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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention/ historical control group | No Intervention | historical controls group of patients who did not receive iNO. | |
| Intervention | Experimental | Prospective group who received iNO. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhaled nitric oxide (iNO) | Drug | Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay Following Fontan | until hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage | Percent of patients with significant pleural fluid collections that required thoracostomy drainage | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Spurrier, MD | Nemours Children's Clinic - A. I. duPont Hospital for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A. I. duPont Hospital for Children/Nemours Cardiac Center | Wilmington | Delaware | 19803 | United States |
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Prospective participant recruitment took place between February 2008 and December 2010 at the Nemours Cardiac Center at A. I. duPont hospital for Children.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Intervention/ Historical Control Group | historical controls group of patients who did not receive iNO. |
| FG001 | Intervention | Prospective group who received iNO. inhaled nitric oxide: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Prospective intervention group - consent obtained prior to research activity Historical control group - data collection only - waiver of consent
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| ID | Title | Description |
|---|---|---|
| BG000 | No Intervention/ Historical Control Group | historical controls group of patients who did not receive iNO / data collected under waiver of consent |
| BG001 | Intervention | Prospective group who received iNO / Consent obtained inhaled nitric oxide: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Hospital Stay Following Fontan | Posted | Mean | Full Range | days | until hospital discharge |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Intervention/ Historical Control Group | Historical controls group of patients who did not receive iNO. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| prolonged hospital stay due to infection | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleural effusion requiring drainage | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Spurrier, MD | Nemours Cardiac Center at A. I. duPont Hospital for Children | 302-651-6600 | ellen.spurrier@nemours.org |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D045462 | Endothelium-Dependent Relaxing Factors |
| ID | Term |
|---|---|
| D014665 | Vasodilator Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
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| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Posted | Number | percentage | 2 weeks |
|
|
|
| 8 |
| 23 |
| 7 |
| 23 |
| EG001 | Intervention | Prospective group who received iNO. inhaled nitric oxide: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean. | 5 | 21 | 6 | 21 |
| Prolonged hospital stay due to feeding issue | Metabolism and nutrition disorders | feeding intolerance with hyponatremia |
|
| Prolonged hospital stay due to atelectasis | Respiratory, thoracic and mediastinal disorders |
|
| Prolonged hospital stay due to pleural effusion | Respiratory, thoracic and mediastinal disorders |
|
| Prolonged hospital stay due to seizures | Nervous system disorders |
|
| Prolonged hospital stay due to SVT | Cardiac disorders |
|
| Reoperation | Surgical and medical procedures | Superior Vena Cava (SVC) stenosis and large lateral tunnel fenestration after Fontan which required reoperation. |
|
| Prolonged hospital stay due to sepsis | Infections and infestations |
|
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020164 |
| Chemical Actions and Uses |