SUCTIONING AT BIRTH WITH BULB SYRINGE OR SUCTION CATHETER: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Oxygen saturation during the first 10 minutes of life
研究概览
简要总结
This study is designed to compare two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants at birth.
详细描述
Objective of the study: This trial aims to compare two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants needing suctioning at birth.
Primary outcome measure: Oxygen saturation during the first 10 minutes of life.
Study design: This is a single center, prospective, randomized clinical trial comparing two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants needing suctioning at birth.
Setting: The study is conducted at the St. Luke Catholic Hospital in Wolisso (Ethiopia), which is a level III hospital with around 3,600 deliveries per year.
Immediately after birth, all infants needing suctioning are randomized to receive suctioning with bulb syringe or suction catheter. All resuscitative procedures are performed following the Helping Babies Breathe algorithm. An external observer, not involved in the care of the newborn, is responsible of the positioning the probe of the pulse oximeter and the collection of the data.
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
Masking is not possible due to the study design. Only statistician who will perform the analysis will be blind to the arm allocation.
入排标准
- 年龄范围
- 1 Minute 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •inborn infants (and)
- •need for suctioning at birth (and)
- •parental consent
排除标准
- •Major congenital malformations
- •Parental refusal to participate in the study
结局指标
主要结局
Oxygen saturation during the first 10 minutes of life
时间窗: 10 minutes
Preductal oxygen saturation will be measured by a pulse-oxymeter during the first 10 minutes of life
次要结局
- Heart rate during the first 10 minutes of life(10 minutes)
- Neonates with saturation >80% at 5 minutes(5 minutes)
- Admission to the special care unit(30 minutes)
- Episodes of bradycardia in the first 10 minutes of life(10 minutes)
- Supplemental oxygen in delivery room(30 minutes)
- Neonates with heart rate >100 beats per minute at 5 minutes(5 minutes)
- Face-mask ventilation(10 minutes)
- Respiratory distress during the first 48 hours of life(48 hours)
- Time for achieving transcutaneous saturations >90%(30 minutes)
- Local lesions(10 minutes)
研究者
Daniele Trevisanuto
Associate Professor
University Hospital Padova