xml: <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/NCT05971485</url>
    </required_header>
    <id_info>
      <org_study_id>FMASU MS 496/2022</org_study_id>
      <nct_id>NCT05971485</nct_id>
    </id_info>
    <brief_title>Melatonin as an Analgesic in Preterm Neonate</brief_title>
    <official_title>Efficacy of Melatonin as an Analgesic in Preterm Neonate</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with&#xD;
        several important functions, including regulation of the circadian rhythms, and antioxidant&#xD;
        and anti-inflammatory effects, accumulating evidence revealed that it also plays an important&#xD;
        role in pain modulation through multiple mechanisms. The investigators aimed to evaluate the&#xD;
        analgesic effect of melatonin during venous cannula insertion in preterm neonates by&#xD;
        assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the&#xD;
        procedure, and to demonstrate the significant relationship between procedural pain and&#xD;
        Malondialdehyde (MDA), a well-accepted marker of oxidative stress through measuring MDA after&#xD;
        60 minutes of the procedure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 20, 2022</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluate the analgesic effect of melatonin in preterm</measure>
      <time_frame>5 minutes starting just before cannula insertion to 5 minutes after the procedure</time_frame>
      <description>Evaluate the analgesic effect of melatonin during venous cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure.&#xD;
  Premature Infant pain Profile score (PIPP) scale 0-21, with 0-6 reflecting no pain, 6-12 reflecting mild-moderate pain, and above 12 indicating severe pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Malondialdehyde (MDA), marker of oxidative stress</measure>
      <time_frame>60 minutes of the procedure</time_frame>
      <description>Serum Malondialdehyde (MDA), a marker of oxidative stress through measuring serum MDA after 60 minutes of the procedure</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Preterm Neonate Analgesia</condition>
    <arm_group>
      <arm_group_label>Melatonin group</arm_group_label>
      <description>Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>Preterm neonates will undergo venous cannula insertion without giving melatonin before the procedure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Melatonin 10 mg</intervention_name>
      <description>Melatonin 10 mg will be used. 5 mg·kg-1 dissolved in 2 ml of distilled water via enteral route in one single dose 30 minutes before the venous cannula insertion</description>
      <arm_group_label>Melatonin group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood samples will be collected in plain tubes from peripheral veins. Samples will be allowed&#xD;
        to clot before centrifugation for 15 minutes and serum will be stored at (-20℃) until MDA&#xD;
        analysis using MDA competitive ELISA-kit. Collection of blood samples will be obtained 60&#xD;
        minutes after the procedure.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Stable preterm neonates born with a gestational age of less than 37 weeks who will have a&#xD;
          peripheral intravenous cannula insertion.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Preterm infant&#xD;
  &#xD;
            -  less than 37 weeks gestational age&#xD;
  &#xD;
            -  who started enteral feeding.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Multiple congenital anomalies.&#xD;
  &#xD;
            -  Facial malformation.&#xD;
  &#xD;
            -  Receiving analgesia or sedation.&#xD;
  &#xD;
            -  Contraindication of enteral feeding.&#xD;
  &#xD;
            -  Clinical or laboratory signs of sepsis.&#xD;
  &#xD;
            -  Infants with high oxygen needs either on invasive or non-invasive mechanical&#xD;
               ventilation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>28 Days</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hebatallah Shaaban, MD</last_name>
      <phone>01227169267</phone>
      <phone_ext>+20</phone_ext>
      <email>Heba_Ali@med.asu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Medicine - Ain Shams University</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Preterm</keyword>
    <keyword>Analgesia</keyword>
    <keyword>Melatonin</keyword>
    <keyword>Oxidative stress</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>Melatonin</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971485
  org study id: FMASU MS 496/2022
  nct id: NCT05971485
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with
        several important functions, including regulation of the circadian rhythms, and antioxidant
        and anti-inflammatory effects, accumulating evidence revealed that it also plays an important
        role in pain modulation through multiple mechanisms. The investigators aimed to evaluate the
        analgesic effect of melatonin during venous cannula insertion in preterm neonates by
        assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the
        procedure, and to demonstrate the significant relationship between procedural pain and
        Malondialdehyde (MDA), a well-accepted marker of oxidative stress through measuring MDA after
        60 minutes of the procedure.
  observational model: Case-Control
  time perspective: Prospective
  measure: Evaluate the analgesic effect of melatonin in preterm
  time frame: 5 minutes starting just before cannula insertion to 5 minutes after the procedure
  description: Evaluate the analgesic effect of melatonin during venous cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure.
  Premature Infant pain Profile score (PIPP) scale 0-21, with 0-6 reflecting no pain, 6-12 reflecting mild-moderate pain, and above 12 indicating severe pain
  measure: Malondialdehyde (MDA), marker of oxidative stress
  time frame: 60 minutes of the procedure
  description: Serum Malondialdehyde (MDA), a marker of oxidative stress through measuring serum MDA after 60 minutes of the procedure
  arm group label: Melatonin group
  description: Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion.
  arm group label: Control group
  description: Preterm neonates will undergo venous cannula insertion without giving melatonin before the procedure.
  intervention type: Drug
  intervention name: Melatonin 10 mg
  description: Melatonin 10 mg will be used. 5 mg·kg-1 dissolved in 2 ml of distilled water via enteral route in one single dose 30 minutes before the venous cannula insertion
  arm group label: Melatonin group
  Blood samples will be collected in plain tubes from peripheral veins. Samples will be allowed
        to clot before centrifugation for 15 minutes and serum will be stored at (-20℃) until MDA
        analysis using MDA competitive ELISA-kit. Collection of blood samples will be obtained 60
        minutes after the procedure.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 28 Days
  healthy volunteers: No
  last name: Hebatallah Shaaban, MD
  phone: 01227169267
  phone ext: +20
  email: Heba_Ali@med.asu.edu.eg
  facility: 
  status: Recruiting
  country: Egypt
  responsible party type: Sponsor
  mesh term: Premature Birth
  mesh term: Melatonin