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The Effects of Inhaled Nitric Oxide After Fontan Operation

NCT00945529 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-05-19

Study results available
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Summary

Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after Fontan operation will improve fluid balance, thus decreasing the incidence of pleural effusions and shortening hospital stay.

Conditions

  • Congenital Heart Defect

Interventions

DRUG

inhaled nitric oxide (iNO)

Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • Ellen Spurrier

    lead OTHER

Principal Investigators

  • Ellen Spurrier, MD · Nemours Children's Clinic - A. I. duPont Hospital for Children

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00945529 on ClinicalTrials.gov