Clinic Features and Outcome of BPD (SGBPD)

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04237844
• Other study ID #: 20191112
• Status: Enrolling by invitation
• Start date: December 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2021
• Source: Children's Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Locations

Country	Name	City	State
China	Children's hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Wang Jianhui

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Steinhorn R, Davis JM, Göpel 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. — View Citation

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. Epub 2007 Dec 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Different subtype of BPD infants against the total BPD infants in corresponding group	up to 12 months after birth
Primary	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
Primary	Duration of first hospital stay	days between admission and first discharge	up to 12 months after birth
Primary	Days with oxygen supplement	days during which the infants were given oxygen	up to 12 months after birth
Primary	Days of Mechanical Ventilation	days during which the infants were given mechanical ventilation	up to 12 months after birth
Secondary	weight	the measure of infant's length	up to 18months after birth
Secondary	length	the measure of infant's weight	up to 18months after birth
Secondary	head circumference	the measure of infant's head circumference, which is the occipital-frontal circumference	up to 18months after birth