Analysis of BPD in Premature Infants With Typical Imaging Changes

NCT04163822 | Completed Results

• 1 other identifier: 00020190209
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia

Keywords

bronchopulmonary dysplasia; typical chest imaging findings; clinical characteristics; outcomes; preterm infants; propensity score

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Duration of Hospital Stay

  at discharge, an average of 2 months

• Routine Physical Assessment

  2 Years of Age

• Days of Oxygen Supplement

  at discharge, an average of 46-56 days

• Wheezing Disorders

  between discharge and follow-up, an average of 22 months

• Clinical Visits and Rehospitalizations

  between discharge and follow-up until 2 years of age, an average of 22 months

Study Arms (2)

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.

Other: no intervention

group without typical imaging changes

the infants meet the diagnosis criteria of BPD, but lack of typical chest imaging findings

Other: no intervention

Interventions

no intervention OTHER

no intervention, only observation

group with typical imaging changes; group without typical imaging changes

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

Sponsors & Collaborators

• Wang Jianhui: lead

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400014, China

Location

Related Publications (10)

• 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.

  PMID: 30636380 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.

  PMID: 29551318 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.

  PMID: 5334613 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.

  PMID: 28506211 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.

  PMID: 19955834 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.

  PMID: 26551413 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.

  PMID: 19190528 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.

  PMID: 24445836 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.

  PMID: 29173299 BACKGROUND

• 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.

  PMID: 34497783 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

(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.

Results Point of Contact

• Title: no sponsor, PI: Yuan Shi
• Organization: CHCMU

shiyuan@hospital.cqmu.edu.cn

13508320283

Study Officials

• Yuan Shi, M.D

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 15, 2019
• Study Start: January 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 20, 2021
• Last Updated: April 4, 2023
• Results First Posted: April 4, 2023

Record last verified: 2023-04

Locations

CN (1)