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Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants

NCT00742534 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2011-12-30

No results posted yet for this study

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 purpose of this study is to determine the safety and optimal dose of intravenous L-citrulline in premature infants.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

DRUG

Intravenous L-Citrulline

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. This regimen will be adjusted with pharmacokinetic data as it becomes available so that it may be adjusted to maintain appropriate serum levels of the urea cycle precursors and NO metabolites of interest.

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Frederick E Barr, MD, MSCI · Vanderbilt University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00742534 on ClinicalTrials.gov