Phase 3 N=44 Treatment

The Effects of Inhaled Nitric Oxide After Fontan Operation

Congenital Heart Defect

Bottom Line

View on ClinicalTrials.gov: NCT00945529 ↗

Enrolled (actual)

Serious AEs

29.5%

Results posted

May 2023

Primary outcome: Primary: Length of Hospital Stay Following Fontan — 11.2; 11 days

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: inhaled nitric oxide (iNO) (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: Ellen Spurrier
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Length of Hospital Stay Following Fontan	11.2; 11	—
SECONDARY Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage	43.5; 33.4	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00945529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.