Bronchopulmonary DysplasiaNCT04237844
Clinic Features and Outcome of BPD (SGBPD)
An observational study of Bronchopulmonary Dysplasia, run by Wang Jianhui at 1 site in China.
Trial summary
This study described the perinatal high-risk factors and clinical manifestations of the children, and compared the high-risk factors, clinical manifestations and prognosis of BPD among different clinical subtypes by comparison between groups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchopulmonary Dysplasia
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Premature infants born at <32 weeks of gestational age and the hospitalization time ≥ 14 days.
Who may be able to join
- Premature infants born at <32 weeks of gestational age;
- hospitalization time ≥ 14 days;
- The clinical medical records are complete
Who cannot join
- • 1) Children with congenital heart, lung malformation and definite chromosomal diseases; 2) children gave up treatment halfway; 3) corrected gestational age 36 weeks before death, the cause of death was confirmed as factors other than respiratory system.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
About this study
Official title: Clinic Features and Long-term Outcome of Different Subgroups of Brochopulmonary Dysplasia in Preterm Infants
This study described the perinatal high-risk factors and clinical manifestations of the children, and compared the high-risk factors, clinical manifestations and prognosis of BPD among different clinical subtypes by comparison between groups. BPD grading was performed using the 2018 grading standard to compare the distribution of I/II/III BPD among different groups.
- Conditions
- Bronchopulmonary Dysplasia
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no BPD | In preterm infants(GA<32 weeks and hospital day>14 days )，infants without BPD | |
| classic BPD | In preterm infants(GA<32 weeks and hospital day>14 days )，There are clinical manifestations and imaging evidence of RDS after birth, the condition is not relieved, FiO2 lasts >25% | |
| BPD after RDS | In preterm infants(GA<32 weeks and hospital day>14 days )，There are clinical manifestations and imaging evidence of RDS after birth. FiO2<23% within 7 days, and the condition is aggravated to FiO2>25%. | |
| Delayed BPD | In preterm infants(GA<32 weeks and hospital day>14 days )，There is no RDS performance after birth, FiO2 lasts <25% | |
| Early, lethal BPD | In preterm infants(GA<32 weeks and hospital day>14 days )，Some infants who die before 36 weeks PMA (between 14 days of postnatal age and 36 weeks) due to persistent parenchymal lung disease and respiratory failure that can not be attributable to other neonatalmorbidities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Different subtype of BPD infants against the total BPD infants in corresponding group
Measured: up to 12 months after birth
Serious respiratory mobidities
occurence of at least one of the following: tracheostomy, continued hospitalization for respiratory reasons at or beyond 50weeks PMA; continued oxygen supplement or respiratory support beyond 12months after birth; readmission for respiratory reasons.
Measured: up to 18 months after birth
Duration of first hospital stay
days between admission and first discharge
Measured: up to 12 months after birth
Days with oxygen supplement
days during which the infants were given oxygen
Measured: up to 12 months after birth
Days of Mechanical Ventilation
days during which the infants were given mechanical ventilation
Measured: up to 12 months after birth
Secondary outcomes (3)
weight
the measure of infant's length
Measured: up to 18months after birth
length
the measure of infant's weight
Measured: up to 18months after birth
head circumference
the measure of infant's head circumference, which is the occipital-frontal circumference
Measured: up to 18months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Dec 2020
- Primary completion30 Oct 2021
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Jianhui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Jianhui, Children's Hospital of Chongqing Medical University
- Investigators
- Yuan Shi, Study director, children's hospital of chongqiong Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237844
- Sponsor's protocol ID
- 20191112
- Status last verified
- Nov 2021
- First submitted
- 18 Dec 2019
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Northway WH Jr, Rosan RC, Porter DY. Pulmonary disease following respirator therapy of hyaline-membrane disease. Bronchopulmonary dysplasia. N Engl J Med. 1967 Feb 16;276(7):357-68. doi: 10.1056/NEJM196702162760701. No abstract available.
PubMed 5334613Shennan AT, Dunn MS, Ohlsson A, Lennox K, Hoskins EM. Abnormal pulmonary outcomes in premature infants: prediction from oxygen requirement in the neonatal period. Pediatrics. 1988 Oct;82(4):527-32.
PubMed 3174313Jobe 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 11401896Laughon M, Allred EN, Bose C, O'Shea TM, Van Marter LJ, Ehrenkranz RA, Leviton A; ELGAN Study Investigators. Patterns of respiratory disease during the first 2 postnatal weeks in extremely premature infants. Pediatrics. 2009 Apr;123(4):1124-31. doi: 10.1542/peds.2008-0862.
PubMed 19336371Streubel AH, Donohue PK, Aucott SW. The epidemiology of atypical chronic lung disease in extremely low birth weight infants. J Perinatol. 2008 Feb;28(2):141-8. doi: 10.1038/sj.jp.7211894. Epub 2007 Dec 6.
PubMed 18059466Panickar J, Scholefield H, Kumar Y, Pilling DW, Subhedar NV. Atypical chronic lung disease in preterm infants. J Perinat Med. 2004;32(2):162-7. doi: 10.1515/JPM.2004.029.
PubMed 15085893Poindexter BB, Feng R, Schmidt B, Aschner JL, Ballard RA, Hamvas A, Reynolds AM, Shaw PA, Jobe AH; Prematurity and Respiratory Outcomes Program. Comparisons and Limitations of Current Definitions of Bronchopulmonary Dysplasia for the Prematurity and Respiratory Outcomes Program. Ann Am Thorac Soc. 2015 Dec;12(12):1822-30. doi: 10.1513/AnnalsATS.201504-218OC.
PubMed 26397992Schmidt B. No End to Uncertainty about Inhaled Glucocorticoids in Preterm Infants. N Engl J Med. 2015 Oct 15;373(16):1566-7. doi: 10.1056/NEJMe1509243. No abstract available.
PubMed 26465990Higgins 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 29551318Steinhorn R, Davis JM, Gopel W, Jobe A, Abman S, Laughon M, Bancalari E, Aschner J, Ballard R, Greenough A, Storari L, Thomson M, Ariagno RL, Fabbri L, Turner MA; International Neonatal Consortium. Chronic Pulmonary Insufficiency of Prematurity: Developing Optimal Endpoints for Drug Development. J Pediatr. 2017 Dec;191:15-21.e1. doi: 10.1016/j.jpeds.2017.08.006. No abstract available.
PubMed 29173299
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic Features and Long-term Outcome of Different Subgroups of Brochopulmonary Dysplasia in Preterm Infants
- ClinicalTrials.gov ID
- NCT04237844
- Acronym / sponsor ID
- 20191112
- Conditions
- Bronchopulmonary Dysplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wang JianhuiUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 23 Jan 2020 (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 described the perinatal high-risk factors and clinical manifestations of the children, and compared the high-risk factors, clinical manifestations and prognosis of BPD among different clinical subtypes by comparison between groups. BPD grading was performed using the 2018 grading standard to compare the distribution of I/II/III BPD among different groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| no BPD | – | –In preterm infants(GA<32 weeks and hospital day>14 days )，infants without BPD |
| classic BPD | – | –In preterm infants(GA<32 weeks and hospital day>14 days )，There are clinical manifestations and imaging evidence of RDS after birth, the condition is not relieved, FiO2 lasts >25% |
| BPD after RDS | – | –In preterm infants(GA<32 weeks and hospital day>14 days )，There are clinical manifestations and imaging evidence of RDS after birth. FiO2<23% within 7 days, and the condition is aggravated to FiO2>25%. |
| Delayed BPD | – | –In preterm infants(GA<32 weeks and hospital day>14 days )，There is no RDS performance after birth, FiO2 lasts <25% |
| Early, lethal BPD | – | –In preterm infants(GA<32 weeks and hospital day>14 days )，Some infants who die before 36 weeks PMA (between 14 days of postnatal age and 36 weeks) due to persistent parenchymal lung disease and respiratory failure that can not be attributable to other neonatalmorbidities |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Premature infants born at <32 weeks of gestational age and the hospitalization time ≥ 14 days.
Key inclusion criteria (3 listed)
- Premature infants born at <32 weeks of gestational age;
- hospitalization time ≥ 14 days;
- The clinical medical records are complete
Key exclusion criteria (1 listed)
- • 1) Children with congenital heart, lung malformation and definite chromosomal diseases; 2) children gave up treatment halfway; 3) corrected gestational age 36 weeks before death, the cause of death was confirmed as factors other than respiratory system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: up to 12 months after birth
Different subtype of BPD infants against the total BPD infants in corresponding group
Serious respiratory mobidities
Time frame: up to 18 months after birth
occurence of at least one of the following: tracheostomy, continued hospitalization for respiratory reasons at or beyond 50weeks PMA; continued oxygen supplement or respiratory support beyond 12months after birth; readmission for respiratory reasons.
Duration of first hospital stay
Time frame: up to 12 months after birth
days between admission and first discharge
Days with oxygen supplement
Time frame: up to 12 months after birth
days during which the infants were given oxygen
Days of Mechanical Ventilation
Time frame: up to 12 months after birth
days during which the infants were given mechanical ventilation
3 secondary outcomes
weight
Time frame: up to 18months after birth
length
Time frame: up to 18months after birth
head circumference
Time frame: up to 18months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Background: PubMed 5334613Northway WH Jr, Rosan RC, Porter DY. Pulmonary disease following respirator therapy of hyaline-membrane disease. Bronchopulmonary dysplasia. N Engl J Med. 1967 Feb 16;276(7):357-68. doi: 10.1056/NEJM196702162760701. No abstract available.
- Background: PubMed 3174313Shennan AT, Dunn MS, Ohlsson A, Lennox K, Hoskins EM. Abnormal pulmonary outcomes in premature infants: prediction from oxygen requirement in the neonatal period. Pediatrics. 1988 Oct;82(4):527-32.
- 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 19336371Laughon M, Allred EN, Bose C, O'Shea TM, Van Marter LJ, Ehrenkranz RA, Leviton A; ELGAN Study Investigators. Patterns of respiratory disease during the first 2 postnatal weeks in extremely premature infants. Pediatrics. 2009 Apr;123(4):1124-31. doi: 10.1542/peds.2008-0862.
- Background: PubMed 18059466Streubel AH, Donohue PK, Aucott SW. The epidemiology of atypical chronic lung disease in extremely low birth weight infants. J Perinatol. 2008 Feb;28(2):141-8. doi: 10.1038/sj.jp.7211894. Epub 2007 Dec 6.
- Background: PubMed 15085893Panickar J, Scholefield H, Kumar Y, Pilling DW, Subhedar NV. Atypical chronic lung disease in preterm infants. J Perinat Med. 2004;32(2):162-7. doi: 10.1515/JPM.2004.029.
- Background: PubMed 26397992Poindexter BB, Feng R, Schmidt B, Aschner JL, Ballard RA, Hamvas A, Reynolds AM, Shaw PA, Jobe AH; Prematurity and Respiratory Outcomes Program. Comparisons and Limitations of Current Definitions of Bronchopulmonary Dysplasia for the Prematurity and Respiratory Outcomes Program. Ann Am Thorac Soc. 2015 Dec;12(12):1822-30. doi: 10.1513/AnnalsATS.201504-218OC.
- Background: PubMed 26465990Schmidt B. No End to Uncertainty about Inhaled Glucocorticoids in Preterm Infants. N Engl J Med. 2015 Oct 15;373(16):1566-7. doi: 10.1056/NEJMe1509243. 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 29173299Steinhorn R, Davis JM, Gopel W, Jobe A, Abman S, Laughon M, Bancalari E, Aschner J, Ballard R, Greenough A, Storari L, Thomson M, Ariagno RL, Fabbri L, Turner MA; International Neonatal Consortium. Chronic Pulmonary Insufficiency of Prematurity: Developing Optimal Endpoints for Drug Development. J Pediatr. 2017 Dec;191:15-21.e1. doi: 10.1016/j.jpeds.2017.08.006. No abstract available.
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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.
Yuan Shi study director
children's hospital of chongqiong Medical 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 Wang Jianhui 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 1 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: status not confirmed, as of the sponsor's last update on 23 Nov 2021. 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?
Results are not available in the source record.
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?
Mortality (time frame: up to 12 months after birth). The study lists 5 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 NCT04237844, which also lists 10 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 23 Nov 2021.