Bronchopulmonary Dysplasia
Conditions
Keywords
bronchopulmonary dysplasia, typical chest imaging findings, clinical characteristics, outcomes, preterm infants, propensity score
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.
Interventions
OTHERno intervention
no intervention, only observation
Sponsors
Wang Jianhui
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | between 28 days after birth and 2 years of age | the number of death/total number（%） |
| 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 |
| Number of Participants Who Need HOT at Discharge | at discharge, an average of 2 months | need of home oxygen therapy (HOT) at discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hospital Stay | at discharge, an average of 2 months | days between admission and first discharge |
| 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 |
| 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 |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Typical Imaging Finding (+) Infants with typical imaging findings | 78 |
| Typical Imaging Finding (-) Infants without typical imaging findings | 178 |
| Total | 256 |
Baseline characteristics
| Characteristic | Typical Imaging Finding (-) | Total | Typical Imaging Finding (+) |
|---|---|---|---|
| Age, Continuous | 30.6 months | 30.3 months | 29.4 months |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 178 Participants | 256 Participants | 78 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 70 Participants | 108 Participants | 38 Participants |
| Sex: Female, Male Male | 108 Participants | 148 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 17 / 58 | 7 / 58 |
| other Total, other adverse events | 4 / 78 | 6 / 178 |
| serious Total, serious adverse events | 19 / 58 | 7 / 58 |
Outcome results
Primary
Mortality
the number of death/total number（%）
Time frame: between 28 days after birth and 2 years of age
Population: number of each group after PSM
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Typical Imaging Findings (+) | Mortality | 17 Participants |
| Typical Imaging Findings (-) | Mortality | 7 Participants |
Primary
Number of Participants According to the Severity of BPD
Mild BPD: Breathing room air Moderate BPD: Need\* for \< 30% oxygen Severe BPD: Need\* for ≥ 30% oxygen and/or positive pressure
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
Population: After psm,each group has 58 infants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Typical Imaging Findings (+) | Number of Participants According to the Severity of BPD | mild-moderate BPD | 39 Participants |
| Typical Imaging Findings (+) | Number of Participants According to the Severity of BPD | severe BPD | 19 Participants |
| Typical Imaging Findings (-) | Number of Participants According to the Severity of BPD | severe BPD | 7 Participants |
| Typical Imaging Findings (-) | Number of Participants According to the Severity of BPD | mild-moderate BPD | 51 Participants |
Primary
Number of Participants Who Need HOT at Discharge
need of home oxygen therapy (HOT) at discharge
Time frame: at discharge, an average of 2 months
Population: each group has 58 infants after PSM
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Typical Imaging Findings (+) | Number of Participants Who Need HOT at Discharge | 43 Participants |
| Typical Imaging Findings (-) | Number of Participants Who Need HOT at Discharge | 27 Participants |
Secondary
Clinical Visits and Rehospitalizations
clinical visits and rehospitalizations for a respiratory reason
Time frame: between discharge and follow-up until 2 years of age, an average of 22 months
Population: each group has 58 infants after PSM; 17 infants and 7 infants died in each group during follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Typical Imaging Findings (+) | Clinical Visits and Rehospitalizations | Clinical visits <5 times | 20 Participants |
| Typical Imaging Findings (+) | Clinical Visits and Rehospitalizations | Clinical visits 5-10 times | 11 Participants |
| Typical Imaging Findings (+) | Clinical Visits and Rehospitalizations | Clinical visits >10 times | 10 Participants |
| Typical Imaging Findings (-) | Clinical Visits and Rehospitalizations | Clinical visits <5 times | 33 Participants |
| Typical Imaging Findings (-) | Clinical Visits and Rehospitalizations | Clinical visits 5-10 times | 10 Participants |
| Typical Imaging Findings (-) | Clinical Visits and Rehospitalizations | Clinical visits >10 times | 8 Participants |
Secondary
Days of Oxygen Supplement
days during which the infants were given oxygen supplement
Time frame: at discharge, an average of 46-56 days
Population: each group has 58 infants after PSM
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Typical Imaging Findings (+) | Days of Oxygen Supplement | 56 days |
| Typical Imaging Findings (-) | Days of Oxygen Supplement | 46 days |
Secondary
Duration of Hospital Stay
days between admission and first discharge
Time frame: at discharge, an average of 2 months
Population: each group has 58 infants after PSM
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Typical Imaging Findings (+) | Duration of Hospital Stay | 59 days |
| Typical Imaging Findings (-) | Duration of Hospital Stay | 56.5 days |
Secondary
Routine Physical Assessment
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
Time frame: 2 Years of Age
Population: each group has 58 infants after PSM; 17 and 7 infants died in each group before they reached 2 years old.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Typical Imaging Findings (+) | Routine Physical Assessment | Underweight | 3 Participants |
| Typical Imaging Findings (+) | Routine Physical Assessment | Stunting | 4 Participants |
| Typical Imaging Findings (+) | Routine Physical Assessment | children without underweight and stunting | 34 Participants |
| Typical Imaging Findings (-) | Routine Physical Assessment | Underweight | 4 Participants |
| Typical Imaging Findings (-) | Routine Physical Assessment | Stunting | 7 Participants |
| Typical Imaging Findings (-) | Routine Physical Assessment | children without underweight and stunting | 40 Participants |
Secondary
Wheezing Disorders
Wheezing disorders were defined as a physician diagnosis of wheezing exposure treated with anti-asthma drugs (bronchodilators and corticosteroids)
Time frame: between discharge and follow-up, an average of 22 months
Population: each group has 58 infants after PSM; 17 and 7 infants died in each group during the follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Typical Imaging Findings (+) | Wheezing Disorders | 5 Participants |
| Typical Imaging Findings (-) | Wheezing Disorders | 3 Participants |