Caffeine Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Bronchopulmonary Dysplasia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Liver function test
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of caffeine versus probiotics supplementation as adjuvant therapy for preterm neonates with Bronchopulmonary dysplasia (BPD).
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
- 0 Weeks 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 Bronchopulmonary dysplasia (BPD) diagnosed as follow:
- •History: Preterm infant with persistence oxygen dependency up to 28 days of life.
- •Clinical signs: increase work of breathing, increase oxygen requirements , increase in apnea , bradycardia and retraction.
- •Laboratory: arterial blood gases and electrolytes.
- •Radiology: streaky interstitial markings, patchy atelectasis , intermingled with cystic areas and severe lung hyperinflation.
排除标准
- •Term and post term neonates
- •Neonates with congenital infections
- •Neonates with major congenital anomalies
研究组 & 干预措施
caffeine group (group II)
will include 30 preterm neonates with BPD who will receive traditional therapy of BPD in association with caffeine by intravenous route at a dose of 20 mg/kg loading dose with a 5-10 mg/kg/day maintenance dose given after 24 h ( Yuan et al., 2022) until discharge from the unit after clinical and laboratory improvement after two months.
干预措施: Caffeine (Drug)
probiotic group (group III)
will include 30 preterm neonates with BPD who will receive traditional therapy of BPD in association with probiotics sachets supplementation orally, 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 after two months
干预措施: Probiotic Formula (Drug)
结局指标
主要结局
Liver function test
时间窗: 2 months
Changes in aspartate aminotransferase and alanine aminotransferase at baseline and after 2 months
Kidney function test
时间窗: 2 months
Changes in creatinine clearance at baseline and after 2 months
Inflammatory parameter
时间窗: 2 months
changes in serum C-reactive protein at baseline and after 2 months
Complete blood count
时间窗: 2 months
Changes in blood parameters at baseline and after 2 months
次要结局
- change in Serum Tumor necrosis factor alpha (TNF-α)(2 months)
- change in serum transforming growth factor (TGF)-β.(2 months)
- change in Serum superoxide dismutase (SOD)(2 months)
研究者
Ahmed Ehab Fawzy Mohamed
clinical pharmacist
Tanta University