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

• Status: Withdrawn
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center

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.