | August 2009 |
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 purpose of this study is to determine the safety and optimal dose of
intravenous L-citrulline in premature infants.
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 (EGA) and who are at risk for bronchopulmonary dysplasia (BPD).
This is a classic dose escalation using initial doses of 10 mg/kg of intravenous citrulline
and advancing the dose by 10 mg/kg every 3 patients for a target peak plasma citrulline
concentration of 100 umol/L. These infants will undergo intense hemodynamic monitoring and
have intermittent blood sampling to determine levels of amino acids and nitric oxide
metabolites. From this, we will determine citrulline pharmacokinetics including half life,
clearance, and volume of distribution. Intravenous L-citrulline will be provided by
Asklepion Pharmaceuticals and mixed by the Investigational Drug Service of the Vanderbilt
Hospital Clinical Pharmacy. The study will be monitored closely by a data safety monitoring
board (DSMB) consisting of clinicians not involved with this study.
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