Bronchopulmonary Dysplasia Clinical Trial
Official title:
Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants
Verified date | December 2011 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 14 Days |
Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetics and dose finding in preterm infants with BPD | Surrounding Dose | Yes |
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