Comparison of Classification Standards of BPD in Premature Infants

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Other: no interventions

• Registration Number: NCT04184648
• Lead Sponsor: Wang Jianhui

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-29
• Study First Submitted QC: 2019-11-29
• Study First Posted: 2019-12-03
• Study Start: 2020-06-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-17
• Primary Completion: 2022-06-20
• Study Completion: 2022-06-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Death or adverse respiratory outcome after 36 weeks of pma	no interventions	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
There was no adverse systems outcome after PMA36 weeks	no interventions	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

Primary Outcome Measures

Name	Time	Method
mortality	through study completion, an average of 12 months	the proportion of dead BPD infants against the total BPD infants in corresponding group
serious respiratory mobidities	up to 18 months after birth	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.
Follow-up of neurological development	up to 18 months after birth	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China