Clinic Features and Outcome of BPD (SGBPD)

NCT ID: NCT04237844

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchopulmonary Dysplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

no BPD

In preterm infants(GA\<32 weeks and hospital day\>14 days ),infants without BPD

No interventions assigned to this group

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%

No interventions assigned to this group

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%.

No interventions assigned to this group

Delayed BPD

In preterm infants(GA\<32 weeks and hospital day\>14 days ),There is no RDS performance after birth, FiO2 lasts \<25%

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Premature infants born at \<32 weeks of gestational age;
2. hospitalization time ≥ 14 days;
3. The clinical medical records are complete

Exclusion Criteria

* • 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wang Jianhui

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wang Jianhui

Attending doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yuan Shi

Role: STUDY_DIRECTOR

children's hospital of chongqiong Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 5334613 (View on PubMed)

Shennan 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.

Reference Type BACKGROUND
PMID: 3174313 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11401896 (View on PubMed)

Laughon 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.

Reference Type BACKGROUND
PMID: 19336371 (View on PubMed)

Streubel 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.

Reference Type BACKGROUND
PMID: 18059466 (View on PubMed)

Panickar 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.

Reference Type BACKGROUND
PMID: 15085893 (View on PubMed)

Poindexter 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.

Reference Type BACKGROUND
PMID: 26397992 (View on PubMed)

Schmidt 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.

Reference Type BACKGROUND
PMID: 26465990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29551318 (View on PubMed)

Steinhorn 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.

Reference Type BACKGROUND
PMID: 29173299 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20191112

Identifier Type: -

Identifier Source: org_study_id