<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/NCT03024814</url>
  </required_header>
  <id_info>
    <org_study_id>HRC-09-Nov15-02</org_study_id>
    <nct_id>NCT03024814</nct_id>
  </id_info>
  <brief_title>Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants</brief_title>
  <official_title>Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud Medical City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Saud Medical City</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether acetaminophen is effective in prevention or&#xD;
      reducing the severity of IVH in premature infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It will be a double-blind randomized control trial, single center. The study will include&#xD;
      neonates with a gestational age of less than or equal 32 weeks and a birth weight of less&#xD;
      than or equal 1500 g, and will randomly assigned to two treatment groups (see below).&#xD;
&#xD;
      Infants will be randomized to equal-sized groups using block randomization with blocks of&#xD;
      four. Stratified randomization for gender and gestational age will be included in the&#xD;
      randomized blocks. Gestational age will be divided into two categories: 23 weeks +0 day to 27&#xD;
      weeks +6 days, and from 28 weeks +0 day to 32 weeks +6 days. Gender (2) × gestational age (2)&#xD;
      will give 6 strata, requiring 6 separate random number lists to achieve randomization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <phase>Phase 3</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of intraventricular hemorrhage (IVH will be graded by Papile score) among the infants on acetaminophen compared to the infants on placebo.</measure>
    <time_frame>within the first week of age</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of neonatal sepsis in the premature babies who received acetaminophen</measure>
    <time_frame>Corrected 40 weeks of gestational age or time of discharge will be used</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of Necrotizing Enterocolitis (NEC) in the premature babies who received acetaminophen</measure>
    <time_frame>Corrected 40 weeks of gestational age or time of discharge will be used</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of bronchopulmonary dysplasia (BPD) in the premature babies who received acetaminophen</measure>
    <time_frame>Corrected 40 weeks of gestational age or time of discharge will be used</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Intraventricular Haemorrhage Neonatal</condition>
  <arm_group>
    <arm_group_label>acetaminophen group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Babies who took acetaminophen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group (Dextrose 5)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Babies who took placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>The first group will receive acetaminophen as the following&#xD;
Loading dose: 20 mg/kg in the first 12-24 hours To be diluted in D5W up to 3-5 ml and to be infused over 15 minutes.&#xD;
Maintenance dose: 7.5 mg/kg after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days.</description>
    <arm_group_label>acetaminophen group</arm_group_label>
    <other_name>Paracetamol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dextrose 5</intervention_name>
    <description>The second group will receive placebo (D5W) as the following&#xD;
Loading dose: 3-5 ml in the first 12-24 hours To be infused over 15 minutes.&#xD;
Maintenance dose: 3-5 ml after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days.</description>
    <arm_group_label>Placebo group (Dextrose 5)</arm_group_label>
    <other_name>Dextrose 5%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premature baby less than or equal 32 week and birth weight less than or equal 1500 g&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Out-born babies, infants with major congenital anomalies, babies have IVH III, IV,&#xD;
             High expectancy of early death&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Hour</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mountasser Al-Mouqdad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Saud Medical City</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mountasser Al-Mouqdafd, MD</last_name>
    <phone>00966539095090</phone>
    <email>m.almouqdad@ksmc.med.sa</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mountasser Al-Mouqdad</name>
      <address>
        <city>Riyadh</city>
        <zip>11196</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mountasser Al-Mouqdad, MD</last_name>
      <phone>00966539095090</phone>
      <email>m.almouqdad@ksmc.med.sa</email>
    </contact>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 14, 2017</last_update_submitted>
  <last_update_submitted_qc>January 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Saud Medical City</investigator_affiliation>
    <investigator_full_name>Mountasser Al-Mouqdad</investigator_full_name>
    <investigator_title>NICU consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</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/NCT03024814
org study id: HRC-09-Nov15-02
nct id: NCT03024814
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether acetaminophen is effective in prevention or
      reducing the severity of IVH in premature infants.
It will be a double-blind randomized control trial, single center. The study will include
      neonates with a gestational age of less than or equal 32 weeks and a birth weight of less
      than or equal 1500 g, and will randomly assigned to two treatment groups (see below).

      Infants will be randomized to equal-sized groups using block randomization with blocks of
      four. Stratified randomization for gender and gestational age will be included in the
      randomized blocks. Gestational age will be divided into two categories: 23 weeks +0 day to 27
      weeks +6 days, and from 28 weeks +0 day to 32 weeks +6 days. Gender (2) × gestational age (2)
      will give 6 strata, requiring 6 separate random number lists to achieve randomization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The incidence of intraventricular hemorrhage (IVH will be graded by Papile score) among the infants on acetaminophen compared to the infants on placebo.
time frame: within the first week of age
measure: The incidence of neonatal sepsis in the premature babies who received acetaminophen
time frame: Corrected 40 weeks of gestational age or time of discharge will be used
measure: The incidence of Necrotizing Enterocolitis (NEC) in the premature babies who received acetaminophen
time frame: Corrected 40 weeks of gestational age or time of discharge will be used
measure: The incidence of bronchopulmonary dysplasia (BPD) in the premature babies who received acetaminophen
time frame: Corrected 40 weeks of gestational age or time of discharge will be used
arm group label: acetaminophen group
arm group type: Experimental
description: Babies who took acetaminophen
arm group label: Placebo group (Dextrose 5)
arm group type: Experimental
description: Babies who took placebo
intervention type: Drug
intervention name: Acetaminophen
description: The first group will receive acetaminophen as the following
Loading dose: 20 mg/kg in the first 12-24 hours To be diluted in D5W up to 3-5 ml and to be infused over 15 minutes.
Maintenance dose: 7.5 mg/kg after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days.
arm group label: acetaminophen group
other name: Paracetamol
intervention type: Drug
intervention name: Dextrose 5
description: The second group will receive placebo (D5W) as the following
Loading dose: 3-5 ml in the first 12-24 hours To be infused over 15 minutes.
Maintenance dose: 3-5 ml after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days.
arm group label: Placebo group (Dextrose 5)
other name: Dextrose 5%
criteria: 
gender: All
minimum age: 1 Hour
maximum age: 6 Months
healthy volunteers: No
last name: Mountasser Al-Mouqdad, MD
role: Principal Investigator
affiliation: King Saud Medical City
last name: Mountasser Al-Mouqdafd, MD
phone: 00966539095090
email: m.almouqdad@ksmc.med.sa
facility: 
status: Recruiting
contact: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Saud Medical City
investigator full name: Mountasser Al-Mouqdad
investigator title: NICU consultant
mesh term: Cerebral Hemorrhage
mesh term: Hemorrhage
mesh term: Acetaminophen
sharing ipd: No