Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04181255 |
Recruitment Status :
Recruiting
First Posted : November 29, 2019
Last Update Posted : April 22, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congenital Heart Disease Hypoplastic Left Heart Syndrome | Drug: Curosurf Drug: Sham | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | The Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy Following Deep Hypothermic Circulatory Arrest During Cardiac Surgery |
Actual Study Start Date : | February 25, 2020 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |

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:
|
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. |
- Number of days of mechanical ventilation [ Time Frame: 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 [ Time Frame: Approximately 11 days ]From time of admission until transfer out of the unit.
- Number of post-operative hospital days [ Time Frame: Up to 1 year ]
- Total number of patients requiring thoracostomy tube placement for air leak not associated with standard post-operative management prior to extubation [ Time Frame: Approximately 1 week ]Post-surgery prior to extubation.
- Total number of patients requiring high frequency ventilation (HFV) (High frequency oscillator ventilation or High frequency jet ventilation) [ Time Frame: Up to 1 year ]Post-surgery throughout hospitalization.
- Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure [ Time Frame: Up to 1 year ]Post-surgery throughout hospitalization.
- Changes in positive end-expiratory pressures post intervention [ Time Frame: Baseline to approximately 1 week ]After therapy until extubation.
- Changes in peak inspiratory pressures post intervention [ Time Frame: Baseline to approximately 1 week ]After therapy until extubation.
- Changes in dynamic lung compliance post intervention [ Time Frame: Baseline to approximately 1 week ]After therapy until extubation.
- Changes in oxygen requirements post intervention [ Time Frame: Baseline to approximately 1 week ]After therapy until extubation.
- Changes in oxygenation index (OI) post intervention [ Time Frame: 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 [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 12 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181255
Contact: Diane White | 734-615-7840 | dfwhite@umich.edu | |
Contact: Steven Donn, MD | 734-232-0334 | smdonnmd@umich.edu |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Diane White 734-615-7840 dfwhite@umich.edu |
Principal Investigator: | Steven Donn, MD | University of Michigan |
Responsible Party: | Steven Donn, M.D., Professor Emeritus of Pediatrics, University of Michigan |
ClinicalTrials.gov Identifier: | NCT04181255 |
Other Study ID Numbers: |
HUM00160492 |
First Posted: | November 29, 2019 Key Record Dates |
Last Update Posted: | April 22, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Norwood procedure |
Heart Diseases Hypoplastic Left Heart Syndrome Cardiovascular Diseases Heart Defects, Congenital Cardiovascular Abnormalities |
Congenital Abnormalities Poractant alfa Pulmonary Surfactants Respiratory System Agents |