CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 256 enrolled
Drug / intervention
no interventionother
Likely dose
Not stated in record
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Search/NCT04163822
NCT04163822N/ACompleted

Clinical Characteristics and Outcome Analysis of Bronchopulmonary Dysplasia in Premature Infants With Typical Imaging Changes

Wang Jianhui·observational·Posted Nov 15, 2019·Updated Apr 4, 2023

In Brief

An observational study evaluating no intervention for Bronchopulmonary Dysplasia. Completed, enrolled 256 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 15, 2019
Enrollment StartJan 1, 2020
Primary CompletionApr 30, 2021
Study CompletionMay 20, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.6 years ago

Interventions

no interventionother

no intervention, only observation