Clinical trial NCT04163822: Analysis of BPD in Premature Infants With Typical Imaging Changes
Official title: Clinical Characteristics and Outcome Analysis of Bronchopulmonary Dysplasia in Premature Infants With Typical Imaging Changes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Keywords: bronchopulmonary dysplasia
typical chest imaging findings
clinical characteristics
outcomes
preterm infants
propensity score
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 256
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: between 28 days after birth and 2 years of age
measure: Number of Participants According to the Severity of BPD
timeFrame: 36 wk PMA(infants with GA>32w) or>28 d but <56 d(infants with GA>32w) or discharge to home, whichever comes first
measure: Number of Participants Who Need HOT at Discharge
timeFrame: at discharge, an average of 2 months
Secondary outcomes:
measure: Duration of Hospital Stay
timeFrame: at discharge, an average of 2 months
measure: Routine Physical Assessment
timeFrame: 2 Years of Age
measure: Days of Oxygen Supplement
timeFrame: at discharge, an average of 46-56 days
measure: Wheezing Disorders
timeFrame: between discharge and follow-up, an average of 22 months
measure: Clinical Visits and Rehospitalizations
timeFrame: between discharge and follow-up until 2 years of age, an average of 22 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Neonatology,Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Yuan Shi, M.D
role: STUDY_DIRECTOR
References:
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citation: Ruan Q, Wang J, Shi Y. Clinical Characteristics and Outcomes Until 2 Years of Age in Preterm Infants With Typical Chest Imaging Findings of Bronchopulmonary Dysplasia: A Propensity Score Analysis. Front Pediatr. 2021 Aug 23;9:712516. doi: 10.3389/fped.2021.712516. eCollection 2021.