Role of Vitamin D Therapy in Recovery From Early Neonatal Sepsis (Randomized Controlled Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Role of Vitamin D therapy in recovery from Early Neonatal Sepsis (randomized controlled trial)
研究概览
简要总结
Neonatal sepsis is still a major cause of morbidity and mortality despite major advances in neonatal intensive care units. Early-onset sepsis (EOS) is an infection of the blood acquired vertically from the mother and manifests shortly after birth. The objective of this study is to assess the vitamin D status in neonates with Early onset sepsis (EOS) and evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), in these infants.
详细描述
Subjects:
This is a randomized controlled trial (RCT) conducted on sixty (66) full term newborns with clinical and laboratory findings of early onset of sepsis (EOS) and admitted to the Neonatal Intensive Care Unit of El-Demerdash hospital of Ain Shams university and El Ahrar teaching hospital in Zagazig.
- Inclusion Criteria: full term newborns with clinical and laboratory findings of early onset of sepsis (EOS).
- Exclusion Criteria: Preterm newborn, NPO neonates , infants with maternal risk factors , such as clinical and/or histological chorioamnionitis, neonates delivered at home ,neonates to mothers with premature rupture of membrane, and major congenital abnormalities which may be predisposing factors for development of EOS.
NB: we excluded the dead cases (6 cases) in the final laboratory and clinical relation with serum Vitamin D levels after recovery because sepsis caused death to these neonates and recovery didn't occur .
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 3 Days 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •-Inclusion Criteria: full term newborns with clinical and laboratory findings of early onset of sepsis (EOS).
排除标准
- •Preterm newborn, NPO neonates , infants with maternal risk factors , such as clinical and/or histological chorioamnionitis, neonates delivered at home ,neonates to mothers with premature rupture of membrane, and major congenital abnormalities which may be predisposing factors for development of EOS.
研究组 & 干预措施
Vitamin D 400 IU
neonates with 400 IU supplementation
干预措施: Vitamin D (Drug)
Vitamin D 800 IU
neonates with 800 IU supplementation
干预措施: Vitamin D (Drug)
结局指标
主要结局
Role of Vitamin D therapy in recovery from Early Neonatal Sepsis (randomized controlled trial)
时间窗: nearly 4 years
supplementation of Vitamin D
次要结局
未报告次要终点