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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group with typical imaging changes | the BPD infants with typical chest imaging findings include fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay. |
| |
| group without typical imaging changes | the infants meet the diagnosis criteria of BPD, but lack of typical chest imaging findings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | no intervention, only observation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | the number of death/total number（%） | between 28 days after birth and 2 years of age |
| 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 | 36 wk PMA(infants with GA>32w) or>28 d but <56 d(infants with GA>32w) or discharge to home, whichever comes first |
| Number of Participants Who Need HOT at Discharge | need of home oxygen therapy (HOT) at discharge | at discharge, an average of 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospital Stay | days between admission and first discharge | at discharge, an average of 2 months |
| 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 |
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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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Yuan Shi, M.D | Children's Hospital of Chongqing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neonatology,Children's Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400014 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30636380 | Background | Arai H, Ito T, Ito M, Ota S, Takahashi T; Neonatal Research Network of Japan. Impact of chest radiography-based definition of bronchopulmonary dysplasia. Pediatr Int. 2019 Mar;61(3):258-263. doi: 10.1111/ped.13786. Epub 2019 Mar 7. | |
| 29551318 | Background | Higgins RD, Jobe AH, Koso-Thomas M, Bancalari E, Viscardi RM, Hartert TV, Ryan RM, Kallapur SG, Steinhorn RH, Konduri GG, Davis SD, Thebaud B, Clyman RI, Collaco JM, Martin CR, Woods JC, Finer NN, Raju TNK. Bronchopulmonary Dysplasia: Executive Summary of a Workshop. J Pediatr. 2018 Jun;197:300-308. doi: 10.1016/j.jpeds.2018.01.043. Epub 2018 Mar 16. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Typical Imaging Findings (+) | BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.) |
| FG001 | Typical Imaging Findings (-) | BPD infants without typical chest imaging findings |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Age means Gestational age(months)
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| ID | Title | Description |
|---|---|---|
| BG000 | Typical Imaging Finding (+) | Infants with typical imaging findings |
| BG001 | Typical Imaging Finding (-) | Infants without typical imaging findings |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | the number of death/total number（%） | number of each group after PSM | Posted | Count of Participants | Participants | between 28 days after birth and 2 years of age |
|
Admission date, 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Typical Imaging Findings (+) | BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| severe bpd | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| leucomalacia | General disorders | Non-systematic Assessment |
(1) this is a retrospective study, which inevitably leads to loss of follow-up and clinical data. A standardized follow-up program has not been perfected in our unit, especially 3 years ago or even earlier. (2) This is a single-center study of Chinese premature infants.(3) We used propensity score matching to balance some of the known confounding variables between the groups. However, it is inevitable to pay the cost of missing samples.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| no sponsor, PI: Yuan Shi | CHCMU | 13508320283 | shiyuan@hospital.cqmu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2021 | Dec 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 2 Years of Age |
| Days of Oxygen Supplement | days during which the infants were given oxygen supplement | at discharge, an average of 46-56 days |
| Wheezing Disorders | Wheezing disorders were defined as a physician diagnosis of wheezing exposure treated with anti-asthma drugs (bronchodilators and corticosteroids) | between discharge and follow-up, an average of 22 months |
| Clinical Visits and Rehospitalizations | clinical visits and rehospitalizations for a respiratory reason | between discharge and follow-up until 2 years of age, an average of 22 months |
| 5334613 | Background | Northway WH Jr, Rosan RC, Porter DY. Pulmonary disease following respirator therapy of hyaline-membrane disease. Bronchopulmonary dysplasia. N Engl J Med. 1967 Feb 16;276(7):357-68. doi: 10.1056/NEJM196702162760701. No abstract available. |
| 28506211 | Background | Kim HR, Kim JY, Yun B, Lee B, Choi CW, Kim BI. Interstitial pneumonia pattern on day 7 chest radiograph predicts bronchopulmonary dysplasia in preterm infants. BMC Pediatr. 2017 May 15;17(1):125. doi: 10.1186/s12887-017-0881-1. |
| 19955834 | Background | Kim DH, Choi CW, Kim EK, Kim HS, Kim BI, Choi JH, Lee MJ, Yang EG. Association of increased pulmonary interleukin-6 with the priming effect of intra-amniotic lipopolysaccharide on hyperoxic lung injury in a rat model of bronchopulmonary dysplasia. Neonatology. 2010 Jun;98(1):23-32. doi: 10.1159/000263056. Epub 2009 Dec 2. |
| 26551413 | Background | Choi CW, Lee J, Oh JY, Lee SH, Lee HJ, Kim BI. Protective effect of chorioamnionitis on the development of bronchopulmonary dysplasia triggered by postnatal systemic inflammation in neonatal rats. Pediatr Res. 2016 Feb;79(2):287-94. doi: 10.1038/pr.2015.224. Epub 2015 Nov 9. |
| 19190528 | Background | Viscardi RM, Hasday JD. Role of Ureaplasma species in neonatal chronic lung disease: epidemiologic and experimental evidence. Pediatr Res. 2009 May;65(5 Pt 2):84R-90R. doi: 10.1203/PDR.0b013e31819dc2f9. |
| 24445836 | Background | Lowe J, Watkins WJ, Edwards MO, Spiller OB, Jacqz-Aigrain E, Kotecha SJ, Kotecha S. Association between pulmonary ureaplasma colonization and bronchopulmonary dysplasia in preterm infants: updated systematic review and meta-analysis. Pediatr Infect Dis J. 2014 Jul;33(7):697-702. doi: 10.1097/INF.0000000000000239. |
| 29173299 | Background | Steinhorn R, Davis JM, Gopel W, Jobe A, Abman S, Laughon M, Bancalari E, Aschner J, Ballard R, Greenough A, Storari L, Thomson M, Ariagno RL, Fabbri L, Turner MA; International Neonatal Consortium. Chronic Pulmonary Insufficiency of Prematurity: Developing Optimal Endpoints for Drug Development. J Pediatr. 2017 Dec;191:15-21.e1. doi: 10.1016/j.jpeds.2017.08.006. No abstract available. |
| 34497783 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| 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 | After psm,each group has 58 infants | Posted | Count of Participants | Participants | 36 wk PMA(infants with GA>32w) or>28 d but <56 d(infants with GA>32w) or discharge to home, whichever comes first |
|
|
|
| Primary | Number of Participants Who Need HOT at Discharge | need of home oxygen therapy (HOT) at discharge | each group has 58 infants after PSM | Posted | Count of Participants | Participants | at discharge, an average of 2 months |
|
|
|
| Secondary | Duration of Hospital Stay | days between admission and first discharge | each group has 58 infants after PSM | Posted | Median | Inter-Quartile Range | days | at discharge, an average of 2 months |
|
|
|
| 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 | each group has 58 infants after PSM; 17 and 7 infants died in each group before they reached 2 years old. | Posted | Count of Participants | Participants | 2 Years of Age |
|
|
|
| Secondary | Days of Oxygen Supplement | days during which the infants were given oxygen supplement | each group has 58 infants after PSM | Posted | Number | 95% Confidence Interval | days | at discharge, an average of 46-56 days |
|
|
|
| Secondary | Wheezing Disorders | Wheezing disorders were defined as a physician diagnosis of wheezing exposure treated with anti-asthma drugs (bronchodilators and corticosteroids) | each group has 58 infants after PSM; 17 and 7 infants died in each group during the follow-up | Posted | Count of Participants | Participants | between discharge and follow-up, an average of 22 months |
|
|
|
| Secondary | Clinical Visits and Rehospitalizations | clinical visits and rehospitalizations for a respiratory reason | each group has 58 infants after PSM; 17 infants and 7 infants died in each group during follow-up | Posted | Count of Participants | Participants | between discharge and follow-up until 2 years of age, an average of 22 months |
|
|
|
| 17 |
| 58 |
| 19 |
| 58 |
| 4 |
| 78 |
| EG001 | Typical Imaging Findings (-) | BPD infants without typical chest imaging findings | 7 | 58 | 7 | 58 | 6 | 178 |
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| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| children without underweight and stunting |
|
| Clinical visits >10 times |
|