N/A
N=270
Comparison of Classification Standards of Bronchopulmonary Dysplasia (BPD) in Premature Infants
Bronchopulmonary Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT04184648 ↗Enrolled (actual)
270
Serious AEs
5.9%
Results posted
Apr 2026
Primary outcome: Primary: Respiratory Adverse Outcomes — 27; 60 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- no interventions (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Wang Jianhui
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Adverse Outcomes |
27; 60 | — |
| SECONDARY Growth Restriction |
10; 18 | — |
| SECONDARY Days of Oxygen Supplement |
— | — |
| SECONDARY Physical Development Outcome |
— | — |
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(High Flow Nasal Cannula Oxygen) and other NIV(Non-Invasive Ventilation) 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(National Institute of Child Health and Human Development) 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.
Data sourced from ClinicalTrials.gov (NCT04184648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.