Comparison of Classification Standards of Bronchopulmonary Dysplasia (BPD) in Premature Infants (NCT04184648) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Classification Standards of Bronchopulmonary Dysplasia (BPD) in Premature Infants
China322 participantsStarted 2020-06-01
Plain-language 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.
Who can participate
Age range
32 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already been completed, would my baby's doctors be able to share or discuss any findings from this study that might help us better understand how they're classifying or grading the severity of their bronchopulmonary dysplasia?
2This trial was comparing different classification standards for BPD — does it matter which grading system my baby's care team is using, and could different classification methods lead to different treatment decisions?
3The trial tracked 'respiratory adverse outcomes' as its main measure — based on what this study found, are there specific breathing or lung complications we should be watching for most closely in a premature baby diagnosed with BPD?
4Since this was not a treatment trial but a classification study, how does understanding BPD severity categories actually change the care plan, and should we be asking for a second opinion on how my baby's BPD is being graded?
5Are there ongoing treatment trials for BPD that my baby might be eligible for, now that research like this one has helped refine how BPD severity is defined and measured?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.