NITRIC
Trial question
What is the role of nitric oxide administration in infants during cardiopulmonary bypass surgery for congenital heart disease?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 927
927 patients (411 female, 516 male).
Inclusion criteria: infants < 2 years who underwent open heart surgery with cardiopulmonary bypass for congenital heart disease.
Key exclusion criteria: extracorporeal life support immediately prior to surgery; ongoing treatment with antimicrobials for confirmed or suspected sepsis or septic shock diagnosed within 48 hours prior to the time of surgery; chronic ventilator dependency; methemoglobinemia; ARDS requiring high-frequency oscillation ventilation within 48 hours prior to surgery.
Interventions
N=462 nitric oxide (cardiopulmonary bypass with 20 ppm nitric oxide in the oxygenator).
N=465 standard care (standard cardiopulmonary bypass).
Primary outcome
Neurodevelopment, assessed by Ages and Stages Questionnaire, Third Edition total score
196.6 points
198.7 points
198.7 points
149.0 points
99.3 points
49.7 points
0.0 points
Nitric
oxide
Standard
care
No significant
difference ↔
No significant difference in neurodevelopment, assessed by Ages and Stages Questionnaire, Third Edition total score (196.6 points vs. 198.7 points; MD -2.24, 95% CI -11.84 to 7.36).
Secondary outcomes
Borderline significant decrease in modified Pediatric Overall Performance Category of moderate-to-severe disability (14.7% vs. 15.3%; OR 0.03, 95% CI -0.38 to 0.44).
No significant difference in mean Pediatric QoL Inventory score (74.2 points vs. 75 points; MD -0.81, 95% CI -2.73 to 1.12).
No significant difference in death or neurodevelopment impairment at 12 months (30.3% vs. 30.9%; OR 0.98, 95% CI 0.74 to 1.28).
Conclusion
In infants < 2 years who underwent open heart surgery with cardiopulmonary bypass for congenital heart disease, nitric oxide was not superior to standard care with respect to neurodevelopment, assessed by Ages and Stages Questionnaire, Third Edition total score.
Reference
Debbie A Long, Kristen S Gibbons, Stephen B Horton et al. Neurodevelopmental Outcomes After Nitric Oxide During Cardiopulmonary Bypass for Open Heart Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2458040.
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