Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000, China
NCT Number: NCT02980250
The purpose of this clinical multi-center study is to determine whether different doses of domperidone are effective in the treatment of feeding intolerance in premature infant
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Notify Me20 week–35 week
All sexes
Interventional
Phase 4
Guangzhou, Guangdong, 510000, China
the premature infant have been divided into four group.The first group take the 0.2mg/kg/tds domperidone as treatment ,while the other group take the 0.4mg/kg/tds domperidone,0.6mg/kg/tds domperidone and the placebo respectively .
An objective index has been decided to evaluate the severity of feeding intolerance in the premature infant. 3kg/kg 5% glucose will be injected into the gastric tube .The residual glucose will be drawed out from the gastric tube. The residual percentage is the main result of the study.
The main result will be compared by the secondary result to help to explain the accuracy. The secondary result is the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.
Any adverse effect will be recorded and analysed to figure out whether is associate with the domperidone.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.2mg group-The premature infant will be fed with 0.2mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.
Other names: Domperidone Suspension(Motilium), B12200018238
0.4mg group-The premature infant will be fed with 0.4mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.
Other names: Domperidone Suspension(Motilium), B12200018238
0.6mg group-The premature infant will be fed with 0.6mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.
Other names: Domperidone Suspension(Motilium), B12200018238
Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.
Other names: 5% Glucose
Time frame: 7 days
3kg/kg 5% glucose will be injected into the gastric tube .The residual glucose will be drawed out from the gastric tube after 30 min
Time frame: 7 days
the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.
Time frame: 1 month
Nanfang Hospital, Southern Medical University
Other
A Clinical Multi-Center Study of Efficacy Analysis in Different Doses of Domperidone in Feeding Intolerance of Premature Infant
Acronym: MCSDDDFI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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