Effect of Domperidone on the Breast Milk Volume of Mothers of Preterm Newborn at Prapokklao Hospital; A Randomized Controlled Trial

Phase 4

Completed

• Conditions: actation failure in mothers of preterm newborn; Domperidone, Breast Milk, Preterm Mother, Galactagogue

• Registration Number: TCTR20230910004
• Lead Sponsor: Prapokklao Hospital

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-07-16
• Study Start: 2023-09-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 89

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breast Milk Volume 6 weeks Breast Milk Volume

Secondary Outcome Measures

Name	Time	Method
Side effects 6 weeks Porportion of side effects,Neonatal outcome 6 weeks Weight, Number of defecation, Number of waking up, Jaundice,Maternal outcome 6 weeks depression propotions, Decreased weight