Clinic Features and Outcome of BPD (SGBPD)

• Conditions: Bronchopulmonary Dysplasia

• Registration Number: NCT04237844
• Lead Sponsor: Wang Jianhui

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2020-01-21
• Study First Posted: 2020-01-23
• Study Start: 2020-12-01
• Primary Completion: 2021-10-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-11-23
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	up to 12 months after birth	Different subtype of BPD infants against the total BPD infants in corresponding group
Duration of first hospital stay	up to 12 months after birth	days between admission and first discharge
Days with oxygen supplement	up to 12 months after birth	days during which the infants were given oxygen
Days of Mechanical Ventilation	up to 12 months after birth	days during which the infants were given mechanical ventilation
Serious respiratory mobidities	up to 18 months after birth	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.

Secondary Outcome Measures

Name	Time	Method
head circumference	up to 18months after birth	the measure of infant's head circumference, which is the occipital-frontal circumference
weight	up to 18months after birth	the measure of infant's length
length	up to 18months after birth	the measure of infant's weight

Trial Locations

Locations (1)

Children's hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China