TCTR20230910004已完成4 期
Effect of Domperidone on the Breast Milk Volume of Mothers of Preterm Newborn at Prapokklao Hospital; A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 89
研究概览
简要总结
The mean of breast milk volume at the 6th weeks postpartum of domperidone only group is much more than placebo with clinically and statistically significance (1006 +/- 451 vs 745 +/- 311, p 0.046) but domperidone only group is greater breast milk volume than domperidone 4 weeks followed by placebo 2 weeks with only clinically significance (1006 +/- 451 vs 838 +/- 430) parallel with the result of domperidone 4 weeks followed by placebo 2 weeks compared with placebo (838 +/- 430 vs 745 +/- 311)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- Female
入选标准
- •1. Mothers who have neonate in GA < 37 weeks
- •2. > 18 years old Mothers
- •3. Communicable in Thai or English
- •4. Acceptance to be participants
排除标准
- •1. Cannot breast feeding (eg. drug abuse, alcoholism, HIV infected etc.)
- •2. Mammoplasty with periareolar incision or Nipple and areola transplanted
- •3. Prolactin-releasing tumor
- •4. Allergy to Domperidone
- •5. History of Heart diseases or Abnormal ECG (QT Prolong, Bradycardia, Ventricular arrhythmia, Sudden cardiac arrest)
- •6. Currently on Antiarrhythmic drugs and drugs interfering to the Domperidone mechanism (eg. azole- drugs, antifungals, macrolides, monoamine oxidase inhibitors)
- •7. Chronic illness, Moderate to severe liver impairment (Child-Pugh >=7) , Gastric abnormalities, Severe renal impairment (serum creatinine > 6 mg/100 mL, i.e. > 0.6 mmol/L)
- •8. Smoking during pregnancy
- •9. Hypo-/Hyperkalemia or Hypomagnesemia
- •10. Unavailable to feeding in every 2-3 hours
研究者
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