NCT04163822

Analysis of BPD in Premature Infants With Typical Imaging Changes

Completed Results posted Last updated 4 April 2023

What this trial tests

trial testing no intervention in Bronchopulmonary Dysplasia in 256 participants. Completed in 20 May 2021.

Timeline

1 January 2020

Primary endpoint
30 April 2021

20 May 2021

Quick facts

Lead sponsor	Wang Jianhui
Status	Completed
Study type	OBSERVATIONAL
Enrollment	256
Start date	1 January 2020
Primary completion	30 April 2021
Estimated completion	20 May 2021
Sites	1 location across China

Drugs / interventions tested

• no intervention

Conditions studied

• Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →

Sponsor

Wang Jianhui

Who can join

Under 2, any sex, with Bronchopulmonary Dysplasia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mortality Primary · between 28 days after birth and 2 years of age

the number of death/total number（%）

Group	Value	95% CI
Typical Imaging Findings (+)	17
Typical Imaging Findings (-)	7

Number of Participants According to the Severity of BPD Primary · 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

Group	Value	95% CI
Typical Imaging Findings (+)	19
Typical Imaging Findings (-)	7
Typical Imaging Findings (+)	39
Typical Imaging Findings (-)	51

Number of Participants Who Need HOT at Discharge Primary · at discharge, an average of 2 months

need of home oxygen therapy (HOT) at discharge

Group	Value	95% CI
Typical Imaging Findings (+)	43
Typical Imaging Findings (-)	27

Duration of Hospital Stay Secondary · at discharge, an average of 2 months

days between admission and first discharge

Group	Value	95% CI
Typical Imaging Findings (+)	59	33.8 – 68.2
Typical Imaging Findings (-)	56.5	45.2 – 65.0

Routine Physical Assessment Secondary · 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

Group	Value	95% CI
Typical Imaging Findings (+)	3
Typical Imaging Findings (-)	4
Typical Imaging Findings (+)	4
Typical Imaging Findings (-)	7
Typical Imaging Findings (+)	34
Typical Imaging Findings (-)	40

Days of Oxygen Supplement Secondary · at discharge, an average of 46-56 days

days during which the infants were given oxygen supplement

Group	Value	95% CI
Typical Imaging Findings (+)	56	32.7 – 68.2
Typical Imaging Findings (-)	46	38 – 56.2

Wheezing Disorders Secondary · 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)

Group	Value	95% CI
Typical Imaging Findings (+)	5
Typical Imaging Findings (-)	3

Clinical Visits and Rehospitalizations Secondary · between discharge and follow-up until 2 years of age, an average of 22 months

clinical visits and rehospitalizations for a respiratory reason

Group	Value	95% CI
Typical Imaging Findings (+)	20
Typical Imaging Findings (-)	33
Typical Imaging Findings (+)	11
Typical Imaging Findings (-)	10
Typical Imaging Findings (+)	10
Typical Imaging Findings (-)	8

Adverse events — posted to ClinicalTrials.gov

Time frame: Admission date, 2 years. Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Typical Imaging Findings (+)

Serious: 19/58 (33%)

Deaths: 17/58

Typical Imaging Findings (-)

Serious: 7/58 (12%)

Deaths: 7/58

Serious adverse events (1 terms)

Reaction	System	Typical Imaging Findings (+)	Typical Imaging Findings (-)
severe bpd	General disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Typical Imaging Findings (+)	Typical Imaging Findings (-)
leucomalacia	General disorders	—	—

Most-reported serious reactions: severe bpd.

Data from ClinicalTrials.gov NCT04163822 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Characteristics and Outcomes Until 2 Years of Age in Preterm Infants With Typical Chest Imaging Findings of Bronchopulmonary Dysplasia: A Propensity Score Analysis.
   Ruan Q, Wang J, Shi Y. · · 2021 · cited 3× · PMID 34497783 · DOI 10.3389/fped.2021.712516