Autophagy, Mitophagy, Inflammation and Plasmatic Concentration of Melatonin in Newborn With Metabolic Acidosis at Birth
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- change from baseline ATG5 Plasma concentration at 7 days of life
研究概览
简要总结
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Neonatal encephalopathy (NE) occurs in 1.8 to 7.7 infants per 1000 births. Over the last six years, several randomized control trials have demonstrated that therapeutic hypothermia reduces the rate of death or disability at 18 months of age among infants who survived. However, the neurodevelopmental outcome in milder NE not treated with hypothermia remains unclear.
A multicenter prospective observational study will be conducted to determine biological changes of mild neonatal encephalopathy who are not recruited for therapeutic hypothermia .
详细描述
It is a prospective observational multicenter study on 50 newborns with mild neonatal encephalopathy and metabolic acidosis at birth not qualified for therapeutic hypothermia compared to healthy controls.
Infants with metabolic acidosis at birth and evidence of mild encephalopathy graded according to Sarnat&Sarnat neurological evaluation will be recruited to evaluate plasma concentration of melatonin and levels of Autophagy, mitophagy and inflammation.
Plasmatic changes will be compared to:
- healthy control
- infants with isolated metabolic acidosis at birth and normal neurological evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Minutes 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •gestational age > 35 weeks and weight > 1800 gr
- •Apgar score < 5 at 10 minutes o need for cardiopulmonary resuscitation at 10 minutes or evidence of base excess > 12 mmol/L or pH < 7,0 at initial blood gas analyses
- •evidence of mild encephalopathy graded according to Sarnat&Sarnat neurological evaluation
- •normal amplitude integrated electroencephalography
排除标准
- •suspected inborn errors of metabolism
- •major chromosomal congenital defects
结局指标
主要结局
change from baseline ATG5 Plasma concentration at 7 days of life
时间窗: birth, 72 hours, 7 days of life
correlation between metabolic acidosis at birth and Autophagy. ELISA test will be used to measure plasma levels of ATG5
次要结局
- change from baseline Parkin and Pink1 Plasma concentration at 7 days of life(birth, 72 hours, 7 days of life)
研究者
Anna Tarocco
Medical Doctor, Principal Investigator
University Hospital of Ferrara