Exogenous Surfactant in Very Preterm Neonates Presenting With Severe Respiratory Distress in Prevention of Bronchopulmonary Dysplasia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 12
- 主要终点
- duration of assisted ventilation
研究概览
简要总结
Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of BPD are not always effective, or related to major side effects. The physiopathological factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the use of an exogenous surfactant in neonates presenting with pulmonary disease requiring mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation and thus promote pulmonary healing and growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Days 至 16 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any neonate of gestational age less than 33 weeks of amenorrhea still on conventional assisted ventilation or HFOV (High Frequency Oscillatory Ventilation), after 14 ± 2 days of life
排除标准
- •active infection (CRP > 30 mg/L) not controlled by appropriate antibiotic treatment
- •use of corticosteroids in the postnatal period
- •significant neurological or malformative disease
- •surgical intervention < 72 hours
- •refusal of parental approval
研究组 & 干预措施
Surfactant instillation
2.5 ml/kg of Surfactant will be instilled in the trachea
干预措施: Curosurf (Drug)
Placebo instillation
2.5 ml/kg of Air will be instilled in the trachea
干预措施: Air (Other)
结局指标
主要结局
duration of assisted ventilation
时间窗: days
we aim to demonstrate a significant reduction in the duration of assisted ventilation in children presenting with severe respiratory distress at 14+/-2 days of life.
次要结局
- to improve height development, psychomotor development and respiratory function(7 years of age)
- to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation(2 years of age)
- to reduce the incidence of BPD(36 weeks post conceptional age)
- to improve the inflammatory status of the lung and to restore its capacities for healing and growth(one month)
研究者
Jean Michel Hascoet
Professor
Maternite Regionale Universitaire