Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04181255
Study type	Interventional
Source	University of Michigan
Contact
Status	Terminated
Phase	Phase 1
Start date	February 25, 2020
Completion date	June 12, 2020

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