Multicentre online registration of bronchopulmonary dysplasia in very preterm infants in China: protocol for a prospective, open, observational cohort study
Introduction 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...
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2024-11-01
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| author | Ping Zhou Cheng Chen Xin Guo Zhangbin Yu Fei Hu Jiebo Liu Yanping Guo Dan Dan Rao Shengnan He Haibo Peng Xudong Yan Qian Su Boshi Yu Yubai Li |
| author_facet | Ping Zhou Cheng Chen Xin Guo Zhangbin Yu Fei Hu Jiebo Liu Yanping Guo Dan Dan Rao Shengnan He Haibo Peng Xudong Yan Qian Su Boshi Yu Yubai Li |
| author_sort | Ping Zhou |
| collection | DOAJ |
| description | Introduction 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.Methods 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.Ethics and dissemination 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.Trial registration number Chinese Clinical Trial Registry (ChiCTR2400081615). |
| format | Article |
| id | doaj-art-ef8142e3d35a48519037664eaf8b0ec8 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-ef8142e3d35a48519037664eaf8b0ec82025-08-20T02:37:33ZengBMJ Publishing GroupBMJ Open2044-60552024-11-01141110.1136/bmjopen-2024-085560Multicentre online registration of bronchopulmonary dysplasia in very preterm infants in China: protocol for a prospective, open, observational cohort studyPing Zhou0Cheng Chen1Xin Guo2Zhangbin Yu3Fei Hu4Jiebo Liu5Yanping Guo6Dan Dan Rao7Shengnan He8Haibo Peng9Xudong Yan10Qian Su11Boshi Yu12Yubai Li13School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China3 Neonatology, Longgang District Maternity & Child Healthcare Hospital of Shenzhen City, Shenzhen, Guangdong, China3 Neonatology, Longgang District Maternity & Child Healthcare Hospital of Shenzhen City, Shenzhen, Guangdong, China2 Neonatology, Shenzhen People`s Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong, China1 Neonatology, Shenzhen Baoan Women`s and Children`s Hospital, Shenzhen, Guangdong, China5 Neonatology, Shenzhen Luohu Hospital Group Luohu People`s Hospital, Shenzhen, Guangdong, China4 Neonatology, Peking University Shenzhen Hospital, Shenzhen, Guangdong, China5 Neonatology, Shenzhen Luohu Hospital Group Luohu People`s Hospital, Shenzhen, Guangdong, China1 Neonatology, Shenzhen Baoan Women`s and Children`s Hospital, Shenzhen, Guangdong, China1 Neonatology, Shenzhen Baoan Women`s and Children`s Hospital, Shenzhen, Guangdong, China2 Neonatology, Shenzhen People`s Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong, China2 Neonatology, Shenzhen People`s Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong, China2 Neonatology, Shenzhen People`s Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong, China2 Neonatology, Shenzhen People`s Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong, ChinaIntroduction 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.Methods 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.Ethics and dissemination 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.Trial registration number Chinese Clinical Trial Registry (ChiCTR2400081615).https://bmjopen.bmj.com/content/14/11/e085560.full |
| spellingShingle | Ping Zhou Cheng Chen Xin Guo Zhangbin Yu Fei Hu Jiebo Liu Yanping Guo Dan Dan Rao Shengnan He Haibo Peng Xudong Yan Qian Su Boshi Yu Yubai Li Multicentre online registration of bronchopulmonary dysplasia in very preterm infants in China: protocol for a prospective, open, observational cohort study BMJ Open |
| title | Multicentre online registration of bronchopulmonary dysplasia in very preterm infants in China: protocol for a prospective, open, observational cohort study |
| title_full | Multicentre online registration of bronchopulmonary dysplasia in very preterm infants in China: protocol for a prospective, open, observational cohort study |
| title_fullStr | Multicentre online registration of bronchopulmonary dysplasia in very preterm infants in China: protocol for a prospective, open, observational cohort study |
| title_full_unstemmed | Multicentre online registration of bronchopulmonary dysplasia in very preterm infants in China: protocol for a prospective, open, observational cohort study |
| title_short | Multicentre online registration of bronchopulmonary dysplasia in very preterm infants in China: protocol for a prospective, open, observational cohort study |
| title_sort | multicentre online registration of bronchopulmonary dysplasia in very preterm infants in china protocol for a prospective open observational cohort study |
| url | https://bmjopen.bmj.com/content/14/11/e085560.full |
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