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 range

1 Day – 12 Weeks

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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