Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04181255
• Other study ID #: HUM00160492
• Status: Terminated
• Phase: Phase 1
• Start date: February 25, 2020
• Est. completion date: June 12, 2020

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 12 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Hypoplastic Left Heart Syndrome

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Number of days in the Pediatric Cardiothoracic Unit	From time of admission until transfer out of the unit.	Approximately 11 days
Primary	Number of post-operative hospital days		Up to 1 year
Secondary	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
Secondary	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
Secondary	Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure	Post-surgery throughout hospitalization.	Up to 1 year
Secondary	Changes in positive end-expiratory pressures post intervention	After therapy until extubation.	Baseline to approximately 1 week
Secondary	Changes in peak inspiratory pressures post intervention	After therapy until extubation.	Baseline to approximately 1 week
Secondary	Changes in dynamic lung compliance post intervention	After therapy until extubation.	Baseline to approximately 1 week
Secondary	Changes in oxygen requirements post intervention	After therapy until extubation.	Baseline to approximately 1 week
Secondary	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
Secondary	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