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

NCT00742534 | Withdrawn Phase 1 DMC

• 1 other identifier: BPD2008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary Dysplasia; Prematurity; Lung Disease; preterm infants

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics and dose finding in preterm infants with BPD

  Surrounding Dose

Interventions

Intravenous L-Citrulline DRUG

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.

Eligibility Criteria

• Age: 2 Days - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth; Lung Diseases

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Frederick E Barr, MD, MSCI

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 27, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 30, 2011

Record last verified: 2011-12

Locations

US (1)