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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2
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.
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.
University of Michigan
Ann Arbor, Michigan, United States
Number of days of mechanical ventilation
This will be the number of days from intubation to the extubation date.
Time frame: Throughout hospitalization (approximate average 5 days)
Number of days in the Pediatric Cardiothoracic Unit
From time of admission until transfer out of the unit.
Time frame: Approximately 11 days
Number of post-operative hospital days
Time frame: Up to 1 year
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.
Time frame: 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.
Time frame: Up to 1 year
Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure
Post-surgery throughout hospitalization.
Time frame: Up to 1 year
Changes in positive end-expiratory pressures post intervention
After therapy until extubation.
Time frame: Baseline to approximately 1 week
Changes in peak inspiratory pressures post intervention
After therapy until extubation.
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Time frame: Baseline to approximately 1 week
Changes in dynamic lung compliance post intervention
After therapy until extubation.
Time frame: Baseline to approximately 1 week
Changes in oxygen requirements post intervention
After therapy until extubation.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 1 week