Serum Erythropoietin Level for Detection of Kidney and Brain Injuries in Asphyxiated Neonates in Neonatal Intensive Care Unit.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- correlation between serum erythropoietin level and brain injury
研究概览
简要总结
This study is to evaluate brain and kidney injuries in full-term neonates with perinatal asphyxia by detecting specific biomarker in blood (Erythropoietin).
详细描述
Perinatal hypoxic-ischemic encephalopathy (HIE) is an important cause of brain injury in the newborn and can result in long-term devastating consequences. Acute kidney injury (AKI) occurs in (50 - 72%) among asphyxiated term infants. The kidney cells that make erythropoietin are sensitive to low oxygen levels in the blood that travels through the kidney. These cells make and release erythropoietin when the oxygen level is too low.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Day 至 4 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cases group:
- •The presence of a sentinel hypoxic event immediately before or during delivery
- •History of fetal distress (bradycardia, late decelerations, absence of heart rate variability).
- •Need for neonatal resuscitation at delivery
- •One-min Apgar score <3 or 5-minApgar score<7
- •Metabolic acidosis (BE > 10 in cord blood)
- •Cardiocirculatory instability (CCI), clinical indications of hypoxic-ischemic encephalopathy (HIE) and multiple organ involvement (MOI).
- •Control group:
- •Newborns who were delivered normally after uncomplicated pregnancy. None of them have clinical nor biochemical signs of asphyxia.
排除标准
- •Newborns who do not fulfill the above criteria.
- •Newborns with congenital heart diseases and perinatal hemolytic anemia or congenital liver affection.
- •Whose parents refuse to participate in the study.
- •Cases above 4 days old.
- •Preterm neonates (less than 37 weeks).
结局指标
主要结局
correlation between serum erythropoietin level and brain injury
时间窗: first 4 days of life
measure level of serum erythropoietin by ELISA technique and test if can differentiate degree of brain hypoxia
次要结局
未报告次要终点
研究者
Ahmed Mahmoud Ahmed Sayed
Doctor
Cairo University