Condition category
Neonatal Diseases
Date applied
18/02/2020
Date assigned
25/02/2020
Last edited
06/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

https://www.ncrcch.org/

Contact information

Type

Scientific

Primary contact

Dr Zheng Chen

ORCID ID

Contact details

Principal Investigator
3333 Binsheng Road
HangZhou
310052
China
+86 (0)571 86670704
chenz@zju.edu.cn

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2019-IRB-164 1.0; ChiCTR2000030125

Study information

Scientific title

Risk factors for bronchopulmonary dysplasia in preterm infants - a multicenter prospective cohort study in China

Acronym

RFBPD-CHN

Study hypothesis

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

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

Study design

Multicenter prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

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 trial start date

01/01/2020

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Preterm infants admitted within 72 hours after birth, gestational age <32 weeks and respiratory distress score ≥5

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

This study will recruit more than 1000 patients

Participant exclusion criteria

Congenital malformations such as complex congenital heart disease, diaphragmatic hernia, anomalies of digestive tract/kidney, and genetic metabolic disorders

Recruitment start date

01/03/2020

Recruitment end date

28/02/2021

Locations

Countries of recruitment

China

Trial participating centre

The Children’s Hospital, Zhejiang University School of Medicine
No. 3333 Binsheng Road
Hangzhou
310052
China

Trial participating centre

Children’s Hospital of Chongqing Medical University
No. 136 Zhongshan 2 Road
Chongqing
400014
China

Trial participating centre

Women's Hospital School Of Medicine Zhejiang University
No. 1 Xueshi Road
Hangzhou
310006
China

Trial participating centre

Shanghai children‘s hospital, Shanghai Jiao Tong University School of Medicine
No. 355 Luding Road
Shanghai
200062
China

Trial participating centre

The Affiliated Obstetrics and Gynecology Hospital of Nanjing Medical University
No. 123 Tianfei lane, Mochou Road
Nanjing
210011
China

Trial participating centre

Ningbo Women and Children's hospital
No. 339 Liuding Road
Ningbo
315012
China

Trial participating centre

Shenzhen Maternity & Child Healthcare Hospital
No. 2004 Hongli Road
Shenzhen
518028
China

Trial participating centre

First Hospital of Jilin University
No. 71 Xinmin Street
Changchun
130021
China

Trial participating centre

Bethune International Peace Hospital of PLA
No. 398 Zhongshan West Road
Shijiazhuang
050082
China

Trial participating centre

5th Medical Center of Chinese PLA General of Hospita
No. 100 West 4th Ring Middle Road
Beijing
100039
China

Trial participating centre

The First Hospital of Tsinghua University
No. 6 Yijiefang Jiuxianqiao
Beijing
100016
China

Trial participating centre

Peking University Third hospital
No. 49 Huayuan North Road
Beijing
100191
China

Trial participating centre

Quanzhou Women's and Children's Hospital
No. 700 Fengze Street
Quzhou
362000
China

Trial participating centre

Chongqing Health Center for Women and Children
No. 120 Longshan Road, Yubei District
Chongqing
401147
China

Trial participating centre

Chengdu Women's & Children's Central Hospital
No. 1617 Riyue Avenue
Chengdu
610074
China

Trial participating centre

Guizhou Maternity and Child Health Care Hospital
No. 63 Ruijin South Road
Guiyang
550003
China

Trial participating centre

The First Affiliated Hospital of Guangxi Medical University
No. 6 Shuangyong Road
Nanning
530021
China

Trial participating centre

The Second Affiliated Hospital of Guangxi Medical University
No. 166 Daxuedong Road
Nanning
530007
China

Trial participating centre

The Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region
No. 59 Xaingzhu Avenue
Nanning
530002
China

Trial participating centre

First Affiliated Hospital of Kunming Medical University
No. 295 Xichang Road
Kunming
650032
China

Trial participating centre

The Second Affiliated Hospital of Kunming Medical University
No. 374 Dianmian Avenue
Kunming
650101
China

Trial participating centre

Kunming Children's Hospital
No. 288 Qianxing Road
Kunming
650228
China

Trial participating centre

The First Affiliated Hospital of Zhengzhou University
No. 1 Jianshe East Road
Zhengzhou
450052
China

Trial participating centre

Henan Children's Hospital
No. 33 Longhu Waihuan East Road
Zhengzhou
450018
China

Trial participating centre

Henan Provincial People's Hospital
No.7 Weiwu Road
Zhengzhou
450003
China

Trial participating centre

Shaanxi Provincial People's Hospital
No. 256 Youyi West Road
Xian
710068
China

Trial participating centre

The First Affiliated Hospital of Xinjiang Medical University
No. 137 Liyushan South Road
Urumqi
830054
China

Trial participating centre

The People's Hospital of Xinjiang Uygur Autonomous Region
No. 91 Tianchi Road
Urumqi
830001
China

Trial participating centre

Qinghai Provincial Women & Children's hospital
No. 15 Gonghe South Road
Xining
810007
China

Trial participating centre

Inner Mongolia People's Hospital
No. 20 Zhaowuda Road
Hohhot
010017
China

Trial participating centre

Gansu Provincial Maternity and Child-care Hospital
No.143 Qilihe North Street
Lanzhou
730050
China

Trial participating centre

Xuzhou Children's Hospital
No. 18 Sudi North Road
Xuzhou
221002
China

Trial participating centre

Yulin Maternity & Child Healthcare Hospital
No. 290 Qingning Road
Yulin
537000
China

Trial participating centre

Chinese Traditional Medicine Affiliated Hospital of Southwest Medical University
No. 182 Chunhui Road
Luzhou
646600
China

Trial participating centre

Qujing Maternity & Child Healthcare Hospital
No. 371 Liaokuo South Road
Qujing
655000
China

Trial participating centre

Taian Maternal and Child Health Hospital
No. 386 Longtai Road
Taian
271000
China

Trial participating centre

The Second Affiliated Hospital of Ningxia Medical University
No. 2 Liqun South Street
Yinchuan
750001
China

Trial participating centre

Mianyang Central Hospital
No. 12 Changjia Lane, Jingzhong Street
Mianyang
621000
China

Trial participating centre

Chongqing Three Gorges Central Hospital
No. 165 Xincheng Road
Chongqing
404000
China

Sponsor information

Organisation

Children's Hospital of Zhejiang University

Sponsor details

3333 Binsheng Road
Hangzhou
310052
China
+86 (0)571 86670083
chenz@zju.edu.cn

Sponsor type

Hospital/treatment centre

Website

http://www.zjuch.cn

Funders

Funder type

Hospital/treatment centre

Funder name

China National Clinical Research Center for Child Health/ China National Children’s Regional Medical Center

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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.

Intention to publish date

31/12/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.