Evaluation of the Incidence of Necrotizing Enterocolitis in Preterm Infants With Respiratory Distress Syndrome Undergoing Caffeine Therapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- decreasing NEC rates
研究概览
简要总结
It is a randomized, prospective study; it will be carried out in the NICU at Alzahraa University Hospital including 50 newborn babies diagnosed with respiratory distress syndrome.
The purpose of this study is to :
- Investigate the protective caffeine on necrotizing enterocolitis in respiratory distress syndrome preterm infants.
- Detect the impact of caffeine protocol treatment on the in-incidence of necrotizing enterocolitis in respiratory distress syndrome preterm infants in neonatal intensive care
1- Control group It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks.
2- Caffeine-treated group It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 32 Weeks 至 35 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All preterm infants with respiratory distress syndrome.
排除标准
- •Preterm admitted to NICU for other reasons rather than respiratory distress
- •Major congenital anomalies
- •spontaneous intestinal perforation
- •Endocrinal Dysfunctions
研究组 & 干预措施
Control group
It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks receives regular intervention for RDS
干预措施: Amikacin (Drug)
Caffeine-treated group
It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection.
干预措施: Caffeine citrate (Drug)
结局指标
主要结局
decreasing NEC rates
时间窗: 1 year
decreasing NEC rates and stage ≥2 and death.
次要结局
未报告次要终点
研究者
Gellan Alaa Mohamed Kamel Morsy
Lecturer of pharmacology and toxicology
Al-Azhar University