Clinical trial NCT03850457: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Keywords: bronchopulmonary dysplasia
preterm infants
epidemiologic characteristics
risk factors
mortality
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shengjing Hospital
name: Beijing Children's Hospital
name: Inner Mongolia Maternity and Child Health Care Hospital
name: Shanxi Provincial Maternity and Children's Hospital
name: Qilu Children's Hospital of Shandong University
name: The Affiliated Hospital of Qingdao University
name: Yantai Yuhuangding Hospital
name: Shanghai Children's Medical Center
name: Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
name: The First Affiliated Hospital with Nanjing Medical University
name: Nanjing Maternity and Child Health Care Hospital
name: The First Affiliated Hospital of USTC
name: Anhui Provincial Children's Hospital
name: Yuying Children's Hospital of Wenzhou Medical College
name: Ningbo Women & Children's Hospital
name: QuanZhou Women and Children's Hospital
name: Xiamen Maternity and Child Health Care Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Children's Hospital of Zhengzhou University
name: Hubei Maternity and Child Health Care Hospital
name: Hunan Children's Hospital
name: Foshan Maternity and Child Health Care Hospital
name: Maoming Maternity and Child Health Care Hospital
name: Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
name: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
name: Gansu Provincial Maternal and Child Health Care Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: Xinjiang People's Hospital
name: Chengdu Women and Children's Medical Center
name: Guizhou Maternity and Child Health Care Hospital
name: The Affiliated Hospital of Zunyi Medical College
First posted: 2019-02-21
Enrollment: 3800
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All neonates of gestational age less than 32 weeks

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.

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.

Primary outcomes:
measure: Bronchopulmonary dysplasia
timeFrame: 36 weeks of postmenstrual age
measure: Mortality in NICU
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: NICU length of stay (LOS)
timeFrame: through study completion, an average of 3 months
measure: Hospital costs
timeFrame: through study completion, an average of 3 months
measure: Other complications
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Chao Chen, MD,PhD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1542/peds.2005-0249.
citation: Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.
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. No abstract available.
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. No abstract available.