The Effects of Inhaled Nitric Oxide After Fontan Operation
1 other identifier
interventional
21
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
July 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
May 19, 2023
CompletedMay 19, 2023
April 1, 2023
3.8 years
May 28, 2009
August 24, 2021
April 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of Hospital Stay Following Fontan
until hospital discharge
Secondary Outcomes (1)
Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage
2 weeks
Study Arms (2)
No Intervention/ historical control group
NO INTERVENTIONhistorical controls group of patients who did not receive iNO.
Intervention
EXPERIMENTALProspective group who received iNO.
Interventions
Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any condition which the PI feels will interfere with the patient's safe and effective participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ellen Spurrierlead
- Mallinckrodtcollaborator
Study Sites (1)
A. I. duPont Hospital for Children/Nemours Cardiac Center
Wilmington, Delaware, 19803, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ellen Spurrier, MD
- Organization
- Nemours Cardiac Center at A. I. duPont Hospital for Children
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen Spurrier, MD
Nemours Children's Clinic - A. I. duPont Hospital for Children
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Cardiac Anesthesiology
Study Record Dates
First Submitted
May 28, 2009
First Posted
July 24, 2009
Study Start
February 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
May 19, 2023
Results First Posted
May 19, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share