Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

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

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.

Study Overview

• Status: Terminated
• Conditions: Congenital Heart Disease; Hypoplastic Left Heart Syndrome
• Intervention / Treatment: Drug: Curosurf; Drug: Sham

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bre'Anna Simpson; Phone Number: 734-615-4630; Email: sbreanna@umich.edu
• Study Contact Backup: Name: Steven Donn, MD; Phone Number: 734-232-0334; Email: smdonnmd@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 months (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curosurf	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.; Other Names: poractant alfa; surfactant
Placebo Comparator: Sham (air)	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Number of days in the Pediatric Cardiothoracic Unit	From time of admission until transfer out of the unit.	Approximately 11 days
Number of post-operative hospital days		Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure	Post-surgery throughout hospitalization.	Up to 1 year
Changes in positive end-expiratory pressures post intervention	After therapy until extubation.	Baseline to approximately 1 week
Changes in peak inspiratory pressures post intervention	After therapy until extubation.	Baseline to approximately 1 week
Changes in dynamic lung compliance post intervention	After therapy until extubation.	Baseline to approximately 1 week
Changes in oxygen requirements post intervention	After therapy until extubation.	Baseline to approximately 1 week
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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Steven Donn, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2020
• Primary Completion (Actual): June 12, 2020
• Study Completion (Actual): June 12, 2020

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Norwood procedure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Hypoplastic Left Heart Syndrome; Respiratory System Agents; Pulmonary Surfactants; Poractant alfa
• Other Study ID Numbers: HUM00160492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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