Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-25

Study Completion Date

2020-06-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Congenital Heart Disease Hypoplastic Left Heart Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Curosurf

Group Type EXPERIMENTAL

Curosurf

Intervention Type DRUG

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 (air)

Group Type PLACEBO_COMPARATOR

Sham

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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poractant alfa surfactant

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No