Clinical trial NCT04184648: Comparison of Classification Standards of BPD in Premature Infants
Official title: Clinical Study on Comparative Diagnostic Criteria of Bronchopulmonary Dysplasia in Premature Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary Dysplasia
high-flow nasal cannula
noninvasive ventilation
Ventilation mode
premature infant
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 200
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All premature infants whose gestational age is less than 32 weeks admitted to the neonatal department of children's hospital of chongqing medical university from January 2018 to May 2019 were in line with this study.

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.


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.

Primary outcomes:
measure: mortality
timeFrame: through study completion, an average of 12 months
measure: serious respiratory mobidities
timeFrame: up to 18 months after birth
measure: Follow-up of neurological development
timeFrame: up to 18 months after birth
Secondary outcomes:
measure: Length of first hospital stay
timeFrame: up to PMA 36 weeks
measure: days of oxygen supplement
timeFrame: up to 18 months after birth
measure: Pulmonary imaging findings
timeFrame: up to PMA 36 weeks
measure: Oxygen way
timeFrame: up to 18 months after birth
measure: physical development outcome
timeFrame: up to 18 months after birth
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Yuan Shi, M.D
role: STUDY_DIRECTOR
References:
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