Multi-Center Study of Different Doses Domperidone in Feeding Intolerance

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Feeding Intolerance, Premature Birth, Domperidone Overdose, Gastric Retention

Intervention / Treatment
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* Drug: Low dose
* Drug: normal dose
* Drug: over dose
* Drug: Glucose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the residual milk and glucose over 55% abdominal distention or vomiting; Reduce,delay or disruption of enteral feeding Exclusion Criteria: Four weeks before the start of this study had participated in other clinical trials pulmonary hypertension; Infants with necrotizing enterocolitis Gastrointestinal tract malformation, congenital heart disease Pre-existing QT extend/between long QT syndrome; ascites Have been used or will use drugs suppress CYP3A4 Other risk factors for prolong the QT

Ages Eligible for Study
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Minimum Age: 20 Weeks
Maximum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low dose<br>The premature infant in this group will be feed with 0.2mg/kg/tds domperidone suspension(motilium;100ml)for 7 days and will be tested the residual percentage everyday. | Drug: Low dose<br>* 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.<br>* Other names: Domperidone Suspension(Motilium), B12200018238;|
| Experimental: normal dose<br>The premature infant in this group will be feed with 0.4mg/kg/tds domperidone suspension(motilium;100ml)for 7 days and will be tested the residual percentage everyday. | Drug: normal dose<br>* 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.<br>* Other names: Domperidone Suspension(Motilium), B12200018238;|
| Experimental: over dose<br>The premature infant in this group will be feed with 0.6mg/kg/tds domperidone suspension(motilium;100ml)for 7 days and will be tested the residual percentage everyday. | Drug: over dose<br>* 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.<br>* Other names: Domperidone Suspension(Motilium), B12200018238;|
| Placebo Comparator: placebo<br>The premature infant in this group will be feed with some vitamin which will dilute into the 5% glucose and have the same appearance and taste with the experimental team for 7 days and will be tested the residual percentage everyday. | Drug: Glucose<br>* Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.<br>* Other names: 5% Glucose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the residual glucose percentage | 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 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of residual milk | the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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feeding intolerance, premature infant, domperidone