<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/NCT01713127</url>
  </required_header>
  <id_info>
    <org_study_id>RFTN-02</org_study_id>
    <secondary_id>12077</secondary_id>
    <nct_id>NCT01713127</nct_id>
  </id_info>
  <brief_title>Remifentanil in Ventilated Preterm Infants</brief_title>
  <official_title>Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>DongGuk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate efficacy of remifentanil in preterm infants during&#xD;
      ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    declined enrollment&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>premature infant pain profile (PIPP)</measure>
    <time_frame>24hours after remifentanil/placebo infusion</time_frame>
    <description>PIPP measure during tracheal suction window period ; +/- 1hr</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intraventricular hemorrhage</measure>
    <time_frame>up to 1 week of age</time_frame>
    <description>intraventricular hemorrhage documented by sonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pneumothorax</measure>
    <time_frame>up to 1 week of age</time_frame>
    <description>pneumothorax documented by X-ray or sonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bronchopulmonary dysplasia</measure>
    <time_frame>28 days of age</time_frame>
    <description>O2 dependency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of ventilator care</measure>
    <time_frame>up to 4 months of age</time_frame>
    <description>mechanical ventilator dependency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital day</measure>
    <time_frame>upto 4 months of age</time_frame>
    <description>days from admission to discharge from neonatal intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to full feeding</measure>
    <time_frame>up to 2 months of age</time_frame>
    <description>day of life when the baby reaches full enteral feeding, defined as a volume above 120 mL/kg/day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>up to 4 months of age</time_frame>
    <description>in-hospital death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>development of adverse effects</measure>
    <time_frame>from the start of remifentanil infusion to 1 hour after end of infusion</time_frame>
    <description>category of adverse effects&#xD;
General appearance Fever or Hypothermia, Rash&#xD;
Respiratory &amp; Cardiovascular Arrhythmia Tachypnea (RR &gt;100/min) Desaturation (SpO2 &lt;80%) Hypotension (inotropics use or need volume challenge) Bradycardia (HR &lt;80/min) Tachycardia (HR &gt;200/min)&#xD;
Gastrointestinal Abdominal distension Bilious gastric remain Vomiting Bloody Stool Necrotizing Enterocolitis&#xD;
Renal Oliguria (U/O &lt; 1.0cc/kg/day)&#xD;
Neurologic Seizure Cerebral infarction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Preterm Infants</condition>
  <condition>Mechanical Ventilator Care</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth</description>
  </arm_group>
  <arm_group>
    <arm_group_label>remifentanil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>remifentanil infusion</intervention_name>
    <arm_group_label>remifentanil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  preterm infants (&lt;37weeks of gestational age)&#xD;
&#xD;
          -  requiring ventilator care&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major anomaly&#xD;
&#xD;
          -  48hrs after birth&#xD;
&#xD;
          -  requiring operation during drug infusion&#xD;
&#xD;
          -  cord blood pH &lt; 7.0&#xD;
&#xD;
          -  intraventricular hemorrhage grade III or more&#xD;
&#xD;
          -  investigators decision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>48 Hours</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Children's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>November 18, 2015</last_update_submitted>
  <last_update_submitted_qc>November 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Remifentanil</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01713127
org study id: RFTN-02
secondary id: 12077
nct id: NCT01713127
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate efficacy of remifentanil in preterm infants during
      ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: premature infant pain profile (PIPP)
time frame: 24hours after remifentanil/placebo infusion
description: PIPP measure during tracheal suction window period ; +/- 1hr
measure: intraventricular hemorrhage
time frame: up to 1 week of age
description: intraventricular hemorrhage documented by sonography
measure: pneumothorax
time frame: up to 1 week of age
description: pneumothorax documented by X-ray or sonography
measure: bronchopulmonary dysplasia
time frame: 28 days of age
description: O2 dependency
measure: duration of ventilator care
time frame: up to 4 months of age
description: mechanical ventilator dependency
measure: hospital day
time frame: upto 4 months of age
description: days from admission to discharge from neonatal intensive care unit
measure: time to full feeding
time frame: up to 2 months of age
description: day of life when the baby reaches full enteral feeding, defined as a volume above 120 mL/kg/day
measure: mortality
time frame: up to 4 months of age
description: in-hospital death
measure: development of adverse effects
time frame: from the start of remifentanil infusion to 1 hour after end of infusion
description: category of adverse effects
General appearance Fever or Hypothermia, Rash
Respiratory & Cardiovascular Arrhythmia Tachypnea (RR >100/min) Desaturation (SpO2 <80%) Hypotension (inotropics use or need volume challenge) Bradycardia (HR <80/min) Tachycardia (HR >200/min)
Gastrointestinal Abdominal distension Bilious gastric remain Vomiting Bloody Stool Necrotizing Enterocolitis
Renal Oliguria (U/O < 1.0cc/kg/day)
Neurologic Seizure Cerebral infarction
arm group label: Placebo
arm group type: Placebo Comparator
description: 5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth
arm group label: remifentanil
arm group type: Active Comparator
description: 0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth
intervention type: Drug
intervention name: remifentanil infusion
arm group label: remifentanil
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: N/A
maximum age: 48 Hours
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Remifentanil