The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- 72 hours preterm brain injury
研究概览
简要总结
This study determines the effectiveness of cerebral Near Infrared Spectroscopy (NIRS) as a monitoring device combined with a SafeboosC treatment guideline in order to prevent brain injury in very low birth weight preterm neonates. Each experimental and control groups consists of at least 30 participants, and only the experimental group uses cerebral NIRS and a treatment guideline.
详细描述
There are still high number of preterm mortality and morbidity in Indonesia. Preterm infants are susceptible to get brain injury due to hemodynamic changes and loss of cerebral autoregulation. Some studies showed that fluctuated changes of brain blood flow caused intraventricular hemorrhage (IVH), and the decreasing of brain blood flow lead to a hypoxic- ischemic state which had role for periventricular leucomalacia (PVL) formation. These result a long term neurologic deficit outcome such as cerebral palsy and cognitive impairment. The standard measures that mainly performed in the NICU were systemic arterial oxygenation and mean arterial blood pressure. There is not yet routine procedure to measure the brain perfusion and oxygenation in Indonesia.
Cerebral Near Infrared Spectroscopy (NIRS) is an invasive tool that continuously measures brain tissue hemoglobin oxygen saturation (rStO2) and determines cerebral circulation. The mechanism of NIRS is based on the light absorption by the hemoglobin, which the value reflects the ratio of oxygenated hemoglobin concentration to total hemoglobin in the penetrated tissue.
To prevent the permanent neurological damage from hypoxia or hyperoxia events, the investigators use cerebral NIRS combined with SafeboosC (Safeguarding the brain of our smallest children) treatment guidelines. The research programme SafeboosC phase II trial hypothesizes that the burden of hypoxia and hyperoxia can be reduced among preterm. The investigators recruit eligible neonates who are admitted in our neonatal intensive care unit and randomly assign them into 2 groups after a written informed consent was approved by the parents. One group uses cerebral NIRS as a monitoring device and performed a treatment guideline to maintain a normal value of rStO2. The other group receives standard treatment without placement of cerebral NIRS. A routine brain ultrasonography is done in both groups to evaluate brain injury (PVL or IVH).
Significance testing is done by Chi-square or Fisher's exact test as needed.
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
- 3 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Neonates born in dr. Cipto Mangunkusumo Hospital and admitted in the neonatal intensive care unit
- •Gestational age ≤ 32 weeks and/or birth weight ≤ 1500grams
排除标准
- •Parents refuse to participate
- •Participants who are not able to use cerebral NIRS in the first 3 hours of life
- •Participants with congenital malformation and cerebral complications during delivery
- •Participants who are diagnosed with IVH/PVL in the first 3 hours of life (confirmed with brain ultrasonography examination and assessed by radiology pediatric specialist)
结局指标
主要结局
72 hours preterm brain injury
时间窗: 72 hours
Brain ultrasonography at 72 hours of age is assessed by pediatric radiology specialist. Brain injury is positive when there are intraventricular or periventricular leukomalacia findings in the brain ultrasonography result.
次要结局
- Mortality rates(28 days)
研究者
Lily Rundjan
MD
Dr Cipto Mangunkusumo General Hospital