TerminatedPhase 1

Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

Stopped: Investigator Retirement

United States2 participantsStarted 2020-02-25

Plain-language 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.

Who can participate

Age range1 Day – 12 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of days of mechanical ventilation

Timeframe: Throughout hospitalization (approximate average 5 days)

Number of days in the Pediatric Cardiothoracic Unit

Timeframe: Approximately 11 days

Number of post-operative hospital days

Timeframe: Up to 1 year

Trial details

NCT IDNCT04181255

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-12

View on ClinicalTrials.gov More Congenital Heart Disease trials