NCT01310751

Study of Inhaled Iloprost in Pediatric Pulmonary Hypertension (PH) After Surgery

Randomized Double-blind Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension (PH) and Pulmonary Hypertensive Crisis (PHC) After Repair of Congenital Heart Disease (CHD)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 9 Days – 12 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine whether inhaled iloprost can be used to prevent and treat PH and PHC while in children after operation of CHD

Detailed description

Pulmonary hypertension (PH) is a significant contributor to the postoperative morbidity and mortality of congenital heart disease. Inhaled iloprost has been approved for the treatment of adults with PH, but little is known about the effects in children with PH. Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels without side affecting the systemic circulation. There is no RCTs of iloprost have previously been performed in this indication.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	iloprost nebuliser solusion	50 ng/kg/min inhalation for 10 minutes, q2h for 2 days
DRUG	distilled water	2 ml per session

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-03-08
• Last updated: 2015-11-24

Locations

1 site across 1 country: China