Effect of DHA on Proinflammatory Cytokines Including Platelets Activating Factor (PAF) and it's Role in Prevention of Necrotizing Enterocolitis in Preterm/Very Low Birth Weight Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- DEVELOPMENT OF NEC
研究概览
简要总结
The purpose of this study is to determine whether docosahexaenoic acid is effective in the prevention or reducing severity of necrotizing enterocolitis in preterm/low birth weight neonates.Necrotizing enterocolitis (NEC) is the most devastating gastrointestinal disease in neonates. The pathogenesis of NEC is not well defined but evidence strongly suggests that it is multifactorial . prematurity and enteral feeding are major risk factors for NEC. An excessive inflammatory response by the immature intestine to external stimuli, impaired intestinal barrier integrity and / or abnormal bacterial colonization are key factors implicated in pathophysiology of NEC.
详细描述
Inclusion criteria:
Patients are eligible for inclusion if they meet the following criteria:
Preterm neonates having a gestational age equal or less than 32 weeks at birth, admitted in Ain Shams University NICU'S.
Weight (less than or equal 1.500 KG) Clinically stable to begin enteral feeding All Genders (Male, Female) Written informed consent by parents Sepsis will not be considered as exclusion criteria (according to SNAP 11; this score considers six physiologic variables such as blood pressure, temperature, the Po2/Fio2 ratio, serum PH, seizures and urine output, Töllner score (table 3) and Rodwell score (table 4)).
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates having a gestational age equal or less than 32 weeks at birth, admitted in Ain Shams University NICU'S.
- •Weight (less than or equal 1.500 KG) Clinically stable to begin enteral feeding All Genders (Male, Female) Written informed consent by parents Sepsis will not be considered as exclusion criteria (according to SNAP 11; this score considers six physiologic variables such as blood pressure, temperature, the Po2/Fio2 ratio, serum PH, seizures and urine output, Töllner score (table 3) and Rodwell score
排除标准
- •Persistent bleeding at any level. Receiving medication to avoid coagulation. Persistent vomiting. Gastrointestinal malformations. Mother taking Omega-3 supplements and planning to breastfed.
结局指标
主要结局
DEVELOPMENT OF NEC
时间窗: 3-10 DAYS
All infants will undergo follow-up from birth until reach 37 week corrected gestational age, discharge or death whichever comes first. The following primary outcome data will be recorded: Clinical examination and radiological investigations when clinically indicated for evidence of NEC.
次要结局
未报告次要终点