Risk Factors, Clinical Course, Treatment and Prognosis of Neonatal Acute Respiratory Distress Syndrome (ARDS): A Prospective, Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- bronchopulmonary dysplasia(BPD)
研究概览
简要总结
Neonatal acute respiratory distress syndrome(ARDS) is a rare but often severe respiratory disorder. The incidence remains unclear and mortality is about 30%-60%. It is characterized by acute, refractory hypoxemia, persistent respiratory distress and decreased lung compliance. Evaluation and comparison of various clinical studies conducted were hindered by a lack of uniformity in diagnostic criteria.
详细描述
In 2017, the neonatal acute respiratory distress syndrome(ARDS) Consortium Working Group has proposed diagnostic criteria for neonatal ARDS. The study consists of a prospective, multicentre, web-based,cohort study in China in which neonates who fulfil the new criteria definition are enrolled in order to: describe the epidemiology, clinical course, and prognosis of neonates affected by neonatal ARDS; identify a list of risk factors for neonatal ARDS, as it exists for adults and older children with ARDS; and guide future studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute onset (ie, within one week) from a known or suspected clinical insult
- •Exclusion criteria: RDS, TTN, or congenital anomalies as a primary current acute respiratory condition
- •Diffuse, bilateral, and irregular opacities or infiltrates, or complete opacification of the lungs, which are not fully explained by local effusions, atelectasis, RDS, TTN, or congenital anomalies
- •Absence of congenital heart disease explaining the oedema (this includes ductus arteriosus with pulmonary overflow if no acute pulmonary haemorrhage exists). Echocardiography is needed to verify the origin of oedema.
- •Mild ARDS: 4≤OI<8;Moderate ARDS: 8≤OI<16;Severe ARDS: OI≥16
排除标准
- •Hyaline Membrane Disease defined as:
- •Mandatory criteria : defined as respiratory distress syndrome appearing within the first 24 hours of life, with response to surfactant and / or volume recruitment. Additional criteria : Lung imaging Supporting the diagnosis and / or lamellar body counts < 30,000 / mm
- •Transient tachypnea of the neonate (wet lung) defined as:
- •Mandatory criteria : defined as mild ( Silverman score ≤3 ) respiratory distress appearing within the first 24 hours of life and ending within the first 48 hours of life, needing only oxygen administration and / or CPAP. Additional criteria : Lung imaging Supporting the diagnosis and / or lamellar body counts > 30,000 / mm
- •Patients beyond the first month of life
结局指标
主要结局
bronchopulmonary dysplasia(BPD)
时间窗: before discharge or 36 weeks' gestational age
the incidence of BPD in infants with neonatal ARDS
次要结局
- risk factors for ARDS(before discharge or 36 weeks' gestational age)
- death(before discharge or 36 weeks' gestational age)
- epidemiological characteristics in infants with neonatal ARDS(before discharge or 36 weeks' gestational age)
- intraventricular hemorrhage（IVH）(before discharge or 36 weeks' gestational age)
- retinopathy of prematurity(ROP)(before discharge or 36 weeks' gestational age)
- bronchopulmonary dysplasia(BPD) and/or death(before discharge or 36 weeks' gestational age)
- sepsis(before discharge or 36 weeks' gestational age)
- necrotizing enterocolitis(NEC)(before discharge or 36 weeks' gestational age)
研究者
Ma Juan
Principal Investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University