Epidemiological Study for Bronchopulmonary Dysplasia (BPD) in China

Bronchopulmonary Dysplasia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03850457
• Other study ID #: EKYYBPDMC
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Children's Hospital of Fudan University
• Contact: Chao Chen, MD,PhD
• Phone: 021-64931186
• Email: chen6010[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3800
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia

Intervention

Other:
• No intervention
The treatments will be determined by their neonatologists and no additional investigational drugs will be applied to the infants included in this study.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (32)

Lead Sponsor

Collaborator

Children's Hospital of Fudan University

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

Country where clinical trial is conducted

China, 

References & Publications (4)

Ehrenkranz RA, Walsh MC, Vohr BR, Jobe AH, Wright LL, Fanaroff AA, Wrage LA, Poole K; National Institutes of Child Health and Human Development Neonatal Research Network. Validation of the National Institutes of Health consensus definition of bronchopulmonary dysplasia. Pediatrics. 2005 Dec;116(6):1353-60. — View Citation

Higgins RD, Jobe AH, Koso-Thomas M, Bancalari E, Viscardi RM, Hartert TV, Ryan RM, Kallapur SG, Steinhorn RH, Konduri GG, Davis SD, Thebaud B, Clyman RI, Collaco JM, Martin CR, Woods JC, Finer NN, Raju TNK. Bronchopulmonary Dysplasia: Executive Summary of a Workshop. J Pediatr. 2018 Jun;197:300-308. doi: 10.1016/j.jpeds.2018.01.043. Epub 2018 Mar 16. — View Citation

Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. — View Citation

Krishnan U, Feinstein JA, Adatia I, Austin ED, Mullen MP, Hopper RK, Hanna B, Romer L, Keller RL, Fineman J, Steinhorn R, Kinsella JP, Ivy DD, Rosenzweig EB, Raj U, Humpl T, Abman SH; Pediatric Pulmonary Hypertension Network (PPHNet). Evaluation and Management of Pulmonary Hypertension in Children with Bronchopulmonary Dysplasia. J Pediatr. 2017 Sep;188:24-34.e1. doi: 10.1016/j.jpeds.2017.05.029. Epub 2017 Jun 20. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchopulmonary dysplasia	Diagnosis by the standard criteria developed by NICHD in 2016 and 2000.	36 weeks of postmenstrual age
Primary	Mortality in NICU	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	NICU length of stay (LOS)	The length of stay in NICU (days)	through study completion, an average of 3 months
Secondary	Hospital costs	The total costs in NICU (yuan)	through study completion, an average of 3 months
Secondary	Other complications	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