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The Effects of Inhaled Nitric Oxide After Fontan Operation

E

Ellen Spurrier

Status and phase

Completed
Phase 3
Phase 2

Conditions

Congenital Heart Defect

Treatments

Drug: inhaled nitric oxide (iNO)

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

1 to 5 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 2 patient groups

No Intervention/ historical control group
No Intervention group
Description:
historical controls group of patients who did not receive iNO.
Intervention
Experimental group
Description:
Prospective group who received iNO.
Treatment:
Drug: inhaled nitric oxide (iNO)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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