Table 1.
Baseline characteristics of infants enrolled in the NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial
| Characteristic | Standard care N = | Nitric oxide N = |
|---|---|---|
| Age at randomisation (weeks),⁎ median (IQR) | ||
| < 6 weeks, n (%) | ||
| ≥ 6 weeks, n (%) | ||
| Weight (kg), median (IQR) | ||
| Female sex, n (%) | ||
| Ethnicity, n (%) | ||
| Caucasian | ||
| Aboriginal/Torres Strait Islander | ||
| Asian | ||
| Mãori/Pacific Islander | ||
| Mixed/other | ||
| Congenital heart disease, n (%) | ||
| Univentricular⁎ | ||
| Biventricular⁎ | ||
| History of previous cardiac surgery on CPB | ||
| Right-sided obstructive lesions | ||
| Tetralogy of Fallot | ||
| Double outlet right ventricle | ||
| Pulmonary stenosis/atresia | ||
| Tricuspid stenosis/atresia | ||
| Other | ||
| Left-sided obstructive lesions | ||
| Coarctation | ||
| Interrupted aortic arch | ||
| Hypoplastic aortic arch | ||
| HLHS | ||
| Other | ||
| Shunt lesions | ||
| ASD | ||
| VSD | ||
| AVSD | ||
| Truncus | ||
| TGA | ||
| Persistent ductus arteriosus | ||
| Other | ||
| Various lesions | ||
| Double-inlet left ventricle | ||
| TAPVD | ||
| Other | ||
| Current ICU admission and treatments before heart surgery | ||
| Intensive care admission, n (%) | ||
| Duration of ICU stay (days), median (IQR) | ||
| Treatments | ||
| Invasive ventilation, n (%) | ||
| Duration of invasive ventilation (days), median (IQR) | ||
| Tracheostomy, n (%) | ||
| Inotropes, n (%) | ||
| Prostaglandin, n (%) | ||
| Steroids, n (%) | ||
| Afterload reducing agents, n (%) | ||
| Inhaled nitric oxide, n (%) | ||
| Sildenafil, n (%) | ||
| Comorbidities, n (%) | ||
| POPC | ||
| Good/normal | ||
| Functionally normal | ||
| Mild overall disability | ||
| Moderate overall disability | ||
| Severe overall disability | ||
| Coma/vegetative state | ||
| Brain death | ||
| Unknown | ||
| Congenital syndrome | ||
| Trisomy 21 | ||
| 22q11 | ||
| Turner | ||
| Noonan | ||
| VACTERL | ||
| CHARGE | ||
| Other syndrome | ||
| Country of hospital, n (%) | ||
| Australia | ||
| New Zealand | ||
| The Netherlands | ||
| Surgical complexity | ||
| RACHS score, median (IQR) | ||
| RACHS-1, n (%) | ||
| RACHS-2, n (%) | ||
| RACHS-3, n (%) | ||
| RACHS-4, n (%) | ||
| RACHS-5, n (%) | ||
| RACHS-6, n (%) | ||
| Surgical procedure, n (%) | ||
| Tetralogy repair | ||
| Norwood procedure | ||
| Bicavopulmonary shunt | ||
| Right ventricular to pulmonary artery shunt/conduit | ||
| Fontan completion | ||
| Arterial switch operation | ||
| ASD repair | ||
| VSD repair | ||
| AVSD repair | ||
| Aortic arch repair | ||
| Coarctation repair | ||
| Truncus repair | ||
| Pulmonary artery band | ||
| Ross procedure | ||
| Left ventricular outflow tract surgery | ||
| Right ventricular outflow tract surgery | ||
| Valve surgery | ||
| Valve repair | ||
| Anomalous pulmonary vein repair | ||
| Heart transplant | ||
| Other |
ASD = atrial septal defect; AVSD = atrioventricular septal defect; CHARGE = coloboma, heart defects, atresia choanae (also known as choanal atresia), growth retardation, genital abnormalities, and ear abnormalities; CPB = cardiopulmonary bypass; HLHS = hypoplastic left heart syndrome; ICU = intensive care unit; IQR = interquartile range; POPC = Pediatric Overall Performance Category; RACHS = Risk Adjustment for Congenital Heart Surgery; TAPVD = total anomalous pulmonary venous drainage; TGA = transposition of the great arteries; VACTERL = vertebral defects, anal atresia, cardiac defects, tracheoesophageal fistula, renal anomalies, and limb abnormalities; VSD = ventricular septal defect.
Used for stratification.