Namba Fumihiko, Tanaka Kosuke, Omori Sayu, Ikeda Kazushige, Kawabata Ken, Sato Hiroaki, Honda Masakazu, Ichikawa Tomonori, Minosaki Yoshihiro, Michikawa Takehiro, Oka Shuntaro, Kabe Kazuhiko
Department of Pediatrics, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Division of Neonatology, Department of Pediatrics, Saitama City Hospital, Saitama, Japan.
JMIR Res Protoc. 2021 Mar 5;10(3):e22948. doi: 10.2196/22948.
Because of the improvements in survival rates for preterm infants, not only the rates of bronchopulmonary dysplasia (BPD) but also those of long-term respiratory complications of premature birth are increasing, resulting in financial and health burdens in developed countries. Thus far, the risk factors of respiratory morbidities in extremely preterm infants remain unknown. Furthermore, the definition and the predictive ability of BPD for long-term respiratory outcomes are yet to be determined.
The objective of our study, Extreme Prematurity and Pulmonary Outcomes Program in Saitama, is to develop the diagnostic criteria for BPD and to determine the prognostic factors contributing to the long-term pulmonary outcomes manifesting in extremely preterm infants.
The Extreme Prematurity and Pulmonary Outcomes Program in Saitama is an observational prospective cohort study performed by a consortium of six neonatal intensive care units (NICUs) in Saitama, Japan. The subjects included in this study are infants (from each clinical center) with gestational ages 22 to 27 weeks. The target is 400 subjects. This study aims to determine the definition of BPD and other perinatal factors that accurately predict the long-term pulmonary outcomes in survivors of extreme prematurity. Moreover, the association between BPD and postprematurity respiratory disease will be investigated using generalized linear models.
The protocol and consent forms were evaluated and approved on September 5, 2019, by the Ethics Committee of Saitama Medical Center, Saitama Medical University. Enrollment began on April 1, 2020. It is expected to end on March 31, 2023. The follow-up for 1 year corrected age is expected to continue through the middle of 2024.
The Extreme Prematurity and Pulmonary Outcomes Program in Saitama incorporates aspects of neonatal care in secondary- and tertiary-level NICUs to develop existing research studies on the definition of BPD, objective biomarkers, and outcome measures of respiratory morbidity in extremely preterm infants beyond NICU hospitalization, thereby leading to a novel understanding of the nature and natural history of BPD and potential mechanistic and therapeutic targets in at-risk subjects.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/22948.
由于早产儿存活率的提高，不仅支气管肺发育不良（BPD）的发生率增加，早产的长期呼吸并发症发生率也在上升，给发达国家带来了经济和健康负担。迄今为止，极早产儿呼吸疾病的危险因素仍不清楚。此外，BPD对长期呼吸结局的定义和预测能力尚未确定。
我们在埼玉开展的极早产与肺部结局项目研究的目的是制定BPD的诊断标准，并确定导致极早产儿出现长期肺部结局的预后因素。
埼玉极早产与肺部结局项目是一项观察性前瞻性队列研究，由日本埼玉县的六个新生儿重症监护病房（NICU）组成的联盟进行。本研究纳入的对象为（来自各临床中心）胎龄22至27周的婴儿。目标是400名受试者。本研究旨在确定BPD的定义以及其他围产期因素，这些因素能够准确预测极早产儿幸存者的长期肺部结局。此外，将使用广义线性模型研究BPD与足月后呼吸疾病之间的关联。
该方案和知情同意书于2019年9月5日经埼玉医科大学埼玉医疗中心伦理委员会评估并批准。2020年4月1日开始招募。预计于2023年3月31日结束。对1年矫正年龄的随访预计将持续到2024年年中。
埼玉极早产与肺部结局项目纳入了二级和三级NICU的新生儿护理方面，以开展现有的关于BPD定义、客观生物标志物以及极早产儿NICU住院后呼吸疾病结局指标的研究，从而对BPD的性质和自然史以及高危受试者潜在的机制和治疗靶点有新的认识。
国际注册报告识别码（IRRID）：DERR1-10.2196/22948
