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Clinical trial

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

ID
Name
HUM00160492
Description
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.
Trial arms
Trial start
2020-02-25
Estimated PCD
2020-06-12
Trial end
2020-06-12
Status
Terminated
Phase
Early phase I
Treatment
Curosurf
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.
Arms:
Curosurf
Other names:
poractant alfa, surfactant
Sham
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.
Arms:
Sham (air)
Size
2
Primary endpoint
Number of days of mechanical ventilation
Throughout hospitalization (approximate average 5 days)
Number of days in the Pediatric Cardiothoracic Unit
Approximately 11 days
Number of post-operative hospital days
Up to 1 year
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 2, 'type': 'ACTUAL'}}
Updated at
2023-09-13

1 organization

2 products

2 indications

Organization
University of Michigan
Product
Curosurf
Indication
Congenital Heart Disease
Indication
Hypoplastic Left Heart Syndrome
Product
Sham