A clinical trial to study the risk factors of bronchopulmonary dysplasia in Chinese preterm infants
ISRCTN | ISRCTN84167642 |
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DOI | https://doi.org/10.1186/ISRCTN84167642 |
Secondary identifying numbers | 2019-IRB-164 1.0; ChiCTR2000030125 |
- Submission date
- 18/02/2020
- Registration date
- 25/02/2020
- Last edited
- 04/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
Bronchopulmonary dysplasia (BPD) remains one of the principal causes of death and respiratory problems in very premature infants (<32 weeks of gestation) both during hospitalization and in the first years of life. The aim of this study is to explore the risk factors for BPD in the population of Chinese very preterm infants.
Who can participate?
Preterm infants admitted within 72 hours after birth, gestational age <32 weeks and respiratory distress score ≥5
What does the study involve?
This study will collect data from 39 NICUs of tertiary hospitals in China, including obstetric conditions, relevant records during delivery, and materials of respiratory support, drug application, infection status, circulation management and nutritional fluid after birth. The primary outcomes of this study are early death (between 14 days of postnatal age and 36 weeks PMA) and BPD (36 weeks PMA), the secondary outcomes are the grade and severity of BPD.
What are the possible benefits and risks of participating?
There are no direct benefits or risks of taking part in this study, but it is hoped that the study will inform researchers examine the risk factors of BPD, and provide the evidence-based support for follow-up research.
Where is the study run from?
The Children's Hospital Zhejiang University School of Medicine (China)
When is the study starting and how long is it expected to run for?
January 2020 to December 2021
Who is funding the study?
China National Clinical Research Center for Child Health/China National Children’s Regional Medical Center
Who is the main contact?
Dr Zheng Chen
chenz@zju.edu.cn
Contact information
Scientific
Principal Investigator
3333 Binsheng Road
HangZhou
310052
China
Phone | +86 (0)571 86670704 |
---|---|
chenz@zju.edu.cn |
Study information
Study design | Multicenter prospective cohort study |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Screening |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
Scientific title | Risk factors for bronchopulmonary dysplasia in preterm infants - a multicenter prospective cohort study in China |
Study acronym | RFBPD-CHN |
Study objectives | This study will explore the risk factors of BPD according to the 2018 NICHD definition, and provide the evidence-based support for follow-up research. |
Ethics approval(s) | Approved 24/12/2019, medical ethics committee of The Children's Hospital Zhejiang University School of Medicine (No. 3333 Binsheng Road, HangZhou, Zhejiang, China, 310052; +86 (0)571 86670072; zuchiec@163.com), ref: 2019-IRB-164 |
Health condition(s) or problem(s) studied | Bronchopulmonary dysplasia in preterm infants |
Intervention | This study will collect the data from 39 NICU of tertiary hospitals in China, including obstetric conditions, relevant records during delivery, and materials of respiratory support, drug application, infection status, circulation management and nutritional fluid after birth. The total duration of observation is from birth to 36 weeks postmenstrual age (PMA) after birth. There is no follow-up after endpoint of the study. |
Intervention type | Other |
Primary outcome measure | 1. Early death (between 14 days of postnatal age and 36 weeks PMA) measured using data from medical records, defined as owing to persistent parenchymal lung disease and respiratory failure that cannot be attributable to other neonatal morbidities (eg, necrotizing enterocolitis, intraventricular hemorrhage, redirection of care, episodes of sepsis, etc) 2. BPD at 36 weeks PMA measured using data from medical records, defined as a premature infant (<32 weeks’ gestational age) with persistent parenchymal lung disease confirmed by radiography, and at 36 weeks PMA requires oxygen for ≥3 consecutive days to maintain arterial oxygen saturation in the 90%–95% range The incidence of early death and BPD are calculated by the corresponding rate for the total study population in the database |
Secondary outcome measures | The grade and severity of BPD according to the definition of 2018 NICHD BPD workshop at 36 weeks PMA |
Overall study start date | 01/01/2020 |
Completion date | 31/12/2021 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | This study will recruit more than 1000 patients |
Key inclusion criteria | Preterm infants admitted within 72 hours after birth, gestational age <32 weeks and respiratory distress score ≥5 |
Key exclusion criteria | Congenital malformations such as complex congenital heart disease, diaphragmatic hernia, anomalies of digestive tract/kidney, and genetic metabolic disorders |
Date of first enrolment | 01/03/2020 |
Date of final enrolment | 28/02/2021 |
Locations
Countries of recruitment
- China
Study participating centres
Hangzhou
310052
China
Chongqing
400014
China
Hangzhou
310006
China
Shanghai
200062
China
Nanjing
210011
China
Ningbo
315012
China
Shenzhen
518028
China
Changchun
130021
China
Shijiazhuang
050082
China
Beijing
100039
China
Beijing
100016
China
Beijing
100191
China
Quzhou
362000
China
Chongqing
401147
China
Chengdu
610074
China
Guiyang
550003
China
Nanning
530021
China
Nanning
530007
China
Nanning
530002
China
Kunming
650032
China
Kunming
650101
China
Kunming
650228
China
Zhengzhou
450052
China
Zhengzhou
450018
China
Zhengzhou
450003
China
Xian
710068
China
Urumqi
830054
China
Urumqi
830001
China
Xining
810007
China
Hohhot
010017
China
Lanzhou
730050
China
Xuzhou
221002
China
Yulin
537000
China
Luzhou
646600
China
Qujing
655000
China
Taian
271000
China
Yinchuan
750001
China
Mianyang
621000
China
Chongqing
404000
China
Sponsor information
Hospital/treatment centre
3333 Binsheng Road
Hangzhou
310052
China
Phone | +86 (0)571 86670083 |
---|---|
chenz@zju.edu.cn | |
Website | http://www.zjuch.cn |
https://ror.org/025fyfd20 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
Intention to publish date | 31/12/2022 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Findings will be published in relevant medical journals, at conferences and to members of the public via the website of The Children's Hospital Zhejiang University School of Medicine. |
IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Ms Yusang Dong (yusang_dong@zju.edu.cn). All information of the study will be collected on data forms, with data being entered into the Resman research manager database of ChiCTR for subsequent analysis. CNCRCCH (China National Clinical Research Center for Child Health) will save all the study data and complete data analysis. The data will be available when the recruitment start and upload within 3 months later. The data will be available for 3 years since then. Only members of this study will have permission to access the database. The investigators of other participating hospitals will be authorized to share the summary of the data and analyze the results. Data access will comply with privacy regulations, and all data will be kept by a specialist to protect the patients’ privacy. To ensure ethical standards are met, the researchers will obtain informed consent from each participating parent before enrollment and will respect the parents’ decision to join or leave the study at any time. All data will be identified, and the researchers will use patients’ ID numbers instead of names when summarizing data. Qualitative and quantitative data will be collected during the study; nominal, ordinal, interval may also be used during the study. The study is a multi-center clinical study which will include analytics-descriptive predictive analytics and so on. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol file | 06/03/2020 | No | No | ||
Results article | 03/04/2024 | 04/04/2024 | Yes | No |
Additional files
- ISRCTN84167642_PROTOCOL.pdf
- Uploaded 06/03/2020
Editorial Notes
04/04/2024: Publication reference added.
06/03/2020: Uploaded protocol (not peer reviewed)
24/02/2020: Trial's existence confirmed by medical ethics committee of The Children's Hospital Zhejiang University School of Medicine.