Analysis of BPD in Premature Infants With Typical Imaging Changes
NCT ID: NCT04163822
Last Updated: 2023-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
256 participants
OBSERVATIONAL
2020-01-01
2021-05-20
Brief Summary
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Fibrotic opacities and cystic changes on chest imaging (chest X-ray \[CXR\] or computed tomography \[CT\] scan) were considered typical findings in BPD patients. In patients with severe BPD, the presence of bubbles/cystic appearance on CXR after 28 days of life was reported to be an important factor, and typical imaging findings can predict a poor pulmonary outcome in BPD patients. BPD is associated with poor outcomes. Although many studies have been conducted on BPD, there are limited reports specifically evaluating the association of typical imaging findings with clinical characteristics and later outcomes in patients with BPD.
We hypothesized that BPD with typical imaging findings was likely to be a particular subgroup of this entity, with a unique etiology, clinical characteristics and prognosis. Therefore, this retrospective study aimed to compare clinical characteristics, short-term outcomes and follow-up data until 2 years of age in preterm infants with or without typical imaging findings of BPD on CXR or CT scan during the entire hospital stay. A propensity score analysis was used to reduce bias between the two groups, and multivariate logistic regression analysis was performed to identify factors related to mortality in preterm infants with BPD.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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group with typical imaging changes
the BPD infants with typical chest imaging findings include fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.
no intervention
no intervention, only observation
group without typical imaging changes
the infants meet the diagnosis criteria of BPD, but lack of typical chest imaging findings
no intervention
no intervention, only observation
Interventions
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no intervention
no intervention, only observation
Eligibility Criteria
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Inclusion Criteria
exclusion criteria: (1) major congenital malformations or laboratory-confirmed chromosomal abnormalities; (2) inadequate clinical data or missing chest imaging data; or (3) loss to follow-up.
2 Years
ALL
No
Sponsors
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Wang Jianhui
OTHER
Responsible Party
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Wang Jianhui
Attending doctor
Principal Investigators
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Yuan Shi, M.D
Role: STUDY_DIRECTOR
Children's Hospital of Chongqing Medical University
Locations
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Department of Neonatology,Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Countries
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References
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Arai H, Ito T, Ito M, Ota S, Takahashi T; Neonatal Research Network of Japan. Impact of chest radiography-based definition of bronchopulmonary dysplasia. Pediatr Int. 2019 Mar;61(3):258-263. doi: 10.1111/ped.13786. Epub 2019 Mar 7.
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.
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.
Kim HR, Kim JY, Yun B, Lee B, Choi CW, Kim BI. Interstitial pneumonia pattern on day 7 chest radiograph predicts bronchopulmonary dysplasia in preterm infants. BMC Pediatr. 2017 May 15;17(1):125. doi: 10.1186/s12887-017-0881-1.
Kim DH, Choi CW, Kim EK, Kim HS, Kim BI, Choi JH, Lee MJ, Yang EG. Association of increased pulmonary interleukin-6 with the priming effect of intra-amniotic lipopolysaccharide on hyperoxic lung injury in a rat model of bronchopulmonary dysplasia. Neonatology. 2010 Jun;98(1):23-32. doi: 10.1159/000263056. Epub 2009 Dec 2.
Choi CW, Lee J, Oh JY, Lee SH, Lee HJ, Kim BI. Protective effect of chorioamnionitis on the development of bronchopulmonary dysplasia triggered by postnatal systemic inflammation in neonatal rats. Pediatr Res. 2016 Feb;79(2):287-94. doi: 10.1038/pr.2015.224. Epub 2015 Nov 9.
Viscardi RM, Hasday JD. Role of Ureaplasma species in neonatal chronic lung disease: epidemiologic and experimental evidence. Pediatr Res. 2009 May;65(5 Pt 2):84R-90R. doi: 10.1203/PDR.0b013e31819dc2f9.
Lowe J, Watkins WJ, Edwards MO, Spiller OB, Jacqz-Aigrain E, Kotecha SJ, Kotecha S. Association between pulmonary ureaplasma colonization and bronchopulmonary dysplasia in preterm infants: updated systematic review and meta-analysis. Pediatr Infect Dis J. 2014 Jul;33(7):697-702. doi: 10.1097/INF.0000000000000239.
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.
Ruan Q, Wang J, Shi Y. Clinical Characteristics and Outcomes Until 2 Years of Age in Preterm Infants With Typical Chest Imaging Findings of Bronchopulmonary Dysplasia: A Propensity Score Analysis. Front Pediatr. 2021 Aug 23;9:712516. doi: 10.3389/fped.2021.712516. eCollection 2021.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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00020190209
Identifier Type: -
Identifier Source: org_study_id
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