Congenital Heart Defect
Conditions
Keywords
Fontan
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.
Interventions
Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
Sponsors
Mallinckrodt
Ellen Spurrier
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of Hospital Stay Following Fontan | until hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage | 2 weeks | Percent of patients with significant pleural fluid collections that required thoracostomy drainage |
Countries
United States
Participant flow
Recruitment details
Prospective participant recruitment took place between February 2008 and December 2010 at the Nemours Cardiac Center at A. I. duPont hospital for Children.
Participants by arm
| Arm | Count |
|---|---|
| No Intervention/ Historical Control Group historical controls group of patients who did not receive iNO / data collected under waiver of consent | 23 |
| Intervention Prospective group who received iNO / Consent obtained
inhaled nitric oxide: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean. | 21 |
| Total | 44 |
Baseline characteristics
| Characteristic | No Intervention/ Historical Control Group | Intervention | Total |
|---|---|---|---|
| Age, Continuous | 18.5 months | 21.0 months | 19.7 months |
| Region of Enrollment United States | 23 participants | 21 participants | 44 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Male | 18 Participants | 13 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 23 | 6 / 21 |
| serious Total, serious adverse events | 8 / 23 | 5 / 21 |
Outcome results
Primary
Length of Hospital Stay Following Fontan
Time frame: until hospital discharge
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Intervention/ Historical Control Group | Length of Hospital Stay Following Fontan | 11.2 days |
| Intervention | Length of Hospital Stay Following Fontan | 11 days |
Secondary
Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage
Percent of patients with significant pleural fluid collections that required thoracostomy drainage
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Intervention/ Historical Control Group | Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage | 43.5 percentage |
| Intervention | Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage | 33.4 percentage |