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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bronchopulmonary Dysplasia

Keywords

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Bronchopulmonary Dysplasia Prematurity Lung Disease preterm infants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

2 Days

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Vanderbilt University Medical Center

Principal Investigators

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Frederick E Barr, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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BPD2008

Identifier Type: -

Identifier Source: org_study_id