Clinic Features and Outcome of BPD (SGBPD)

Clinic Features and Long-term Outcome of Different Subgroups of Brochopulmonary Dysplasia in Preterm Infants

This study described the perinatal high-risk factors and clinical manifestations of the children, and compared the high-risk factors, clinical manifestations and prognosis of BPD among different clinical subtypes by comparison between groups. BPD grading was performed using the 2018 grading standard to compare the distribution of I/II/III BPD among different groups.

Study Overview

• Status: Enrolling by invitation
• Conditions: Bronchopulmonary Dysplasia

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Children's Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Premature infants born at <32 weeks of gestational age and the hospitalization time ≥ 14 days.

Description

Inclusion Criteria:

1. Premature infants born at <32 weeks of gestational age;
2. hospitalization time ≥ 14 days;
3. The clinical medical records are complete

Exclusion Criteria:

• • 1) Children with congenital heart, lung malformation and definite chromosomal diseases; 2) children gave up treatment halfway; 3) corrected gestational age 36 weeks before death, the cause of death was confirmed as factors other than respiratory system.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
no BPD; In preterm infants(GA<32 weeks and hospital day>14 days )，infants without BPD
classic BPD; In preterm infants(GA<32 weeks and hospital day>14 days )，There are clinical manifestations and imaging evidence of RDS after birth, the condition is not relieved, FiO2 lasts >25%
BPD after RDS; In preterm infants(GA<32 weeks and hospital day>14 days )，There are clinical manifestations and imaging evidence of RDS after birth. FiO2<23% within 7 days, and the condition is aggravated to FiO2>25%.
Delayed BPD; In preterm infants(GA<32 weeks and hospital day>14 days )，There is no RDS performance after birth, FiO2 lasts <25%
Early, lethal BPD; In preterm infants(GA<32 weeks and hospital day>14 days )，Some infants who die before 36 weeks PMA (between 14 days of postnatal age and 36 weeks) due to persistent parenchymal lung disease and respiratory failure that can not be attributable to other neonatalmorbidities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Different subtype of BPD infants against the total BPD infants in corresponding group	up to 12 months after birth
Serious respiratory mobidities	occurence of at least one of the following: tracheostomy, continued hospitalization for respiratory reasons at or beyond 50weeks PMA; continued oxygen supplement or respiratory support beyond 12months after birth; readmission for respiratory reasons.	up to 18 months after birth
Duration of first hospital stay	days between admission and first discharge	up to 12 months after birth
Days with oxygen supplement	days during which the infants were given oxygen	up to 12 months after birth
Days of Mechanical Ventilation	days during which the infants were given mechanical ventilation	up to 12 months after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	the measure of infant's length	up to 18months after birth
length	the measure of infant's weight	up to 18months after birth
head circumference	the measure of infant's head circumference, which is the occipital-frontal circumference	up to 18months after birth

Collaborators and Investigators

• Sponsor: Wang Jianhui
• Investigators: Study Director: Yuan Shi, children's hospital of chongqiong Medical University

Publications and helpful links

General Publications

• Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.
• 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.
• 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.
• Shennan AT, Dunn MS, Ohlsson A, Lennox K, Hoskins EM. Abnormal pulmonary outcomes in premature infants: prediction from oxygen requirement in the neonatal period. Pediatrics. 1988 Oct;82(4):527-32.
• Laughon M, Allred EN, Bose C, O'Shea TM, Van Marter LJ, Ehrenkranz RA, Leviton A; ELGAN Study Investigators. Patterns of respiratory disease during the first 2 postnatal weeks in extremely premature infants. Pediatrics. 2009 Apr;123(4):1124-31. doi: 10.1542/peds.2008-0862.
• Streubel AH, Donohue PK, Aucott SW. The epidemiology of atypical chronic lung disease in extremely low birth weight infants. J Perinatol. 2008 Feb;28(2):141-8. doi: 10.1038/sj.jp.7211894. Epub 2007 Dec 6.
• Panickar J, Scholefield H, Kumar Y, Pilling DW, Subhedar NV. Atypical chronic lung disease in preterm infants. J Perinat Med. 2004;32(2):162-7. doi: 10.1515/JPM.2004.029.
• Poindexter BB, Feng R, Schmidt B, Aschner JL, Ballard RA, Hamvas A, Reynolds AM, Shaw PA, Jobe AH; Prematurity and Respiratory Outcomes Program. Comparisons and Limitations of Current Definitions of Bronchopulmonary Dysplasia for the Prematurity and Respiratory Outcomes Program. Ann Am Thorac Soc. 2015 Dec;12(12):1822-30. doi: 10.1513/AnnalsATS.201504-218OC.
• Schmidt B. No End to Uncertainty about Inhaled Glucocorticoids in Preterm Infants. N Engl J Med. 2015 Oct 15;373(16):1566-7. doi: 10.1056/NEJMe1509243. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ACTUAL): October 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (ACTUAL): January 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia
• Other Study ID Numbers: 20191112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No