Back to resultsCold Heart Study: A Randomized Pilot Trial of Surfactant Therapy
Primary Purpose
Congenital Heart Disease, Hypoplastic Left Heart Syndrome
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Curosurf
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease focused on measuring Norwood procedure
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.
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Curosurf
Sham (air)
Arm Description
Outcomes
Primary Outcome Measures
Number of days of mechanical ventilation
This will be the number of days from intubation to the extubation date.
Number of days in the Pediatric Cardiothoracic Unit
From time of admission until transfer out of the unit.
Number of post-operative hospital days
Secondary Outcome Measures
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.
Total number of patients requiring high frequency ventilation (HFV) (High frequency oscillator ventilation or High frequency jet ventilation)
Post-surgery throughout hospitalization.
Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure
Post-surgery throughout hospitalization.
Changes in positive end-expiratory pressures post intervention
After therapy until extubation.
Changes in peak inspiratory pressures post intervention
After therapy until extubation.
Changes in dynamic lung compliance post intervention
After therapy until extubation.
Changes in oxygen requirements post intervention
After therapy until extubation.
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 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.
Full Information
NCT ID
NCT04181255
First Posted
November 26, 2019
Last Updated
September 7, 2023
Sponsor
University of Michigan
Collaborators
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT04181255
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Investigator Retirement
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
June 12, 2020 (Actual)
Study Completion Date
June 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Chiesi Farmaceutici S.p.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Hypoplastic Left Heart Syndrome
Keywords
Norwood procedure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curosurf
Arm Type
Experimental
Arm Title
Sham (air)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Curosurf
Other Intervention Name(s)
poractant alfa, surfactant
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of days of mechanical ventilation
Description
This will be the number of days from intubation to the extubation date.
Time Frame
Throughout hospitalization (approximate average 5 days)
Title
Number of days in the Pediatric Cardiothoracic Unit
Description
From time of admission until transfer out of the unit.
Time Frame
Approximately 11 days
Title
Number of post-operative hospital days
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Total number of patients requiring thoracostomy tube placement for air leak not associated with standard post-operative management prior to extubation
Description
Post-surgery prior to extubation.
Time Frame
Approximately 1 week
Title
Total number of patients requiring high frequency ventilation (HFV) (High frequency oscillator ventilation or High frequency jet ventilation)
Description
Post-surgery throughout hospitalization.
Time Frame
Up to 1 year
Title
Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure
Description
Post-surgery throughout hospitalization.
Time Frame
Up to 1 year
Title
Changes in positive end-expiratory pressures post intervention
Description
After therapy until extubation.
Time Frame
Baseline to approximately 1 week
Title
Changes in peak inspiratory pressures post intervention
Description
After therapy until extubation.
Time Frame
Baseline to approximately 1 week
Title
Changes in dynamic lung compliance post intervention
Description
After therapy until extubation.
Time Frame
Baseline to approximately 1 week
Title
Changes in oxygen requirements post intervention
Description
After therapy until extubation.
Time Frame
Baseline to approximately 1 week
Title
Changes in oxygenation index (OI) post intervention
Description
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
Title
Time to successful extubation readiness trials (ERT) post intervention
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Donn, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy
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