Analysis of BPD in Premature Infants With Typical Imaging Changes

Completed

Conditions: Bronchopulmonary Dysplasia

Interventions: Other: no intervention

Registration Number: NCT04163822

Lead Sponsor: Wang Jianhui

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 256

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group without typical imaging changes	no intervention	the infants meet the diagnosis criteria of BPD, but lack of typical chest imaging findings
group with typical imaging changes	no intervention	the BPD infants with typical chest imaging findings include fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.

Primary Outcome Measures

Name	Time	Method
Mortality	between 28 days after birth and 2 years of age	the number of death/total number（%）
Number of Participants Who Need HOT at Discharge	at discharge, an average of 2 months	need of home oxygen therapy (HOT) at discharge
Number of Participants According to the Severity of BPD	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 Outcome Measures

Name	Time	Method
Routine Physical Assessment	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
Days of Oxygen Supplement	at discharge, an average of 46-56 days	days during which the infants were given oxygen supplement
Duration of Hospital Stay	at discharge, an average of 2 months	days between admission and first discharge
Wheezing Disorders	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)
Clinical Visits and Rehospitalizations	between discharge and follow-up until 2 years of age, an average of 22 months	clinical visits and rehospitalizations for a respiratory reason