Congenital Heart Disease, Hypoplastic Left Heart Syndrome
Conditions
Keywords
Norwood procedure
Brief 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.
Detailed 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.
Interventions
DRUGCurosurf
This arm will consist of a single dose of Curosurf (200 mg/kg) that will be given in the Pediatric Cardiothoracic Unit (PCTU) after surgery once the subject has reached a normalized body temperature.
DRUGSham
This arm will consist of a single dose of sham (air) that will be given through the endotracheal tube in the Pediatric Cardiothoracic Intensive Care Unit after surgery once the subject has reached a normalized body temperature.
Sponsors
Chiesi Farmaceutici S.p.A.
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days of mechanical ventilation | Throughout hospitalization (approximate average 5 days) | This will be the number of days from intubation to the extubation date. |
| Number of days in the Pediatric Cardiothoracic Unit | Approximately 11 days | From time of admission until transfer out of the unit. |
| Number of post-operative hospital days | Up to 1 year | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in positive end-expiratory pressures post intervention | Baseline to approximately 1 week | After therapy until extubation. |
| Changes in peak inspiratory pressures post intervention | Baseline to approximately 1 week | After therapy until extubation. |
| Changes in dynamic lung compliance post intervention | Baseline to approximately 1 week | After therapy until extubation. |
| Total number of patients requiring thoracostomy tube placement for air leak not associated with standard post-operative management prior to extubation | Approximately 1 week | Post-surgery prior to extubation. |
| Changes in oxygenation index (OI) post intervention | Baseline to approximately 1 week | OI is the product of mean airway pressure and fraction of inspired oxygen divided by the partial pressure of oxygen. After therapy until extubation. |
| Time to successful extubation readiness trials (ERT) post intervention | Approximately 1 week | Measured in hours until successful ERT, and then successful extubation. Not everyone who passes an ERT is immediately extubated (typically done once per day), so the plan is daily. Successful extubation is defined as remaining extubated for 48 hours. |
| Changes in oxygen requirements post intervention | Baseline to approximately 1 week | After therapy until extubation. |
| Total number of patients requiring high frequency ventilation (HFV) (High frequency oscillator ventilation or High frequency jet ventilation) | Up to 1 year | Post-surgery throughout hospitalization. |
| Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure | Up to 1 year | Post-surgery throughout hospitalization. |
Countries
United States
Outcome results
None listed