The Risk of Intraventricular Hemorrhage With Flat Midline Versus Right-Tilted Flat Lateral Head Positions in Preterm Infant Less Than 30 Weeks of Gestation: a Multicenter Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 71
- 试验地点
- 6
- 主要终点
- All grade IVH incidence
研究概览
简要总结
Intraventricular hemorrhage (IVH) in preterm infants is one of many devastating consequences of prematurity that have both acute and long-term sequelae. Turning a preterm infant's head to one side may increase intracranial pressure and occlude major ipsilateral veins in the neck, which could increase cerebral venous pressure and decrease cerebral venous drainage. Keeping preterm infants' heads in a slightly elevated midline position (side or supine) during the first 168 hours(HOL) has been recommended as one of the 10 potentially better practices to reduce the incidence of IVH in preterm infants. To the best of our knowledge, there has been no systematically collected clinical data quantifying the relationship between IVH and head position in preterm infants. However, the midline head position may challenge the well-known right neonatal head position preference. This preference continues until 3-6 months of age, after which preterm neonates keep their heads mainly in midline. The best head position for preterm neonates is still to be determined. Therefore, the investigators are aiming to conduct a large scale multicenter randomized control trial on order to answer the following research question: Does keeping heads of preterm infants less than 30 weeks of gestation in flat midline (FM) throughout the first 168 HOL reduce the risk of IVH compared to right flat lateral (rFL)? We hypothesized that keeping heads of preterm infants less than 30 weeks of gestation in FM throughout the first 168 HOL would reduce the risk of IVH compared to rFL.
详细描述
Investigators will randomly assign infants lying on flat (zero degree) beds to be cared for either in a supine FM or a supine rFL head position throughout the first 168 HOL. Investigators will mount a sign on the incubator indicating the assigned head position to be maintained during the first 168 HOL. The goal is to keep the neonates' heads in their assigned positions throughout the first 168 HOL unless a medical indication required a change in position. The left flat lateral head position will be the back-up position whenever the medical conditions of the study neonates preclude maintaining the assigned head positions. The bedside nurse will check the correctness of the infants' head positions every 4 hours by using the built-in spirit (bubble) level of the open-bed incubators and an L-shaped ruler. Investigators are going to use an elbow connector of HUDSON RCI circuit (adult circuit) in a case SENSORMEDICS will be required for neonates in FM group. Investigators will watch and record pressure ulcers or technical difficulties arising from using high-frequency ventilation (HFV) in the infants in FM position. After their first 168 HOL, the study infants will be given routine nursing care provided in their NICU, including a change in head position every 6-12 hours or as needed on a slightly elevated bed. For obvious reasons, the medical team will be unmasked to the assigned head position. It will be left for the physician discretion for controversial/diversity issue (s) in neonatal care but it will be recorded.
Timing of HUS examinations
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All study neonates will have two screening head ultrasounds (HUS) as follows:
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Within first 12 HOL.
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At about 168 HOL.
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Otherwise, investigators will carry HUS according to established IVH diagnosis guidelines:
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As early as a clinical suspicion of IVH is raised.
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When IVH is detected, then a follow up HUS is repeated within 5-7 days later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 2 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born at the three study NICUs.
- •Gestational age < 30 weeks.
排除标准
- •Lethal congenital anomalies.
- •Hypoxic ischemic encephalopathy.
- •Need external cardiac compression or epinephrine administration at birth.
结局指标
主要结局
All grade IVH incidence
时间窗: First 168 hours of life.
To compared all grade IVH incidence in a FM head position with that of a rFL head position in preterm infant less than 30 weeks of gestation.
次要结局
- Severity of IVH(First 168 hours of life.)
- Complications(First 168 hours of life.)
- Diagnosis of IVH(First 168 hours of life)
- Subgroup analysis(First 168 hours of life.)
研究者
Dr. Sameer Al-Abdi
Consultant Neonatologist
King Abdul Aziz General Hospital