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

Withdrawn before enrolling · Phase 1

Conditions studied: Bronchopulmonary Dysplasia

In brief

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.

Key facts

Study ID

NCT00742534

Run by

Vanderbilt University

People needed

0

Starts

2008-08-01

Expected to finish

2009-08-01

Last updated by the study team

2011-12-30

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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.

Where it is running

• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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