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Completed

NCT Number: NCT00945529

The Effects of Inhaled Nitric Oxide After 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.

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Key information

Conditions

Congenital Heart Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

A. I. duPont Hospital for Children/Nemours Cardiac Center

Wilmington, Delaware, 19803, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled Nitric Oxide (iNO)

Drug

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

Other names: Inomax

Primary outcomes

  1. Length of Hospital Stay Following Fontan

    Time frame: until hospital discharge

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ellen Spurrier

Other

Collaborators

  • Mallinckrodt

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 24, 2009
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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