Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

University of Michigan

Status and phase

Terminated

Phase 1

Conditions

Hypoplastic Left Heart Syndrome

Congenital Heart Disease

Treatments

Drug: Curosurf

Drug: Sham

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04181255

HUM00160492

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

1 day to 12 weeks old

Volunteers

No Healthy Volunteers

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.