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The Effects of Maternal Domperidone Intake on the Growth of Their Preterm Neonates in Kabul City: A Randomized Clinical Trial

The Effects of Maternal Domperidone Intake on the Growth of Their Preterm Neonates in Kabul City: A Randomized Clinical Trial - EMDIGPN

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00022844
Enrollment
90
Registered
2021-02-09
Start date
2023-01-30
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Prematurity and low birth wieght P07

Interventions

Group 1: 45 mothers in the study group (Domperidone group) will take one capsule of Domperidone 10mg three times a day orally for two weeks in the postpartum period.The pre-coded drugs would be given

Sponsors

Kabul University of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Days to 35 Years

Inclusion criteria

Inclusion criteria: The mothers aged less than 35y old with preterm delivery and insufficient breast milk (the amount of expressed breast milk become less than the appropriate requirement of babies or the mothers report they have insufficient breast milk) together with their preterm neonates fulfill one of the following criteria will be enrolled in the study. 1-Gestational age of 34 weeks or less. 2-Weight of less than 2000g.

Exclusion criteria

Exclusion criteria: The mothers who have abnormal liver function test, mastitis, twin’s delivery, undergone mastectomy, BMI less than 18, conduction abnormalities on ECG and taking GYP3A4 inhibitors (macrolide, calcium channel blockers, ketoconazole, fluconazole, cimetidine), antipsychotic, antidepressant, tranquilizers, antacids, bromocriptin, and metoclopramide would be excluded from the study. The Neonates have visible or physically detected malformation, birth weight less than 1000g, seriously ill condition, taking probiotic, and the parent who declined consent; are the other exclusion criteria.

Design outcomes

Primary

MeasureTime frame
- The neonatal daily weight gain will be calculated as weight gain in gram during the observation period divided by the number of days in the same period. Neonates must be weighed on day1,7, 14 and 21. - The neonatal weekly enhancement of length and head circumference will be calculated as an increase in length and head circumference in cm during the observation period divided by the number of weeks in the same period.

Secondary

MeasureTime frame
- The risk of neonatal death during the hospital stay. - The risk of maternal breast discomforts including, tenderness, swelling and pain. - The risk of maternal respiratory and gastrointestinal discomforts including difficult breathing, diarrhea, and stomach cramp. - The risk of maternal cardiac arrhythmia detected in ECG.

Countries

Afghanistan

Contacts

Public ContactMansoor Aslamzai

Department of Neonatology, Maiwand Teaching Hospital, Kabul University of Medical Science

mansooraslamzai@gmail.com+93788449693

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026