Paediatrics, Sinai Health System, Toronto, Ontario, Canada.
Newborn and Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
BMJ Open. 2021 Mar 31;11(3):e044924. doi: 10.1136/bmjopen-2020-044924.
Although chronic pulmonary hypertension (cPH) secondary to chronic neonatal lung disease is associated with increased mortality and respiratory and neurodevelopmental morbidities, late diagnosis (typically ≥36 weeks postmenstrual age, PMA) and the use of qualitative echocardiographic diagnostic criterion (flat interventricular septum in systole) remain significant limitations in clinical care. Our objective in this study is to evaluate the utility of relevant quantitative echocardiographic indices to identify cPH in preterm neonates, early in postnatal course and to develop a diagnostic test based on the best combination of markers.
In this ongoing international prospective multicentre observational diagnostic accuracy study, we aim to recruit 350 neonates born <27 weeks PMA and/or birth weight <1000 g and perform echocardiograms in the third week of age and at 32 weeks PMA (early diagnostic assessments, EDA) in addition to the standard diagnostic assessment (SDA) for cPH at 36 weeks PMA. Predefined echocardiographic markers under investigation will be measured at each EDA and examined to create a scoring system to identify neonates who subsequently meet the primary outcome of cPH/death at SDA. Diagnostic test characteristics will be defined for each EDA. Pulmonary artery acceleration time and tricuspid annular plane systolic excursion are the primary markers of interest.
Ethics approval has been received by the Mount Sinai Hospital Research Ethics Board (REB) (#16-0111-E), Sunnybrook Health Sciences Centre REB (#228-2016), NHS Health Research Authority (IRAS 266498), University of Iowa Human Subjects Office/Institutional Review Board (201903736), Rotunda Hospital Research and Ethics Committee (REC-2019-008), and UBC Children's and Women's REB (H19-02738), and is under review at Boston Children's Hospital Institutional Review Board. Study results will be disseminated to participating families in lay format, presented to the scientific community at paediatric and critical care conferences and published in relevant peer-reviewed journals.
NCT04402645.
尽管慢性新生儿肺疾病引起的慢性肺动脉高压（cPH）与死亡率增加以及呼吸和神经发育并发症有关，但晚期诊断（通常≥36 周校正胎龄，PMA）和使用定性超声心动图诊断标准（收缩期室间隔平坦）仍然是临床护理中的重要限制。本研究的目的是评估相关定量超声心动图指标在识别早产儿 cPH 中的效用，以便在出生后早期，并基于最佳标志物组合开发诊断测试。
在这项正在进行的国际前瞻性多中心观察性诊断准确性研究中，我们计划招募 350 名出生时 PMA<27 周和/或出生体重<1000g 的新生儿，并在出生后第三周和 32 周 PMA 时进行超声心动图检查（早期诊断评估，EDA），以及在 36 周 PMA 时进行 cPH 的标准诊断评估（SDA）。将在每个 EDA 测量正在研究的预设超声心动图标志物，并进行检查以创建评分系统，以识别随后在 SDA 时符合 cPH/死亡主要结局的新生儿。将为每个 EDA 定义诊断测试特征。肺动脉加速度时间和三尖瓣环平面收缩期位移是主要感兴趣的标志物。
已获得西奈山医院研究伦理委员会（REB）（#16-0111-E）、桑尼布鲁克健康科学中心 REB（#228-2016）、NHS 健康研究管理局（IRAS 266498）、爱荷华大学人类受试者办公室/机构审查委员会（201903736）、罗顿医院研究和伦理委员会（REC-2019-008）和不列颠哥伦比亚大学妇女儿童医院伦理委员会（H19-02738）的批准，并正在波士顿儿童医院机构审查委员会审查中。研究结果将以通俗易懂的格式传达给参与的家庭，并在儿科和危重病会议上向科学界介绍，并在相关同行评议期刊上发表。
NCT04402645。
