Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

Phase 1

Terminated

• Conditions: Congenital Heart Disease; Hypoplastic Left Heart Syndrome
• Interventions: Drug: Curosurf; Drug: Sham

• Registration Number: NCT04181255
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-29
• Study Start: 2020-02-25
• Primary Completion: 2020-06-12
• Study Completion: 2020-06-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curosurf	Curosurf	-
Sham (air)	Sham	-

Primary Outcome Measures

Name	Time	Method
Number of days of mechanical ventilation	Throughout hospitalization (approximate average 5 days)	This will be the number of days from intubation to the extubation date.
Number of days in the Pediatric Cardiothoracic Unit	Approximately 11 days	From time of admission until transfer out of the unit.
Number of post-operative hospital days	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure	Up to 1 year	Post-surgery throughout hospitalization.
Total number of patients requiring thoracostomy tube placement for air leak not associated with standard post-operative management prior to extubation	Approximately 1 week	Post-surgery prior to extubation.
Changes in positive end-expiratory pressures post intervention	Baseline to approximately 1 week	After therapy until extubation.
Changes in peak inspiratory pressures post intervention	Baseline to approximately 1 week	After therapy until extubation.
Changes in dynamic lung compliance post intervention	Baseline to approximately 1 week	After therapy until extubation.
Changes in oxygen requirements post intervention	Baseline to approximately 1 week	After therapy until extubation.
Changes in oxygenation index (OI) post intervention	Baseline to approximately 1 week	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	Approximately 1 week	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.
Total number of patients requiring high frequency ventilation (HFV) (High frequency oscillator ventilation or High frequency jet ventilation)	Up to 1 year	Post-surgery throughout hospitalization.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States