School of Nursing, Queensland University of Technology, Kelvin Grove, Queensland, Australia.
Paediatric Intensive Care Unit, Queensland Children's Hospital, South Brisbane, Queensland, Australia.
BMJ Open. 2023 Aug 30;13(8):e075429. doi: 10.1136/bmjopen-2023-075429.
Despite growing awareness of neurodevelopmental impairments in children with congenital heart disease (CHD), there is a lack of large, longitudinal, population-based cohorts. Little is known about the contemporary neurodevelopmental profile and the emergence of specific impairments in children with CHD entering school. The performance of standardised screening tools to predict neurodevelopmental outcomes at school age in this high-risk population remains poorly understood. The NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial randomised 1371 children <2 years of age, investigating the effect of gaseous nitric oxide applied into the cardiopulmonary bypass oxygenator during heart surgery. The NITRIC follow-up study will follow this cohort annually until 5 years of age to assess outcomes related to cognition and socioemotional behaviour at school entry, identify risk factors for adverse outcomes and evaluate the performance of screening tools.
Approximately 1150 children from the NITRIC trial across five sites in Australia and New Zealand will be eligible. Follow-up assessments will occur in two stages: (1) annual online screening of global neurodevelopment, socioemotional and executive functioning, health-related quality of life and parenting stress at ages 2-5 years; and (2) face-to-face assessment at age 5 years assessing intellectual ability, attention, memory and processing speed; fine motor skills; language and communication; and socioemotional outcomes. Cognitive and socioemotional outcomes and trajectories of neurodevelopment will be described and demographic, clinical, genetic and environmental predictors of these outcomes will be explored.
Ethical approval has been obtained from the Children's Health Queensland (HREC/20/QCHQ/70626) and New Zealand Health and Disability (21/NTA/83) Research Ethics Committees. The findings will inform the development of clinical decision tools and improve preventative and intervention strategies in children with CHD. Dissemination of the outcomes of the study is expected via publications in peer-reviewed journals, presentation at conferences, via social media, podcast presentations and medical education resources, and through CHD family partners.
The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry as 'Gene Expression to Predict Long-Term Neurodevelopmental Outcome in Infants from the NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) Study - A Multicentre Prospective Trial'.
ACTRN12621000904875.
尽管人们越来越意识到先天性心脏病（CHD）患儿存在神经发育障碍，但缺乏大规模、纵向、基于人群的队列研究。对于即将入学的 CHD 患儿，目前对其当代神经发育特征以及特定障碍的出现知之甚少。对于高危人群，标准化筛查工具在预测学龄期神经发育结局方面的表现仍知之甚少。NITRIC 试验（在体外循环期间使用一氧化氮改善先天性心脏病患儿的恢复）将 1371 名<2 岁的患儿随机分为两组，分别研究在心脏手术期间将气态一氧化氮应用于体外循环氧合器对患儿的影响。NITRIC 随访研究将每年对该队列进行随访，直至 5 岁，以评估入学时认知和社会情感行为相关的结局、识别不良结局的危险因素，并评估筛查工具的性能。
澳大利亚和新西兰的五个地点的 NITRIC 试验中约有 1150 名患儿符合条件。随访评估将分两个阶段进行：（1）在 2-5 岁时每年在线筛查患儿的总体神经发育、社会情感和执行功能、健康相关生活质量和育儿压力；（2）在 5 岁时进行面对面评估，评估患儿的智力、注意力、记忆力和处理速度、精细运动技能、语言和沟通以及社会情感结局。将描述神经发育的认知和社会情感结局和轨迹，并探讨这些结局的人口统计学、临床、遗传和环境预测因素。
昆士兰儿童健康（HREC/20/QCHQ/70626）和新西兰健康和残疾（21/NTA/83）研究伦理委员会已批准该试验。研究结果将为 CHD 患儿的临床决策工具的开发提供信息，并改善预防和干预策略。预计将通过在同行评议期刊上发表文章、在会议上展示、通过社交媒体、播客展示和医学教育资源以及通过 CHD 家庭合作伙伴进行研究结果的传播。
该试验前瞻性地在澳大利亚和新西兰临床试验注册中心注册，名称为“基因表达预测体外循环期间一氧化氮对先天性心脏病患儿恢复的影响（NITRIC）研究中婴儿的长期神经发育结局——一项多中心前瞻性试验”。
ACTRN12621000904875。
