Clinical Study on Comparative Diagnostic Criteria of Bronchopulmonary Dysplasia in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 322
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •premature infants whose gestational age is less than 32 weeks;
- •hospital stay ≥14 days;
- •complete clinical medical records, including effective follow-up information
排除标准
- •congenital heart and lung malformation and specific chromosomal diseases;
- •children abandon treatment halfway;
- •death of children due to factors other than respiratory system.
研究组 & 干预措施
There was no adverse systems outcome after PMA36 weeks
Premature infants at PMA（postmenstrual age）36 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
干预措施: no interventions (Other)
Death or adverse respiratory outcome after 36 weeks of pma
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
干预措施: no interventions (Other)
结局指标
主要结局
mortality
时间窗: 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
时间窗: 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
时间窗: 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
Respiratory Adverse Outcomes
时间窗: up to 18 months after birth
Respiratory adverse outcomes include all types of neonatal lung diseases
次要结局
- Length of first hospital stay(up to PMA 36 weeks)
- days of oxygen supplement(up to 18 months after birth)
- Oxygen way(up to 18 months after birth)
- Pulmonary imaging findings(up to PMA 36 weeks)
- physical development outcome(up to 18 months after birth)
- Growth Restriction(up to PMA 18-24 months)
- Days of Oxygen Supplement(up to 18 months after birth)
- Physical Development Outcome(up to 18 months after birth)
研究者
Wang Jianhui
principal investigator
Children's Hospital of Chongqing Medical University