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临床试验/NCT04184648
NCT04184648
已完成
不适用

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

Wang Jianhui2 个研究点 分布在 1 个国家目标入组 322 人2020年6月1日

概览

阶段
不适用
干预措施
no interventions
疾病 / 适应症
Bronchopulmonary Dysplasia
发起方
Wang Jianhui
入组人数
322
试验地点
2
主要终点
mortality
状态
已完成
最后更新
11天前

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.

注册库
clinicaltrials.gov
开始日期
2020年6月1日
结束日期
2022年7月29日
最后更新
11天前
研究类型
Observational
性别
All

研究者

发起方
Wang Jianhui
责任方
Sponsor Investigator
主要研究者

Wang Jianhui

principal investigator

Children's Hospital of Chongqing Medical University

入排标准

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

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

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)

研究点 (2)

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