Brief Title
Comparison of Classification Standards of BPD in Premature Infants
Official Title
Clinical Study on Comparative Diagnostic Criteria of Bronchopulmonary Dysplasia in Premature Infants
Brief Summary
Bronchopulmonary dysplasia of premature infants is a common respiratory disease in premature infants. Long-term complications such as recurrent respiratory infection and abnormal lung function may occur in the survivors, and may increase the risk of dysplasia of the nervous system. In the past 30 years, although the monitoring and treatment technology of premature infants has been significantly improved, the incidence of BPD still shows no downward trend, and effective treatment and prevention methods for BPD are still lacking. The progress of clinical research on BPD is slow, one of the important reasons is that the definition of BPD is still not consistent, and its diagnostic and grading standards lack objectivity. To summarize the development of diagnostic criteria for BPD in the past 30 years, there are still the following disadvantages. 1. 2. In the above study, all proposed alternative BPD classification standards did not completely separate HFNC and NIV. In view of this, this study separated HFNC and other NIV to form a new revised BPD classification standard. On this basis, a nested case-control study was conducted to compare the differences between the newly proposed classification standards and NICHD standards in 2001, Rosemary standards in 2018 and Jensen standards in predicting long-term respiratory outcomes and other systemic complications in premature infants, so as to provide a standard for more accurate diagnosis and evaluation of BPD in premature infants.
Study Type
Observational
Primary Outcome
mortality
Secondary Outcome
Length of first hospital stay
Condition
Bronchopulmonary Dysplasia
Intervention
no interventions
Study Arms / Comparison Groups
There was no adverse systems outcome after PMA36 weeks
Description: Premature infants at PMA36 weeks did not show the following conditions (1) before follow-up tracheotomy; (2) the duration of hospital stay exceeds 50 weeks of PMA; (3) continuous or intermittent use of oxygen and respiratory support for more than 12 months after birth; (4) readmission ≥2 times due to respiratory factors within 12 months. (5) death
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
200
Start Date
June 1, 2020
Completion Date
June 29, 2022
Primary Completion Date
June 20, 2022
Eligibility Criteria
Inclusion Criteria: - premature infants whose gestational age is less than 32 weeks; - hospital stay ≥14 days; - complete clinical medical records, including effective follow-up information Exclusion Criteria: - congenital heart and lung malformation and specific chromosomal diseases; - children abandon treatment halfway; - death of children due to factors other than respiratory system.
Gender
All
Ages
N/A - 32 Weeks
Accepts Healthy Volunteers
No
Contacts
Yuan Shi, M.D, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04184648
Organization ID
00020191112
Responsible Party
Sponsor-Investigator
Study Sponsor
Wang Jianhui
Study Sponsor
Yuan Shi, M.D, Study Director, Children's Hospital of Chongqing Medical University
Verification Date
November 2020