Bronchopulmonary DysplasiaNCT03850457
Epidemiological Study for Bronchopulmonary Dysplasia (BPD) in China
An observational study of Bronchopulmonary Dysplasia, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Bronchopulmonary Dysplasia
- How many people
- 3,800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: All neonates of gestational age less than 32 weeks
Who may be able to join
- Infants with GA less than 32 weeks;
- Admitted to member neonatology centers during the period of recruitment;
- Age at admission less than 28 days.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
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.
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.
Read the 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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- No intervention
- Keywords
- bronchopulmonary dysplasia, preterm infants, epidemiologic characteristics, risk factors, mortality
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
The treatments will be determined by their neonatologists and no additional investigational drugs will be applied to the infants included in this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchopulmonary dysplasia
Diagnosis by the standard criteria developed by NICHD in 2016 and 2000.
Measured: 36 weeks of postmenstrual age
Mortality in NICU
The preterm infants who dies owing to persistent parenchymal lung disease or other diseases in NICUs.
Measured: through study completion, an average of 3 months
Secondary outcomes (3)
NICU length of stay (LOS)
The length of stay in NICU (days)
Measured: through study completion, an average of 3 months
Hospital costs
The total costs in NICU (yuan)
Measured: through study completion, an average of 3 months
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Jan 2020
- Primary completion30 Nov 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shengjing Hospital, Beijing Children's Hospital, Inner Mongolia Maternal and Child Health Care Hospital, Shanxi Provincial Maternity and Children's Hospital, Qilu Children's Hospital of Shandong University, The Affiliated Hospital of Qingdao University, Yantai Yuhuangding Hospital, Shanghai Children's Medical Center, Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School, The First Affiliated Hospital with Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital, The First Affiliated Hospital of University of Science and Technology of China, Anhui Provincial Children's Hospital, Yuying Children's Hospital of Wenzhou Medical University, Ningbo Women & Children's Hospital, QuanZhou Women and Children's Hospital, Xiamen Maternity and Child Health Care Hospital, The First Affiliated Hospital of Zhengzhou University, Zhengzhou Children's Hospital, China, Hubei Maternity and Child Health Care Hospital, Hunan Children's Hospital, Foshan Maternity and Child Health Care Hospital, Maoming Maternity and Child Health Care Hospital, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Gansu Provincial Maternal and Child Health Care Hospital, First Affiliated Hospital of Xinjiang Medical University, Xinjiang People's Hospital, Chengdu Women and Children's Center Hospital, Guizhou Maternity and Child Health Care Hospital, The Affiliated Hospital of Zunyi Medical College
- Responsible party
- Sponsor
- Investigators
- Chao Chen, MD,PhD, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850457
- Sponsor's protocol ID
- EKYYBPDMC
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2019
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16322158Jobe 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.
PubMed 11401896Higgins 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.
PubMed 29551318Krishnan 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.
PubMed 28645441Dai Y, Sheng K, Hu L. Diagnostic efficacy of targeted high-throughput sequencing for lower respiratory infection in preterm infants. Am J Transl Res. 2022 Nov 15;14(11):8204-8214. eCollection 2022.
PubMed 36505277
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03850457
- Acronym / sponsor ID
- EKYYBPDMC
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- bronchopulmonary dysplasia, preterm infants, epidemiologic characteristics, risk factors, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,800 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shengjing Hospital, Beijing Children's Hospital, Inner Mongolia Maternal and Child Health Care Hospital, Shanxi Provincial Maternity and Children's Hospital, Qilu Children's Hospital of Shandong University, The Affiliated Hospital of Qingdao University, Yantai Yuhuangding Hospital, Shanghai Children's Medical Center, Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School, The First Affiliated Hospital with Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital, The First Affiliated Hospital of University of Science and Technology of China, Anhui Provincial Children's Hospital, Yuying Children's Hospital of Wenzhou Medical University, Ningbo Women & Children's Hospital, QuanZhou Women and Children's Hospital, Xiamen Maternity and Child Health Care Hospital, The First Affiliated Hospital of Zhengzhou University, Zhengzhou Children's Hospital, China, Hubei Maternity and Child Health Care Hospital, Hunan Children's Hospital, Foshan Maternity and Child Health Care Hospital, Maoming Maternity and Child Health Care Hospital, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Gansu Provincial Maternal and Child Health Care Hospital, First Affiliated Hospital of Xinjiang Medical University, Xinjiang People's Hospital, Chengdu Women and Children's Center Hospital, Guizhou Maternity and Child Health Care Hospital, The Affiliated Hospital of Zunyi Medical College
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All neonates of gestational age less than 32 weeks
Key inclusion criteria (3 listed)
- Infants with GA less than 32 weeks;
- Admitted to member neonatology centers during the period of recruitment;
- Age at admission less than 28 days.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThe treatments will be determined by their neonatologists and no additional investigational drugs will be applied to the infants included in this study. | Other | – |
Primary outcome
Bronchopulmonary dysplasia
Time frame: 36 weeks of postmenstrual age
Diagnosis by the standard criteria developed by NICHD in 2016 and 2000.
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.
3 secondary outcomes
NICU length of stay (LOS)
Time frame: through study completion, an average of 3 months
Hospital costs
Time frame: through study completion, an average of 3 months
Other complications
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 16322158Ehrenkranz 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.
- Background: PubMed 11401896Jobe 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.
- Background: PubMed 29551318Higgins 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.
- Background: PubMed 28645441Krishnan 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.
- Derived from this study: PubMed 36505277Dai Y, Sheng K, Hu L. Diagnostic efficacy of targeted high-throughput sequencing for lower respiratory infection in preterm infants. Am J Transl Res. 2022 Nov 15;14(11):8204-8214. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao Chen, MD,PhD study chair
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchopulmonary dysplasia (time frame: 36 weeks of postmenstrual age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03850457, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.