Efecto Modulador de la Administracion Del Acido Docosahexaenoico Sobre la Respuesta Inflamatoria, la evolución Clinica y el Estado Nutricional de Neonatos Sometidos a cirugía
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Inflammatory response measured by cytokines IL-1, IL-6, TNF-alfa, IL-10 e IL-1ra and clinical outcomes assessed as frequency of severe sepsis, respiratory and cardiovascular dysfunction.
研究概览
简要总结
The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration attenuates the inflammatory cytokines and improve clinical outcomes in neonates who underwent cardiovascular surgery
详细描述
Severe sepsis and organ failure are leading causes of death in surgical patients. Several studies indicate that a causal relationship exists between the surgical or traumatic injury and the predisposition to develop septic/infectious complications and multiple organ failure; this is attributable to uncontrolled inflammatory response. Since neonates have an immature immune system, they are in a higher risk to develop uncontrolled inflammatory response and adverse clinical outcomes.
N-3 long chain polyunsaturated fatty acids (L-PUFAs) such as docosapentaenoic and docosahexaenoic acids (EPA and DHA) have been shown to reduce the inflammatory response by reducing cytokines, infection rates and length of hospitalization in patients with abdominal surgery. Therefore, acute and enteral administration of DHA may improve clinical outcomes in neonates with cardiovascular surgery
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 45 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Authorization from both parents for recruiting of the neonate into the study with consent signed form after the purpose and procedures have been explained
- •Gestational age older than 32 weeks
- •Adequate weight for gestational age
- •Gastrointestinal tract that allows tolerate the doses of DHA or placebo
- •No signs of Systemic Inflammatory Response Syndrome before the surgery as fever >38 degrees C or hypothermia <36 degrees C, or leukocytosis >19,500 cells/cubic mm or < 5000 cells/cubic mm or > 10% immature forms.
排除标准
- •Fasting for more than two days after surgery
- •Discharge to other hospital outside the metropolitan area
- •Parents who decide to decline of the study
- •Patients who necessitate cardiovascular bypass
结局指标
主要结局
Inflammatory response measured by cytokines IL-1, IL-6, TNF-alfa, IL-10 e IL-1ra and clinical outcomes assessed as frequency of severe sepsis, respiratory and cardiovascular dysfunction.
时间窗: During the hospital stay, two weeks in average
次要结局
未报告次要终点
研究者
Mariela Bernabe García
Researcher
Coordinación de Investigación en Salud, Mexico