Clinical trial NCT04181255: Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy
Official title: The Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy Following Deep Hypothermic Circulatory Arrest During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Congenital Heart Disease
Hypoplastic Left Heart Syndrome
Keywords: Norwood procedure
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2019-11-29
Enrollment: 2
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

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.

Primary outcomes:
measure: Number of days of mechanical ventilation
timeFrame: Throughout hospitalization (approximate average 5 days)
measure: Number of days in the Pediatric Cardiothoracic Unit
timeFrame: Approximately 11 days
measure: Number of post-operative hospital days
timeFrame: Up to 1 year
Secondary outcomes:
measure: Total number of patients requiring thoracostomy tube placement for air leak not associated with standard post-operative management prior to extubation
timeFrame: Approximately 1 week
measure: Total number of patients requiring high frequency ventilation (HFV) (High frequency oscillator ventilation or High frequency jet ventilation)
timeFrame: Up to 1 year
measure: Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure
timeFrame: Up to 1 year
measure: Changes in positive end-expiratory pressures post intervention
timeFrame: Baseline to approximately 1 week
measure: Changes in peak inspiratory pressures post intervention
timeFrame: Baseline to approximately 1 week
measure: Changes in dynamic lung compliance post intervention
timeFrame: Baseline to approximately 1 week
measure: Changes in oxygen requirements post intervention
timeFrame: Baseline to approximately 1 week
measure: Changes in oxygenation index (OI) post intervention
timeFrame: Baseline to approximately 1 week
measure: Time to successful extubation readiness trials (ERT) post intervention
timeFrame: Approximately 1 week
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Steven Donn, MD
role: PRINCIPAL_INVESTIGATOR
References: