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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230910004
Enrollment
96
Registered
2023-09-10
Start date
2022-12-20
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactation failure in mothers of preterm newborn Domperidone, Breast Milk, Preterm Mother, Galactagogue

Interventions

Prescribed 6 weeks of domperidone drug,Prescribed 4 weeks of domperidone drug and 2 weeks of placebo,Prescribed 6 weeks of placebo
Domperidone 6 weeks,Domperidone 4 weeks Then Placebo 2 weeks,Placebo 6 weeks

Sponsors

Prapokklao Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Breast Milk Volume 6 weeks Breast Milk Volume

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactPaphada Raksasuk

Prapokklao hospital

ormormpr@gmail.com0919541556

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026