Please select the eligibility criteria that correspond to the clinical trial below.
Title: STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS)
Brief Summary: This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD), safety and efficacy of methylprednisolone in infants undergoing heart surgery with cardiopulmonary bypass. This is a prospective, double blind, multi-center, placebo-controlled safety and efficacy study. Blood samples will be collected from a subset of enrolled study participants to evaluate multiple dose methylprednisolone PK/PD. Participants will be randomized in a 1:1 fashion to intravenous methylprednisolone versus placebo. Study drug/placebo will be administered 8 to 12 hours before the anticipated start time of surgery and in the operating room at the time of initiation of cardiopulmonary bypass. Patients will be followed for primary and secondary outcomes for the duration of their hospitalization. Serious study drug-related adverse events will be collected for 7 days after the last dose of study drug.


Options:
A: Inclusion Criteria:

1. Neonate (\< 28 days old) undergoing correct cardiac surgery, or infants undergoing the following surgery procedures: Norwood, Arterial Switch, Total Anomalous Pulmonary Venous Return Repair, Interrupted Aortic Arch Repair, Truncus Arteriosus Repair
2. Successfully weaned off cardiopulmonary bypass after cardiac surgery

Exclusion Criteria:

1. requirement for extracorporeal membrane oxygenation (ECMO) in the operating room
2. Known immune deficiency
3. Having previously received systemic steroids (except for two routine preoperative doses)
4. A current signed Do not resuscitate (DNR) or limitation of care order
5. Current enrollment in another interventional clinical study
6. Refusal of parental consent
7. Previous diagnosis of adrenal insufficiency
8. \> 28 days old at time of surgery whose repair dose not require CPB
B: Inclusion Criteria:

* Neonates Age \</= 1 month
* Scheduled to undergo cardiac surgery involving Cardiopulmonary Bypass (CPB) (reparative or palliative procedures)
* Inpatient Status at MUSC a minimum of 8 hours prior to planned surgery

Exclusion Criteria:

* Prematurity: \</= 36 weeks post gestational age at time of surgery
* Treatment with steroids, other than inhaled forms, in the two weeks prior to scheduled surgery
* Participation in research studies involving the evaluation of investigational drugs within 30 days of randomization
* Suspected infection that would contraindicate steroid use (eg - Herpes)
* Known hypersensitivity to IVMP or one of its components or other contraindication to steroid therapy (e.g., gastrointestinal bleeding)
* Preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization
* Inability to begin the pre-operative study drug at least 8 hours prior to surgery
C: Inclusion Criteria:

1. Age greater than 18 years
2. Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures)
3. Must have a EuroSCORE ≥ 6
4. Provide written informed consent

NOTE: For participating sites in India, China and Hong Kong, the following eligibility criteria will be applied:

1. Age greater than 18 years
2. Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures)
3. Must have at least one of the following:

   1. EuroSCORE greater than or equal to 4 and undergoing valvular surgery
   2. EuroSCORE greater than or equal to 6 and undergoing any other cardiac surgery procedure (i.e. CABG, Aorta)
4. Provide written informed consent

Exclusion Criteria:

1. Use of systemic corticosteroids
2. History of bacterial or fungal infection in last 30 days
3. Allergy/intolerance to corticosteroids
4. Will receive Aprotinin
5. Previous participation in study
D: Inclusion Criteria:

* Age \< 1 year at the time of surgery
* Undergoing heart surgery with CPB as part of standard clinical care
* Availability and willingness of the parent/legally authorized representative to provide written informed consent

Exclusion Criteria:

* \< 37 weeks adjusted gestational age at time of surgery
* Any oral or intravenous steroid treatment within two days of surgery
* Any patient receiving any of the following medications within 2 days of surgery:

Amphotericin B, aminoglutethimide, anticholinesterases, warfarin, P450 3A4 inducers including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifampin, bosentan and nafcillin or P450 3A4 inhibitors including (but not limited to) clarithromycin, voriconazole, itraconazole, ketoconazole, ciprofloxacin, diltiazem, fluconazole, erythromycin and verapamil.

* Infection contraindicating steroid use
* Preoperative mechanical circulatory support or active resuscitation at the time of randomization
* Emergent surgery precluding steroid administration 8-12 hours before surgery

Answer: D