NCT02980250

Multi-Center Study of Different Doses Domperidone in Feeding Intolerance

A Clinical Multi-Center Study of Efficacy Analysis in Different Doses of Domperidone in Feeding Intolerance of Premature Infant

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 20 Weeks – 35 Weeks
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Feeding Intolerance
• Premature Birth
• Domperidone Overdose
• Gastric Retention

Interventions

Type	Name	Description
DRUG	Low dose	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.
DRUG	normal dose	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.
DRUG	over dose	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.
DRUG	Glucose	Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-05-01
• Completion: 2017-06-01
• First posted: 2016-12-02
• Last updated: 2017-09-15

Locations

1 site across 1 country: China