Clinical Characteristics and Outcome Analysis of Bronchopulmonary Dysplasia in Premature Infants With Typical Imaging Changes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 256
- Locations
- 1
- Primary Endpoint
- Mortality
Study Overview
Brief 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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- — to 2 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mortality
Time Frame: between 28 days after birth and 2 years of age
the number of death/total number（%）
Number of Participants Who Need HOT at Discharge
Time Frame: at discharge, an average of 2 months
need of home oxygen therapy (HOT) at discharge
Number of Participants According to the Severity of BPD
Time Frame: 36 wk PMA(infants with GA>32w) or>28 d but <56 d(infants with GA>32w) or discharge to home, whichever comes first
Mild BPD: Breathing room air Moderate BPD: Need\* for \< 30% oxygen Severe BPD: Need\* for ≥ 30% oxygen and/or positive pressure
Secondary Outcomes
- Routine Physical Assessment(2 Years of Age)
- Days of Oxygen Supplement(at discharge, an average of 46-56 days)
- Duration of Hospital Stay(at discharge, an average of 2 months)
- Wheezing Disorders(between discharge and follow-up, an average of 22 months)
- Clinical Visits and Rehospitalizations(between discharge and follow-up until 2 years of age, an average of 22 months)
Investigators
Wang Jianhui
Attending doctor
Children's Hospital of Chongqing Medical University