Epidemiological Study for Bronchopulmonary Dysplasia (BPD) in China

September 8, 2021 updated by: Children's Hospital of Fudan University

The Incidence, Risk Factors, Diagnosis, Treatments and Burden of Bronchopulmonary Dysplasia (BPD) Among Very Preterm Infants in China: A Nationwide Prospective Cohort Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

3800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All neonates of gestational age less than 32 weeks

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bronchopulmonary dysplasia
Time Frame: 36 weeks of postmenstrual age
Diagnosis by the standard criteria developed by NICHD in 2016 and 2000.
36 weeks of postmenstrual age
Mortality in NICU
Time Frame: through study completion, an average of 3 months
The preterm infants who dies owing to persistent parenchymal lung disease or other diseases in NICUs.
through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NICU length of stay (LOS)
Time Frame: through study completion, an average of 3 months
The length of stay in NICU (days)
through study completion, an average of 3 months
Hospital costs
Time Frame: through study completion, an average of 3 months
The total costs in NICU (yuan)
through study completion, an average of 3 months
Other complications
Time Frame: through study completion, an average of 1 year
Such as NRDS, ROP, NEC, PDA, IVH, pneumothorax, pulmonary hypertension, pneumonia, apnea, hyperbilirubinemia, sepsis, anemia, CNS infection, and so on. All the complications will be diagnosed by the standard criteria made by China Neonatal Network.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Collaborators

The First Affiliated Hospital with Nanjing Medical University
The Affiliated Hospital of Qingdao University
The First Affiliated Hospital of Zhengzhou University
Shanghai Children's Medical Center
Beijing Children's Hospital
First Affiliated Hospital of Xinjiang Medical University
Nanjing Maternity and Child Health Care Hospital
Hunan Children's Hospital
Yantai Yuhuangding Hospital
Shanxi Provincial Maternity and Children's Hospital
Qilu Children's Hospital of Shandong University
Gansu Provincial Maternity and Child-Care Hospital
QuanZhou Women and Children's Hospital
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Ningbo Women & Children's Hospital
Anhui Provincial Children's Hospital
Children's Hospital of Zhengzhou University
Foshan Maternity and Child Health Care Hospital
Shengjing Hospital, China Medical University
Inner Mongolia Maternity and Child Health Care Hospital
Shanghai First Maternity And Infant Hospital, Tongji University
The First Affiliated Hospital of USTC
Yuying Children's Hospital of Wenzhou Medical College
Xiamen Maternity and Child Health Care Hospital
Hubei Maternity and Child Health Care Hospital
Maoming Maternity and Child Health Care Hospital
The Maternity and Child Health Care Hospital of Guangxi Zhuang Autonomous Region
Xinjiang People's Hospital
Chengdu Women and Children's Medical Center
Guizhou Maternity and Child Health Care Hospital
The Affiliated Hospital of Zunyi Medical College

Investigators

  • Study Chair: Chao Chen, MD,PhD, Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (ACTUAL)

February 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKYYBPDMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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