Skip to content

Comparison of Classification Standards of Bronchopulmonary Dysplasia (BPD) in Premature Infants

Clinical Study on Comparative Diagnostic Criteria of Bronchopulmonary Dysplasia in Premature Infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04184648
Enrollment
322
Registered
2019-12-03
Start date
2020-06-01
Completion date
2022-07-29
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary Dysplasia, high-flow nasal cannula, noninvasive ventilation, Ventilation mode, premature infant

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(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.

Interventions

OTHERno interventions

no intervention

Sponsors

Wang Jianhui
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Respiratory Adverse Outcomesup to 18 months after birthRespiratory adverse outcomes include all types of neonatal lung diseases

Secondary

MeasureTime frameDescription
Growth Restrictionup to PMA 18-24 monthsheight, weight or head circumference \<3rd percentile for corrected gestational age and sex, growth percentiles defined using the World Health Organization Child Growth Standards
Days of Oxygen Supplementup to 18 months after birthdays during which the infants were given oxygen supplement
Physical Development Outcomeup to 18 months after birthincluding length, weight, head circumference

Countries

China

Contacts

STUDY_DIRECTORYuan Shi, M.D

Children's Hospital of Chongqing Medical University

Participant flow

Pre-assignment details

Infants with severe congenital malformations or missing key study data were excluded

Baseline characteristics

Characteristic
Age, Customized
Gestational age
29.7 weeks
STANDARD_DEVIATION 1.4
Birth weight1459.5 grams
STANDARD_DEVIATION 277
Cesarean section73 Participants
Prenatal glucocorticosteroids administration88 Participants
Race/Ethnicity, Customized
Chinese Han populations
270 Participants
Sex: Female, Male
Female
58 Participants
Sex: Female, Male
Male
84 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
5 / 13014 / 140
other
Total, other adverse events
3 / 1307 / 140
serious
Total, serious adverse events
5 / 13011 / 140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026