A Phase 1/2 interventional study of Iloprost and Placebo in Pulmonary Hypertension, Neonatal Hypoxic Respiratory Failure and Persistent Pulmonary Hypertension of Newborn, sponsored by Seattle Children's Hospital. Withdrawn. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2015-01-19.
Sponsored by Seattle Children's Hospital · Phase 1/2, Interventional, and Treatment
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.
Inhaled nitric oxide (NO) is used in the management of all causes of pediatric pulmonary hypertension. Despite widespread use of nitric oxide to treat critically ill mechanically-ventilated pediatric patients with pulmonary hypertension, response to therapy is not universal. Nitric oxide fails to improve oxygenation in approximately 30% of these patients. Nonresponders to nitric oxide have few treatment options. Iloprost is the only other medication approved for inhalational delivery in the treatment of pulmonary hypertension. Inhalation therapy for pulmonary vasodilatation in critically ill children is inherently more attractive than oral or intravenous therapies due to the ability to deliver medication directly to the lung and to decrease systemic effects. The use of inhaled iloprost has been reported to decrease pulmonary vascular resistance in many pediatric pathologic settings, including combination therapy with nitric oxide.
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Diagnosis of pulmonary hypertension must fit into one of three categories
Exclusion Criteria:
Drug: Iloprost
Drug: Placebo
Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours; uptitrated to effect, to maximum dose of 30 mcg every 30 minutes
Also known as: Ventavis
Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more
To determine the safety and effective dosing of inhaled iloprost in mechanically ventilated pediatric patients with pulmonary hypertension.
Time frame: For the duration of time that the subject is receiving the study drug
Time to wean off iNO.
Time frame: When the participant is successfully weaned off study drug
Time to extubation.
Time frame: When the participant is successfully weaned off study drug
Total cost of iNO.
Time frame: When the participant is successfully weaned off study drug
Incidence of rebound phenomenon, as defined by the need to return to a higher iNO dose after a previous wean.
Time frame: When the participant is successfully weaned off study drug
Time to ICU discharge
Time frame: When the participant is successfully weaned off study drug.
No study locations are listed for this record.
This study is withdrawn, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Seattle Children's Hospital