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

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Brief Title

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

Official Title

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

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

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 (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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Pharmacokinetics and dose finding in preterm infants with BPD

Condition

Bronchopulmonary Dysplasia

Intervention

Intravenous L-Citrulline

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

0

Start Date

August 2008

Completion Date

August 2009

Primary Completion Date

August 2009

Eligibility Criteria

        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.

Gender

All

Ages

N/A - 14 Days

Accepts Healthy Volunteers

No

Contacts

Frederick E Barr, MD, MSCI, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00742534

Organization ID

BPD2008

Study Sponsor

Vanderbilt University

Study Sponsor

Frederick E Barr, MD, MSCI, Principal Investigator, Vanderbilt University Medical Center

Verification Date

December 2011