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Investigator Retirement
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| Name | Class |
|---|---|
| Chiesi Farmaceutici S.p.A. | INDUSTRY |
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This clinical trial is being done to see if giving surfactant (Curosurf®) will decrease the number of days that infants will need a breathing tube, decrease the days in the critical care unit and decrease the number of days needed in the hospital. The primary hypothesis for this study is that there will be fewer days needed on mechanical ventilation and improved lung compliance and pulmonary gas exchange.
This study will enroll infants undergoing cardiothoracic surgery requiring deep hypothermic circulatory arrest (DHCA) at the University of Michigan's C.S. Mott Children's Hospital. Patients that are eligible will be randomized to receive either one dose surfactant or the sham (air) arm after the surgical procedure. Patients will be monitored for an additional 30 days after the breathing tube is removed. It is possible that subjects may be discharged prior to the last assessment, therefore for subjects who have been discharged a member of the study team will contact the parent (s) or legal authorized representative by telephone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curosurf | Experimental |
| |
| Sham (air) | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curosurf | Drug | This arm will consist of a single dose of Curosurf (200 mg/kg) that will be given in the Pediatric Cardiothoracic Unit (PCTU) after surgery once the subject has reached a normalized body temperature. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days of mechanical ventilation | This will be the number of days from intubation to the extubation date. | Throughout hospitalization (approximate average 5 days) |
| Number of days in the Pediatric Cardiothoracic Unit | From time of admission until transfer out of the unit. | Approximately 11 days |
| Number of post-operative hospital days | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of patients requiring thoracostomy tube placement for air leak not associated with standard post-operative management prior to extubation | Post-surgery prior to extubation. | Approximately 1 week |
| Total number of patients requiring high frequency ventilation (HFV) (High frequency oscillator ventilation or High frequency jet ventilation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Donn, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018636 | Hypoplastic Left Heart Syndrome |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| C068291 | poractant alfa |
| D013501 | Surface-Active Agents |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| Sham | Drug | This arm will consist of a single dose of sham (air) that will be given through the endotracheal tube in the Pediatric Cardiothoracic Intensive Care Unit after surgery once the subject has reached a normalized body temperature. |
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Post-surgery throughout hospitalization. |
| Up to 1 year |
| Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure | Post-surgery throughout hospitalization. | Up to 1 year |
| Changes in positive end-expiratory pressures post intervention | After therapy until extubation. | Baseline to approximately 1 week |
| Changes in peak inspiratory pressures post intervention | After therapy until extubation. | Baseline to approximately 1 week |
| Changes in dynamic lung compliance post intervention | After therapy until extubation. | Baseline to approximately 1 week |
| Changes in oxygen requirements post intervention | After therapy until extubation. | Baseline to approximately 1 week |
| Changes in oxygenation index (OI) post intervention | OI is the product of mean airway pressure and fraction of inspired oxygen divided by the partial pressure of oxygen. After therapy until extubation. | Baseline to approximately 1 week |
| Time to successful extubation readiness trials (ERT) post intervention | Measured in hours until successful ERT, and then successful extubation. Not everyone who passes an ERT is immediately extubated (typically done once per day), so the plan is daily. Successful extubation is defined as remaining extubated for 48 hours. | Approximately 1 week |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |