Brief Title
Epidemiological Study for Bronchopulmonary Dysplasia (BPD) in China
Official Title
The Incidence, Risk Factors, Diagnosis, Treatments and Burden of Bronchopulmonary Dysplasia (BPD) Among Very Preterm Infants in China: A Nationwide Prospective Cohort Study.
Brief Summary
This study will establish a nationwide cohort of very preterm infants in China, to
investigate the epidemiological characteristics and short-term outcomes of BPD in different
NICUs around the country.
Detailed Description
This is a nationwide multicenter prospective cohort study of very preterm infants in China.
We will collect general information of very preterm infants, maternal and obstetrical
conditions, resuscitation strategies in delivery room, diagnosis of BPD, treatments and
complications from medical record review and family interviews.
This study aims to 1) investigate the epidemiologic characteristics of BPD based on the
National Institutes of Health consensus definition in 2000 and 2016 respectively, and compare
the applicability of two standard criteria for BPD in China; 2) identify independent risk
factors for the development of BPD, such as ethnicity, gender, gestational age, birth weight,
maternal and obstetrical conditions, fetal conditions, chorioamnionitis, infection, anemia,
PDA, early pulmonary hypertension and so on; 3) establish prediction models of BPD at
different postnatal ages; 4) investigate the short-term outcomes of BPD, such as mortality in
NICU, LOS, late pulmonary hypertension, and so on; 5) investigate the prevention and
treatment measures of BPD and evaluate the implementation of high evidence practices to
reduce mortality and BPD, such as using antenatal steroids and caffeine; 6) investigate
economic burden of BPD in China.
This program is organized by the steering committee, on which each clinical center and data
coordinating center are represented. Each center will contribute to data collection and
coordination. The steering committee will hold a conference call every month, meet in-person
twice yearly and additionally hold working meetings at the Congress of Chinese Pediatric
Society and the Congress of Chinese Neonatal Society. The committee will identify and resolve
issues, encourage the centers to finish their work better. The data coordinating center will
manage clinical report forms, provide support for standardization of definitions, data
collection and quality control. The data coordinating center will hold training webinars with
the research team from each site to ensure uniform approaches to data collection before study
inception.
A centralized research electronic data capture system (by Suirong Corporation, Shanghai,
China) will be used in this study. Each site will contribute data using a computer-based
interface. Individual centers will retain access to their own data through customized
downloads from the database management tool.
Data cleaning and statistical analysis will be conducted by an independent epidemiology &
statistics work group from Children's Hospital of Fudan University and Public Health School
of Fudan University. The study protocol and consent forms were evaluated by the institutional
review board (IRB) of Fudan University. The protocol, questionnaire, statistical analysis
plan and IRB approvals will be accessible on the website of China Neonatal Network.
Study Type
Observational
Primary Outcome
Bronchopulmonary dysplasia
Secondary Outcome
NICU length of stay (LOS)
Condition
Bronchopulmonary Dysplasia
Intervention
No intervention
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
3800
Start Date
January 1, 2020
Completion Date
December 2022
Primary Completion Date
June 2022
Eligibility Criteria
Inclusion Criteria:
- Infants with GA less than 32 weeks;
- Admitted to member neonatology centers during the period of recruitment;
- Age at admission less than 28 days.
Exclusion Criteria:
- Infants with major congenital anomalies, which include but not limited to serious
congenital heart defects, chromosomal abnormalities, gastrointestinal atresias, brain
malformations, congenital diaphragmatic hernia, renal agenesis or dysplastic kidneys;
- Infants with inborn errors of metabolism;
- Infants with severe heritable disease.
Gender
All
Ages
N/A - 28 Days
Accepts Healthy Volunteers
No
Contacts
Chao Chen, MD,PhD, 021-64931186, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03850457
Organization ID
EKYYBPDMC
Responsible Party
Sponsor
Study Sponsor
Children's Hospital of Fudan University
Collaborators
Shengjing Hospital, China Medical University
Study Sponsor
Chao Chen, MD,PhD, Study Chair, Children's Hospital of Fudan University
Verification Date
July 2019