Pulmonary Hypertension Clinical Trial
Official title:
A Randomized, Double Blind, Placebo-controlled Pilot Study of the Safety and Effective Dosing of Inhaled Iloprost in Pediatric Patients With Pulmonary Hypertension Treated With Inhaled Nitric Oxide
Verified date | January 2015 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine whether inhaled iloprost is safe and effective in pediatric patients with pulmonary hypertension who are sick in the intensive care unit.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 21 Years |
Eligibility |
Inclusion Criteria: - Birth to 21 years of age - Diagnosis of pulmonary hypertension must fit into one of three categories - neonatal hypoxic respiratory failure - congenital heart disease - acquired/acute respiratory distress syndrome (lung disease) - Parents of subject must be able and willing to give written informed consent and comply with the requirements of the study protocol and must authorize release and use of protected health information - Patients who remain on nitric oxide at 12 to 18 hours after initiation - Patients who are transferred to an intensive care unit already on inhaled nitric oxide from another institution will be treated as if nitric oxide therapy was started at the time of admission to the unit - Patients will be enrolled only after a clinical decision to treat with nitric oxide has been made by the treating physician Exclusion Criteria: - Corrected gestational age less than 35 weeks - Patients with potentially fatal non-cardiopulmonary co-morbidities (e.g. hepatic, neurologic, renal) - Known or suspected fatal genetic syndrome - Patient with cardiac failure secondary to significant left-sided obstructive lesions - Patient on ECMO - Patient on any other form of prostacyclin - Patient on any medication with known NO production, e.g., nitroprusside - Patient on an endothelin receptor antagonist (e.g. bosentan) - Patient on sildenafil - Patient on whom clinicians do not agree to follow standard inhaled nitric oxide weaning protocol - Patients who have known hypersensitivity to prostacyclin or any of its components - Patient who is pregnant - Patient with platelet count less than 50,000 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital | Actelion |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the safety and effective dosing of inhaled iloprost in mechanically ventilated pediatric patients with pulmonary hypertension. | For the duration of time that the subject is receiving the study drug | Yes | |
Secondary | Time to wean off iNO. | When the participant is successfully weaned off study drug | No | |
Secondary | Time to extubation. | When the participant is successfully weaned off study drug | No | |
Secondary | Total cost of iNO. | When the participant is successfully weaned off study drug | No | |
Secondary | Incidence of rebound phenomenon, as defined by the need to return to a higher iNO dose after a previous wean. | When the participant is successfully weaned off study drug | No | |
Secondary | Time to ICU discharge | When the participant is successfully weaned off study drug. | No |
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Withdrawn |
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