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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 : January 10, 2020
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Steven Donn, M.D., 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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Hypoplastic Left Heart Syndrome Drug: Curosurf Drug: Sham Phase 1

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.

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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
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. Number of days in the Pediatric Cardiothoracic Unit [ Time Frame: Approximately 11 days ]
    From time of admission until transfer out of the unit.

  3. Number of post-operative hospital days [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure [ Time Frame: Up to 1 year ]
    Post-surgery throughout hospitalization.

  4. Changes in positive end-expiratory pressures post intervention [ Time Frame: Baseline to approximately 1 week ]
    After therapy until extubation.

  5. Changes in peak inspiratory pressures post intervention [ Time Frame: Baseline to approximately 1 week ]
    After therapy until extubation.

  6. Changes in dynamic lung compliance post intervention [ Time Frame: Baseline to approximately 1 week ]
    After therapy until extubation.

  7. Changes in oxygen requirements post intervention [ Time Frame: Baseline to approximately 1 week ]
    After therapy until extubation.

  8. 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.

  9. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Diane White 734-615-7840 dfwhite@umich.edu
Contact: Steven Donn, MD 734-232-0334 smdonnmd@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Diane White    734-615-7840    dfwhite@umich.edu   
Sponsors and Collaborators
University of Michigan
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Steven Donn, MD University of Michigan

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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: January 10, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Steven Donn, M.D., University of Michigan:
Norwood procedure
Additional relevant MeSH terms:
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Heart Diseases
Hypoplastic Left Heart Syndrome
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pulmonary Surfactants
Poractant alfa
Respiratory System Agents