Clinic Features and Outcome of BPD (SGBPD)

NCT04237844 | Unknown DMC

• 1 other identifier: 20191112
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• weight

  up to 18months after birth

• length

  up to 18months after birth

• head circumference

  up to 18months after birth

Study Arms (5)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Premature infants born at \<32 weeks of gestational age;
• hospitalization time ≥ 14 days;
• The clinical medical records are complete

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wang Jianhui: lead

Study Sites (1)

Children's hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

Location

Related Publications (10)

• 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

• 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.

  PMID: 3174313 BACKGROUND

• 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.

  PMID: 11401896 BACKGROUND

• 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.

  PMID: 19336371 BACKGROUND

• 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.

  PMID: 18059466 BACKGROUND

• 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.

  PMID: 15085893 BACKGROUND

• 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.

  PMID: 26397992 BACKGROUND

• 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.

  PMID: 26465990 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

• 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

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

Study Officials

• Yuan Shi

  children's hospital of chongqiong Medical University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: January 23, 2020
• Study Start: December 1, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

CN (1)