Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: Chiesi Farmaceutici S.p.A.
• Treatments: Poractant alfa; Pulmonary Surfactants

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.