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Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)

NCT01598441 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-11-22

No results posted yet for this study

Summary

This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

iloprost nebuliser solution

Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days

DRUG

distilled water

1-2 ml aerosolized distilled water inhalation per session

Sponsors & Collaborators

  • Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery

    collaborator UNKNOWN

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Zhuomin Xu, PhD · Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01598441 on ClinicalTrials.gov