Multi-Center Study of Different Doses Domperidone in Feeding Intolerance

Overview

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

Full Title of Study: “A Clinical Multi-Center Study of Efficacy Analysis in Different Doses of Domperidone in Feeding Intolerance of Premature Infant”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: May 2017

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: low dose
    • 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.
  • Experimental: normal dose
    • 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.
  • Experimental: over dose
    • 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.
  • Placebo Comparator: placebo
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • the residual glucose percentage
    • 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

Secondary Measures

  • the percentage of residual milk
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Weeks

Maximum Age: 35 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nanfang Hospital, Southern Medical University
  • Collaborator
    • Guangdong Provincial Maternal and Child Health Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Weimin Huang, The director of the neonatology department – Nanfang Hospital, Southern Medical University
  • Overall Official(s)
    • WeiMing Huang, professor, Study Chair, Nanfang Hosiptal

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