Analysis of BPD in Premature Infants With Typical Imaging Changes

April 1, 2023 updated by: Wang Jianhui

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Department of Neonatology,Children's Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 9036 preterm infants with GA <36 weeks were admitted to the Department of Neonatology, CHCMU, from January 1, 2014, to December 31, 2018. Among them, 399 (4.4%) infants were diagnosed with BPD. Then, infants who were hospitalized after 7 days of life with missing data and lost to follow-up were excluded. Ultimately, 256 preterm infants were enrolled; 78 (30.5%) had typical chest imaging findings, whereas 178 (69.5%) did not have typical imaging findings. After PSM, the matched groups consisted of 58 pairs of patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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
Other: no intervention
no intervention, only observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: between 28 days after birth and 2 years of age
the number of death/total number（%）
between 28 days after birth and 2 years of age
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
36 wk PMA(infants with GA>32w) or>28 d but <56 d(infants with GA>32w) or discharge to home, whichever comes first
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
at discharge, an average of 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Hospital Stay
Time Frame: at discharge, an average of 2 months
days between admission and first discharge
at discharge, an average of 2 months
Routine Physical Assessment
Time Frame: 2 Years of Age
the measure of infant's length and weight: Underweight/Stunting Stunting was defined as >2 standard deviations (SD) below the mean length for age, and underweight was defined as >2 SD below the mean weight for age. Weight and length were calculated with Chinese growth reference standards
2 Years of Age
Days of Oxygen Supplement
Time Frame: at discharge, an average of 46-56 days
days during which the infants were given oxygen supplement
at discharge, an average of 46-56 days
Wheezing Disorders
Time Frame: between discharge and follow-up, an average of 22 months
Wheezing disorders were defined as a physician diagnosis of wheezing exposure treated with anti-asthma drugs (bronchodilators and corticosteroids)
between discharge and follow-up, an average of 22 months
Clinical Visits and Rehospitalizations
Time Frame: between discharge and follow-up until 2 years of age, an average of 22 months
clinical visits and rehospitalizations for a respiratory reason
between discharge and follow-up until 2 years of age, an average of 22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wang Jianhui

Investigators

  • Study Director: Yuan Shi, M.D, Children's Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

May 20, 2021

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 1, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00020190209

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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