Pediatric anesthesia & critical care
Neurodevelopmental Outcomes After Nitric Oxide During Cardiopulmonary Bypass for Open Heart Surgery: A Randomized Clinical Trial
Primary result · ASQ-3 total scoreResult — go to the resultAdjusted mean difference −2.24 95% CI −11.84 to 7.36Authors' conclusion
In this randomized clinical trial of infants with congenital heart disease, NO administered via the CPB oxygenator did not improve neurodevelopmental outcomes or HRQOL 12 months after open heart surgery.
Study context
- Population
- Infants <2 years undergoing open heart surgery with cardiopulmonary bypass (CPB) for congenital heart disease; 6 centres in Australia, New Zealand and the Netherlands927 followed up
- Participants
- 1,364 infants
- Comparison
- Nitric oxide (NO) 20 ppm into the CPB oxygenator vs standard CPB
- NOn = 462
- Standard caren = 465reference
- Primary endpoint
- Neurodevelopment (ASQ-3 total score)
- Follow-up
- 12 months post surgery
Methodological detailspreplanned 12-month follow-up, double-masked, multicentre, preplanned prospective follow-up
- Preplanned 12-month follow-up
- Double-masked
- Multicentre
- Preplanned prospective follow-up
Primary result
ASQ-3 total score · 12 months
Adjusted mean difference
−2.24
95% CI −11.84 to 7.36
By group
NO
196.6
mean · SD 75.4
Standard care
198.7
mean · SD 73.8
NO vs Standard care
adjusted mean difference −2.24 (95% CI −11.84 to 7.36)
As reported in the abstract
Secondary outcomes
Health-related quality of life (HRQOL) (Pediatric Quality of Life Inventory) and functional status (modified Pediatric Overall Performance Category) · 12 months
- No differences in secondary outcomes
Factors associated with lower ASQ-3 total score
- Prematurity (gestational age <37 weeks), univentricular lesions, congenital syndromes and longer ICU LOS associated with lower ASQ-3 total scores (adjusted multivariable analyses)
Original publication
Neurodevelopmental Outcomes After Nitric Oxide During Cardiopulmonary Bypass for Open Heart Surgery: A Randomized Clinical Trial. JAMA Netw Open. Published 3 February 2025. doi:10.
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