Pentoxifylline Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Necrotizing Enterocolitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Mortality rate
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis.
详细描述
This randomized clinical trial includes 75 preterm infants who met the inclusion criteria for stage I and stage II NEC. Patients are allocated randomly into three groups (each included 25 neonates); group I (traditional therapy group) received antibiotics according to culture and sensitivity results, group II (pentoxifylline group) received antibiotics and IV pentoxifylline at a dose of 30 mg/ Kg given over 6 hours daily until discharge from the unit, and group III (probiotics group) received antibiotics and probiotics sachets supplementation in a dose of 100 mg mixed with 10 ml sterile water and given by Ryle tube once daily until discharge. The serum level of high-mobility group box protein 1 (HMGB-1), intestinal fatty acid binding proteins (I-FABP), and total antioxidant capacity (TAC) were measured on admission and at discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female preterm neonates less than 37 weeks gestational age
- •Suffering from necrotizing enterocolitis (NEC), according to Modified Bell's system which was first proposed by Bell et al., 1978 as stage I (suspected), II (proven) .
- •Diagnosis of NEC depends on; history, physical examination, laboratory and radiographic findings .
- •Signs and symptoms of NEC (at least three or more ), including; unstable temperature, apnea, increased residual milk in stomach, mid abdominal distension, vomiting coffee-like substances, bloody stool
- •Laboratory findings including; thrombocytopenia, hypernatremia, metabolic acidosis, neutropenia and leukocytosis.
- •Anterior posterior abdominal radiograph is used for diagnosis in which pneomatosis intestinalis in stage II NEC
排除标准
- •Term and post term neonates
- •Neonates with congenital infections
- •Neonates with major congenital anomalies
- •Neonates with stage III NEC
研究组 & 干预措施
pentoxifylline group (group II)
will include 25 preterm neonates with NEC who will receive traditional therapy of NEC in association with IV pentoxifylline at a dose of 30 mg/kg given over 6 hours daily (Schüller et al., 2020) until discharge from the unit after clinical and laboratory improvement .
干预措施: Pentoxifylline (Drug)
probiotic group (group III)
will include 25 preterm neonates with NEC who will receive traditional therapy of NEC in association with probiotics sachets supplementation, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement .
干预措施: Probiotic Formula (Drug)
结局指标
主要结局
Mortality rate
时间窗: 2 months
record mortality rate in each group during treatment
Inflammatory parameter
时间窗: 2 months
Change in serum C-reactive protein at baseline and after 2 months
complications and side effects
时间窗: 2 months
record any complications or side effects of the treating drugs
次要结局
- change in serum high-mobility group box protein 1 (HMGB1)(2 months)
- change in serum Intestinal fatty acid binding protein (I-FABP).(2 months)
- change in serum total antioxidant capacity (TAC)(2 months)
研究者
Alaa Mohamed Ahmed Rowisha
clinical pharmacist
Tanta University