Comparison of CPAP and NIPPV as a Mode of Non-invasive Respiratory Support for Neonates in a Level III NICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Non invasive respiratory support failure
研究概览
简要总结
The objective of the study is to compare the effectiveness of treatment with Non Invasive Positive Pressure Ventilation (NIPPV) and continuous positive airway pressure (CPAP) in decreasing the requirement for endotracheal ventilation in neonates with respiratory distress within the first hours of birth.Primary outcome is the non invasive respiratory support failure and the need for intubated ventilatory support during the first 72 hours of life.
Randomized control , single center trial. Eighty neonates admitted to Neonatal Intensive Care Unit (NICU) were randomly allocated to NIPPV and CPAP. Outcomes of respiratory support were observed and information on risk factors were obtained by going through bed head ticket.
详细描述
Objective of the study:
To compare the effectiveness of CPAP and NIPPV in neonates with mild to moderate respiratory distress.
Specific objectives To determine the effectiveness of CPAP and NIPPV in neonates with mild to moderate respiratory distress To describe neonatal factors associated with CPAP and NIPPV support. To compare the length of hospital stay in neonates who received CPAP and NIPPV To compare the time taken to achieve full enteral nutrition in neonates who received CPAP and NIPPV.
Study design:
Randomized controlled trial
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
盲法说明
Due to type of intervention masking was not possible.
入排标准
- 年龄范围
- 20 Minutes 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All neonates with mild to moderate respiratory distress, requiring non invasive respiratory support on admission as defined by one or more of the following
- •Respiratory distress needing 3L of O2 to maintain saturation of >90%
- •Silverman Anderson score of 4 - 6
- •>2 apnoeic attacks needing tactile stimulation for recovery.
- •One apnoea needs resuscitation
排除标准
- •Major congenital anomalies
- •Presence of cardiovascular instability {sepsis, anemia or severe intraventricular haemorrhage (IVH)}.
- •Intubation needed on admission to the NICU
- •Consent not provided or refused
- •Major cardiac disease (not including patent ductus arteriosus [PDA]),
结局指标
主要结局
Non invasive respiratory support failure
时间窗: 72 hours
Failure of non invasive respiratory support by requirement for endotracheal ventilation with in 72 hours of starting treatment.
次要结局
- duration of respiratory support(21 days)
- time taken to achieve full enteral nutrition(21 days)
- length of hospital stay(28 days)
- Grade III and IV Intra Ventricular Haemorrhage (IVH)(14 days)
研究者
Dr. Anne kaushalya Shilani Gomez,MBBS,MD
acting consultant neonatologist
Ministry of Health, Sri Lanka