For a study, researchers sought to compare the impact of nitric oxide with conventional care on the number of days that children receiving surgery for congenital heart disease are ventilator-free.

ABout 6 pediatric cardiac surgery facilities in Australia, New Zealand, and the Netherlands participated in a double-blind, multicenter, randomized clinical study. Between July 2017 and April 2021, 1,371 infants under the age of 2 who were having congenital heart surgery were randomly assigned, and the final participant’s 28-day follow-up was finished on May 24, 2021. Patients were randomly randomized to receive standard care cardiopulmonary bypass without nitric oxide (n = 685) or nitric oxide at 20 ppm administered into the cardiopulmonary bypass oxygenator (n = 679). The number of days without a ventilator between the start of bypass and day 28 served as the major endpoint. A composite of low cardiac output syndrome, extracorporeal life support, or death, the duration of stay in the intensive care unit, the length of stay in the hospital, and postoperative troponin levels were the 4 secondary end goals.

About 1,364 (99.5%) of the 1,371 patients who were randomly assigned to the study (mean [SD] age, 21.2 [23.5] weeks; 587 females [42.8%]) completed it. With a median of 26.6 days (IQR, 24.4 to 27.4) versus 26.4 days (IQR, 24.0 to 27.2), the number of ventilator-free days did not substantially differ between the nitric oxide and standard care groups, with an absolute difference of -0.01 days (95% CI, -0.25 to 0.22; P=.92). With an adjusted odds ratio of 1.12, 22.5% of those in the nitric oxide group and 20.9% of those receiving standard care suffered low cardiac output syndrome within 48 hours, required extracorporeal support within 48 hours, or passed away by day 28. (95% CI, 0.85 to 1.47). There were no significant differences between the groups for further outcomes.

The use of nitric oxide via cardiopulmonary bypass did not substantially affect the number of ventilator-free days in children under the age of 2 who underwent cardiopulmonary bypass surgery for congenital heart disease. The use of nitric oxide injected into the cardiopulmonary bypass oxygenator during cardiac surgery is not supported by these data.