Analysis of BPD in Premature Infants With Typical Imaging Changes

NCT ID: NCT04163822

Last Updated: 2023-04-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Total Enrollment

256 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-05-20

Brief Summary

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

Bronchopulmonary dysplasia (BPD) is a common chronic respiratory disease in preterm infants. The increase in the survival rate of premature babies following the improvement of perinatal treatment and care has caused an increase in the incidence of BPD in recent years, which has seriously affected the quality of life of preterm infants. According to the consensus reached at the workshop sponsored by the National Institute of Child Health and Human Development (NICHD) in 2001, BPD was clinically defined based on oxygen dependency in preterm infants. However, the refined NICHD definition of BPD in 2018 emphasizes imaging findings to support a diagnosis of lung parenchyma disease.

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.

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

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

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

Intervention Type OTHER

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

Intervention Type OTHER

no intervention, only observation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no intervention

no intervention, only observation

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

inclusion criteria: (1) BPD diagnosis according to the 2001 NICHD consensus; (2) chest imaging examination (CXR or CT) in the first week after birth; and (3) hospitalization within the first 7 days after birth.

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.
Maximum Eligible Age

2 Years

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, M.D

Role: STUDY_DIRECTOR

Children's Hospital of Chongqing Medical University

Locations

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

Department of Neonatology,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.

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.

Reference Type BACKGROUND
PMID: 30636380 (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)

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)

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.

Reference Type BACKGROUND
PMID: 28506211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19955834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26551413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19190528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24445836 (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)

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.

Reference Type DERIVED
PMID: 34497783 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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

00020190209

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MRI in BPD Subjects
NCT03657693 RECRUITING
Stem Cells for Bronchopulmonary Dysplasia
NCT03378063 WITHDRAWN EARLY_PHASE1
The Baby Lung Study
NCT05152316 COMPLETED
Duodenal Feeds in Very Low Birth Weight Infants
NCT04246333 ACTIVE_NOT_RECRUITING NA