<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/NCT02195661</url>
  </required_header>
  <id_info>
    <org_study_id>070/2014</org_study_id>
    <nct_id>NCT02195661</nct_id>
  </id_info>
  <brief_title>The Role of Melatonin in the Effective Attainment of Sleep Electroencephalograms (EEG) in Children</brief_title>
  <official_title>The Role of Melatonin in the Effective Attainment of Sleep Electroencephalograms (EEG) in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cape Town</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine the safety and effectiveness of oral melatonin as natural&#xD;
      inducer of sleep to acquire useful EEGs in South African children following its introduction&#xD;
      as the main agent used in the Neurophysiology department at Red Cross Children's Hospital.&#xD;
      This is an observational retrospective study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of melatonin to induce sleep for EEG studies</measure>
    <time_frame>6 months</time_frame>
    <description>Successful attainment of EEG (in comparison to the unit's previous success rate)(Definition: &quot;successful attainment of EEG&quot; = completed sleep EEG, without excessive artefact enabling an comprehensive report to be generated in a child who undergoes the procedure without evidence of adverse drug reactions)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breakdown data from the successful EEGs -</measure>
    <time_frame>6 months</time_frame>
    <description>Yield in terms of EEG abnormalities - number of abnormal studies, number of studies yielding outcomes which will alter patient management</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Comparison of EEGs performed under melatonin sedation compared to previous unit protocol</measure>
    <time_frame>6 months</time_frame>
    <description>To compare the EEG recordings in comparison to a historical group of age matched recordings sedated with chloral and to establish if the outcomes achieved are in line with the previous unit practice.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">194</enrollment>
  <condition>Epilepsy</condition>
  <condition>Electroencephalogram</condition>
  <condition>Children</condition>
  <condition>Sedation</condition>
  <arm_group>
    <arm_group_label>Melatonin sleep EEG induced group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All children who were referred to the neurophysiology department who were either unable to keep still for their EEG, or required a sleep EEG as part of their epilepsy &quot;work-up&quot; and whose caregivers agreed to the administering of sedation with melatonin. Melatonin by mouth (3mg for children &lt; 15kg, 6mg for those &gt; 15kg) 1 hour before the scheduled EEG by the unit nurse. Children who can swallow the capsules directly, those who cannot are given the contents of the powder in the capsule mixed in a few millilitres of water. If the child fails to fall asleep within one hour of administration of the melatonin then a second dose 3mg is given) .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison group for children sedated using previous practice</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Since the choral hydrate had been withdrawn a direct comparison group was not possible. However a study performed the previous year in the department measured a several parallel useful outcomes. This study had addressed the usefulness of electroencephalograms in a South African population. A proportion of this group screened in 2012 in our unit underwent sleep studies, sedated with chloral (n=22). These patients were drawn from the same regional pool, with the same disease demographics, and the same sleep deprivation and procedural techniques to the current group. This group was screened for several common denominators to the current study themes, and comparison will be made between these, namely the proportion of patients with successful attainment of sleep studies, the proportion of studies with excessive artifact (precluding interpretation) and the usefulness of the data attained detailing whether the studies were able to assist or alter patient management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Melatonin</intervention_name>
    <arm_group_label>Melatonin sleep EEG induced group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chloral Hydrate</intervention_name>
    <arm_group_label>Comparison group for children sedated using previous practice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All children who were referred to the neurophysiology department who were either&#xD;
             unable to keep still for their EEG, or required a sleep EEG as part of their epilepsy&#xD;
             &quot;work-up&quot; and whose caregivers agreed to the administering of sedation with melatonin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those children undergoing prolonged EEG monitoring (telemetry) or within 24 hours of&#xD;
             status epilepticus (prolonged or cluster of seizures).&#xD;
&#xD;
          -  Those children are not sedated as natural sleep is always attained with the prolonged&#xD;
             monitoring studies, and for those with status epilepticus, there is usually evidence&#xD;
             on the EEG of alteration secondary to the effects of status, and the medications&#xD;
             administered to control the presenting event.&#xD;
&#xD;
          -  Any child deemed to unwell to undergo a non-emergency procedure.&#xD;
&#xD;
          -  Any child already receiving anticoagulant medications.&#xD;
&#xD;
          -  Any caregiver who deferred sedation for their child was also excluded from the study&#xD;
             and in the unit the procedure attempted without sedation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Red Cross War Memorial Children's Hospital</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7700</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <reference>
    <citation>Ibekwe R, Jeaven L, Wilmshurst JM. The role of melatonin to attain electroencephalograms in children in a sub-Saharan African setting. Seizure. 2017 Oct;51:87-94. doi: 10.1016/j.seizure.2017.08.002. Epub 2017 Aug 12.</citation>
    <PMID>28826048</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>November 28, 2017</last_update_submitted>
  <last_update_submitted_qc>November 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cape Town</investigator_affiliation>
    <investigator_full_name>Jo M Wilmshurst</investigator_full_name>
    <investigator_title>Professor Jo Wilmshurst</investigator_title>
  </responsible_party>
  <keyword>Epilepsy</keyword>
  <keyword>Electroencephalogram</keyword>
  <keyword>children</keyword>
  <keyword>sedation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
    <mesh_term>Chloral Hydrate</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/NCT02195661
org study id: 070/2014
nct id: NCT02195661
lead sponsor: 
has dmc: Yes
This study aims to determine the safety and effectiveness of oral melatonin as natural
      inducer of sleep to acquire useful EEGs in South African children following its introduction
      as the main agent used in the Neurophysiology department at Red Cross Children's Hospital.
      This is an observational retrospective study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Efficacy of melatonin to induce sleep for EEG studies
time frame: 6 months
description: Successful attainment of EEG (in comparison to the unit's previous success rate)(Definition: "successful attainment of EEG" = completed sleep EEG, without excessive artefact enabling an comprehensive report to be generated in a child who undergoes the procedure without evidence of adverse drug reactions)
measure: Breakdown data from the successful EEGs -
time frame: 6 months
description: Yield in terms of EEG abnormalities - number of abnormal studies, number of studies yielding outcomes which will alter patient management
measure: Comparison of EEGs performed under melatonin sedation compared to previous unit protocol
time frame: 6 months
description: To compare the EEG recordings in comparison to a historical group of age matched recordings sedated with chloral and to establish if the outcomes achieved are in line with the previous unit practice.
arm group label: Melatonin sleep EEG induced group
arm group type: Active Comparator
description: All children who were referred to the neurophysiology department who were either unable to keep still for their EEG, or required a sleep EEG as part of their epilepsy "work-up" and whose caregivers agreed to the administering of sedation with melatonin. Melatonin by mouth (3mg for children < 15kg, 6mg for those > 15kg) 1 hour before the scheduled EEG by the unit nurse. Children who can swallow the capsules directly, those who cannot are given the contents of the powder in the capsule mixed in a few millilitres of water. If the child fails to fall asleep within one hour of administration of the melatonin then a second dose 3mg is given) .
arm group label: Comparison group for children sedated using previous practice
arm group type: Other
description: Since the choral hydrate had been withdrawn a direct comparison group was not possible. However a study performed the previous year in the department measured a several parallel useful outcomes. This study had addressed the usefulness of electroencephalograms in a South African population. A proportion of this group screened in 2012 in our unit underwent sleep studies, sedated with chloral (n=22). These patients were drawn from the same regional pool, with the same disease demographics, and the same sleep deprivation and procedural techniques to the current group. This group was screened for several common denominators to the current study themes, and comparison will be made between these, namely the proportion of patients with successful attainment of sleep studies, the proportion of studies with excessive artifact (precluding interpretation) and the usefulness of the data attained detailing whether the studies were able to assist or alter patient management.
intervention type: Dietary Supplement
intervention name: Melatonin
arm group label: Melatonin sleep EEG induced group
intervention type: Drug
intervention name: Chloral Hydrate
arm group label: Comparison group for children sedated using previous practice
criteria: 
gender: All
minimum age: 6 Months
maximum age: 13 Years
healthy volunteers: No
facility: 
country: South Africa
citation: Ibekwe R, Jeaven L, Wilmshurst JM. The role of melatonin to attain electroencephalograms in children in a sub-Saharan African setting. Seizure. 2017 Oct;51:87-94. doi: 10.1016/j.seizure.2017.08.002. Epub 2017 Aug 12.
PMID: 28826048
responsible party type: Principal Investigator
investigator affiliation: University of Cape Town
investigator full name: Jo M Wilmshurst
investigator title: Professor Jo Wilmshurst
mesh term: Epilepsy
mesh term: Melatonin
mesh term: Chloral Hydrate