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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00742534
• Date of registration: 25/08/2008
• Primary sponsor: Vanderbilt University
• Public title: Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants
• Scientific title: Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants
• Date of first enrolment: August 2008
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00742534
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Frederick E Barr, MD, MSCI
• Affiliation: Vanderbilt University

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 14 Days
Gender: Both

Health Condition(s) or Problem(s) studied

Bronchopulmonary Dysplasia

Intervention(s)

Drug: Intravenous L-Citrulline

Primary Outcome(s)

Pharmacokinetics and dose finding in preterm infants with BPD [Time Frame: Surrounding Dose]

Secondary ID(s)

BPD2008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors