The Effects of Inhaled Nitric Oxide After Fontan Operation

April 26, 2023 updated by: Ellen Spurrier

The Effects of Inhaled Nitric Oxide on Patient Morbidity and Length of Hospital Stay Following Fontan Operation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • A. I. duPont Hospital for Children/Nemours Cardiac Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male/female patients
  • Undergoing Fontan operation at the Nemours Cardiac Center at A. I. duPont Hospital for Children
  • Written parental permission to participate in this research study

Exclusion Criteria:

  • Any condition which the PI feels will interfere with the patient's safe and effective participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Intervention/ historical control group
historical controls group of patients who did not receive iNO.
Experimental: Intervention
Prospective group who received iNO.
Drug: inhaled nitric oxide (iNO)
Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
Other Names:
  • Inomax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of Hospital Stay Following Fontan
Time Frame: until hospital discharge
until hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage
Time Frame: 2 weeks
Percent of patients with significant pleural fluid collections that required thoracostomy drainage
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ellen Spurrier

Collaborators

Mallinckrodt

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

July 23, 2009

First Posted (Estimate)

July 24, 2009

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPURE1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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