Epidemiological Study for Bronchopulmonary Dysplasia (BPD) in China

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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