Neonatology, Shenzhen Baoan Women's and Children's Hospital, Shenzhen, Guangdong, China.
Neonatology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong, China.
BMJ Open. 2024 Nov 24;14(11):e085560. doi: 10.1136/bmjopen-2024-085560.
Bronchopulmonary dysplasia (BPD) in very preterm infants (VPIs) has adverse long-term outcomes and affects the quality of survival. There are no registry studies on BPD in VPIs in China. Our aim was to conduct a prospective, multicentre, open, longitudinal, observational cohort study to investigate the epidemiological characteristics, diagnosis, treatment, and short-term and long-term outcomes of BPD in a real-life setting in China and lay the grounds for establishing a nationwide registry with clinical data and biological specimens.
This study aims to recruit a minimum of 2000 VPIs and start research in January 2024 in Shenzhen, China. We will collect clinical data from the beginning of the life of VPIs and follow them up to 3 years old. Short-term outcomes, such as the incidence of BPD, necrotising enterocolitis, retinopathy of prematurity, intraventricular haemorrhage and porencephalic ventricular leukomalacia, as well as the cost of hospitalisation, are the major variables of concern. Bayley-III Scale assessment, gross motor function and pulmonary function evaluation will be performed at the age of correction, that is, 18-24 months and 30-36 months. The follow-up outcomes include loss to follow-up, survival status, moderate-to-severe neurodevelopmental deficits and severe respiratory complications. Cord blood, peripheral blood, tracheal aspirate, faeces and urine from VPIs, as well as mother's milk, will be collected and stored at -80°C. All the data will be registered, stored and managed in a cloud-based database. This knowledge will be useful for establishing diagnostic criteria and predictive models for BPD in the Chinese population.
Our protocol has been approved by the Medical Ethics Committee of Shenzhen People's Hospital (LL-KY-2023174-02) and the local ethics committee of each participating centre. Our goal is to present our findings at national conferences and in peer-reviewed paediatric journals.
Chinese Clinical Trial Registry (ChiCTR2400081615).
极早产儿支气管肺发育不良（BPD）存在不良的长期预后，并影响生存质量。目前中国尚无极早产儿 BPD 的登记研究。本研究旨在开展一项前瞻性、多中心、开放、纵向、观察性队列研究，以调查中国真实世界中极早产儿 BPD 的流行病学特征、诊断、治疗及近期和远期结局，并为建立包含临床数据和生物标本的全国性登记研究奠定基础。
本研究计划在 2024 年 1 月于中国深圳招募至少 2000 例极早产儿，并开始研究。我们将从极早产儿生命开始时收集临床数据，并对其进行随访至 3 岁。近期结局，如 BPD、坏死性小肠结肠炎、早产儿视网膜病变、脑室内出血和脑穿通畸形的发生率，以及住院费用等，是主要关注的变量。在矫正年龄（18-24 个月和 30-36 个月）时，将进行贝利 III 量表评估、粗大运动功能和肺功能评估。随访结局包括失访、生存状态、中重度神经发育缺陷和严重呼吸系统并发症。将采集极早产儿的脐血、外周血、气管抽吸物、粪便和尿液，以及母亲的乳汁，并在-80°C 下储存。所有数据将在云端数据库中进行注册、存储和管理。这些知识将有助于在中国人群中建立 BPD 的诊断标准和预测模型。
我们的方案已获得深圳市人民医院医学伦理委员会（LL-KY-2023174-02）和各参与中心当地伦理委员会的批准。我们的目标是在全国会议和同行评议的儿科期刊上展示我们的研究结果。
中国临床试验注册中心（ChiCTR2400081615）。
