The Effects of Maternal Domperidone Intake on the Growth of Their Preterm Neonates in Kabul City: A Randomized Clinical Trial
- Conditions
- Prematurity and low birth wieghtP07Disorders related to short gestation and low birth weight, not elsewhere classified
- Registration Number
- DRKS00022844
- Lead Sponsor
- Kabul University of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 90
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - 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.<br>- 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. <br>
- Secondary Outcome Measures
Name Time Method - The risk of neonatal death during the hospital stay.<br>- The risk of maternal breast discomforts including, tenderness, swelling and pain.<br>- The risk of maternal respiratory and gastrointestinal discomforts including difficult breathing, diarrhea, and stomach cramp.<br>- The risk of maternal cardiac arrhythmia detected in ECG. <br> <br>