Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy Following Deep Hypothermic Circulatory Arrest During Cardiac Surgery

Conditions
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Congenital Heart Disease, Hypoplastic Left Heart Syndrome

Intervention / Treatment
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* Drug: Curosurf
* Drug: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients less than or equal to 12 weeks of age with hypoplastic left heart syndrome (HLHS) undergoing cardiothoracic surgical correction (Norwood) requiring DHCA. Infants weighing 2500 grams or greater at the time of surgery. Written informed consent from parent(s) or legally appointed representative (LAR). Exclusion Criteria: Patients who are less than 36 weeks Post Menstrual Age (PMA) at the time of surgical correction. Underlying craniofacial, airway or lung anomalies which could compromise administration of surfactant. Infants weighing less than 2500 grams at the time of the surgical correction. Mechanical ventilation for> 7 days prior to surgical correction.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curosurf<br> | Drug: Curosurf<br>* 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.<br>* Other names: surfactant;|
| Placebo Comparator: Sham (air)<br> | Drug: Sham<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Norwood procedure