Comparison of Classification Standards of BPD in Premature Infants

Study Overview
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Brief Summary
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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.

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

Conditions
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Bronchopulmonary Dysplasia

Intervention / Treatment
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* Other: no interventions


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| There was no adverse systems outcome after PMA36 weeks<br>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 | Other: no interventions<br>* no intervention<br>|
| Death or adverse respiratory outcome after 36 weeks of pma<br>Premature infants at PMA36 weeks presented the following conditions (1) before tracheotomy during follow-up; (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 | Other: no interventions<br>* no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | the proportion of dead BPD infants against the total BPD infants in corresponding group | through study completion, an average of 12 months | 
| serious respiratory mobidities | occurence of at least one of the following:(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. | up to 18 months after birth | 
| Follow-up of neurological development | occurence of at least one of the following:(1) TIMP score ≤ reference P25, or bayley-3 cognitive or motor score < 85; (2) abnormal hearing screening or BAEP for two times; (3) abnormal ROP screening | up to 18 months after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of first hospital stay | days | up to PMA 36 weeks | 
| days of oxygen supplement | days during which the infants were given oxygen supplement | up to 18 months after birth | 
| Pulmonary imaging findings | result of X-ray | up to PMA 36 weeks | 
| Oxygen way | Changes in assisted ventilation | up to 18 months after birth | 
| physical development outcome | including length, weight, head circumference | up to 18 months after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilation mode, premature infant, Bronchopulmonary Dysplasia, high-flow nasal cannula, noninvasive ventilation