<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02980250</url>
  </required_header>
  <id_info>
    <org_study_id>NFEC-2015-131</org_study_id>
    <nct_id>NCT02980250</nct_id>
  </id_info>
  <brief_title>Multi-Center Study of Different Doses Domperidone in Feeding Intolerance</brief_title>
  <acronym>MCSDDDFI</acronym>
  <official_title>A Clinical Multi-Center Study of Efficacy Analysis in Different Doses of Domperidone in Feeding Intolerance of Premature Infant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangdong Provincial Maternal and Child Health Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shen-Zhen City Maternity and Child Healthcare Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maternal and Child Health Hospital of Foshan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangzhou Panyu Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical multi-center study is to determine whether different doses of&#xD;
      domperidone are effective in the treatment of feeding intolerance in premature infant&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the premature infant have been divided into four group.The first group take the 0.2mg/kg/tds&#xD;
      domperidone as treatment ,while the other group take the 0.4mg/kg/tds&#xD;
      domperidone,0.6mg/kg/tds domperidone and the placebo respectively .&#xD;
&#xD;
      An objective index has been decided to evaluate the severity of feeding intolerance in the&#xD;
      premature infant. 3kg/kg 5% glucose will be injected into the gastric tube .The residual&#xD;
      glucose will be drawed out from the gastric tube. The residual percentage is the main result&#xD;
      of the study.&#xD;
&#xD;
      The main result will be compared by the secondary result to help to explain the accuracy. The&#xD;
      secondary result is the percentage of residual milk drawed out from the gastric tube from how&#xD;
      many milk the infant take 3 hours ago.&#xD;
&#xD;
      Any adverse effect will be recorded and analysed to figure out whether is associate with the&#xD;
      domperidone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the residual glucose percentage</measure>
    <time_frame>7 days</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the percentage of residual milk</measure>
    <time_frame>7 days</time_frame>
    <description>the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>1 month</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Feeding Intolerance</condition>
  <condition>Premature Birth</condition>
  <condition>Domperidone Overdose</condition>
  <condition>Gastric Retention</condition>
  <arm_group>
    <arm_group_label>low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>over dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose</intervention_name>
    <description>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.</description>
    <arm_group_label>low dose</arm_group_label>
    <other_name>Domperidone Suspension(Motilium), B12200018238</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal dose</intervention_name>
    <description>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.</description>
    <arm_group_label>normal dose</arm_group_label>
    <other_name>Domperidone Suspension(Motilium), B12200018238</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>over dose</intervention_name>
    <description>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.</description>
    <arm_group_label>over dose</arm_group_label>
    <other_name>Domperidone Suspension(Motilium), B12200018238</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glucose</intervention_name>
    <description>Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>5% Glucose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the residual milk and glucose over 55%&#xD;
&#xD;
          -  abdominal distention or vomiting;&#xD;
&#xD;
          -  Reduce,delay or disruption of enteral feeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Four weeks before the start of this study had participated in other clinical trials&#xD;
&#xD;
          -  pulmonary hypertension;&#xD;
&#xD;
          -  Infants with necrotizing enterocolitis&#xD;
&#xD;
          -  Gastrointestinal tract malformation, congenital heart disease&#xD;
&#xD;
          -  Pre-existing QT extend/between long QT syndrome;&#xD;
&#xD;
          -  ascites&#xD;
&#xD;
          -  Have been used or will use drugs suppress CYP3A4&#xD;
&#xD;
          -  Other risk factors for prolong the QT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Weeks</minimum_age>
    <maximum_age>35 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>WeiMing Huang, professor</last_name>
    <role>Study Chair</role>
    <affiliation>Nanfang Hosiptal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nanfang Hospital of Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanfang Hospital, Southern Medical University</investigator_affiliation>
    <investigator_full_name>Weimin Huang</investigator_full_name>
    <investigator_title>The director of the neonatology department</investigator_title>
  </responsible_party>
  <keyword>feeding intolerance</keyword>
  <keyword>premature infant</keyword>
  <keyword>domperidone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Domperidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02980250
org study id: NFEC-2015-131
nct id: NCT02980250
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: the residual glucose percentage
time frame: 7 days
description: 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
measure: the percentage of residual milk
time frame: 7 days
description: the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 1 month
arm group label: low dose
arm group type: Experimental
description: 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.
arm group label: normal dose
arm group type: Experimental
description: 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.
arm group label: over dose
arm group type: Experimental
description: 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.
arm group label: placebo
arm group type: Placebo Comparator
description: 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.
intervention type: Drug
intervention name: Low dose
description: 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.
arm group label: low dose
other name: Domperidone Suspension(Motilium), B12200018238
intervention type: Drug
intervention name: normal dose
description: 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.
arm group label: normal dose
other name: Domperidone Suspension(Motilium), B12200018238
intervention type: Drug
intervention name: over dose
description: 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.
arm group label: over dose
other name: Domperidone Suspension(Motilium), B12200018238
intervention type: Drug
intervention name: Glucose
description: Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.
arm group label: placebo
other name: 5% Glucose
criteria: 
gender: All
minimum age: 20 Weeks
maximum age: 35 Weeks
healthy volunteers: No
last name: WeiMing Huang, professor
role: Study Chair
affiliation: Nanfang Hosiptal
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanfang Hospital, Southern Medical University
investigator full name: Weimin Huang
investigator title: The director of the neonatology department
mesh term: Premature Birth
mesh term: Domperidone
sharing ipd: No