NCT00556738已完成不适用
Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial
University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes
研究概览
简要总结
During caesarean section, transient respiratory distress which occurs frequently (3%) with possible complications are at present managed by non invasive nasal continuous positive airway pressure ventilation (nCPAP) associated with oxygen therapy. Intrapulmonary Percussive Ventilation (IPV) is a non-invasive ventilatory mode used in some intensive care units to treat some respiratory distress syndrome of the newborn with a good tolerance, but without evaluation in prospective studies
详细描述
- Principal Objective: To show that IPV ventilation can decrease the duration of transient respiratory distress as well as the risk of complications.
- Secondary Objective: Comparison between the two groups regarding: Length of oxygen therapy, complications (pneumothorax, pulmonary infections), need for intensive care hospitalization
- Study design: Open, prospective randomized trial.
- Inclusion criteria: Neonates with gestational age ≥ 35 weeks and weight ≥ 2000g, caesarean section, respiratory distress syndrome (modified Silverman score > 5, SpO2 < 90%), management within 20 minutes after birth.
- Exclusion criteria: clinical thoracic retraction, congenital lung malformation, meconium aspiration, neonatal infection, other congenital malformations.
- Study plan: After the screening evaluation and written consent document, neonates will be randomized into two groups: nCPAP ventilation or IPV. During the 6 hours after randomization, clinical data will be monitored: cardiac and respiratory frequency (CF -RF), saturation (SaO2), oxygenotherapy, Silverman Score. Then, neonates will be supervised 3 days after normalization of the respiratory distress.
- Number of subjects: 100 (50 in each group)
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caesarean newborn
- •Gestational age ≥ 35 weeks
- •Weight ≥ 2 kg
- •SaO2 < 90% after 10 min of life
- •Silverman score ≥ 5
- •Treated less than 20 min after birth
- •Social security affiliation (parents)
- •Informed consent signed (parents)
排除标准
- •Thoracic retraction
- •Congenital intrathoracic malformations
- •Meconium aspiration
- •Early neonatal infections with hemodynamic troubles
- •Severe neonatal asphyxia
- •Polymalformative syndrome
结局指标
主要结局
Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes
时间窗: Within the first 6 hours after birth
次要结局
- Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy(Within the first 72 hours after birth)
研究者
研究点 (2)
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