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NCT Number: NCT04163822

Analysis of BPD 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.

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Key information

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neonatology,Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

no intervention, only observation

Primary outcomes

  1. Mortality

    Time frame: between 28 days after birth and 2 years of age

    the number of death/total number(%)

  2. 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

  3. 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

Secondary outcomes

  1. Duration of Hospital Stay

    Time frame: at discharge, an average of 2 months

    days between admission and first discharge

  2. 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

  3. Days of Oxygen Supplement

    Time frame: at discharge, an average of 46-56 days

    days during which the infants were given oxygen supplement

  4. 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)

  5. 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

Sponsors and collaborators

Lead sponsor

Wang Jianhui

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 15, 2019
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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