<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/NCT04463927</url>
  </required_header>
  <id_info>
    <org_study_id>2020/2-16</org_study_id>
    <nct_id>NCT04463927</nct_id>
  </id_info>
  <brief_title>The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity</brief_title>
  <official_title>The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adiyaman University Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Adiyaman University Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: The aim of the study is to determine the effect of non-nutritive sucking on pain during&#xD;
      examination for retinopathy of prematurity.&#xD;
&#xD;
      Method: The study is conducted as a randomized controlled trial. The population of the study&#xD;
      is premature newborn who treatment in a neonatal intensive unit. The premature newborns&#xD;
      divided into two groups as an intervention and control group according to randomization.&#xD;
      After the randomization, non-nutritive sucking is applied to the intervention group. No&#xD;
      method is applied to the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A topical anesthetic will be applied to all premature newborns 30 seconds before eye&#xD;
      examination. Non-nutritive sucking is applied to the intervention group during the&#xD;
      examination for retinopathy of prematurity. No method is applied to the control group during&#xD;
      the examination for retinopathy of prematurity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2020</start_date>
  <completion_date type="Actual">October 9, 2020</completion_date>
  <primary_completion_date type="Actual">August 8, 2020</primary_completion_date>
  <phase>N/A</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</measure>
    <time_frame>1 minute</time_frame>
    <description>The primary outcome of the study is to evaluate the pain relief efficacy of non-nutritive sucking during examination for retinopathy of prematurity Premature Infant Pain Profile (PIPP).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The non-nutritive sucking is applied to the group during the examination for retinopathy of prematurity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The non-nutritive sucking is not applied to the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non-nutritive sucking</intervention_name>
    <description>intervention group received a sterile gloved finger during the examination for retinopathy of prematurity</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  having an examination for retinopathy of prematurity for the first time,&#xD;
&#xD;
          -  age was between 28-35 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - having no congenital anomalies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Weeks</minimum_age>
    <maximum_age>36 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tuba KOÇ ÖZKAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Adiyaman University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Adiyaman University</name>
      <address>
        <city>Adiyaman</city>
        <zip>02100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>August 7, 2021</last_update_submitted>
  <last_update_submitted_qc>August 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Adiyaman University</investigator_affiliation>
    <investigator_full_name>Tuba Koc Ozkan</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinopathy of Prematurity</mesh_term>
  </condition_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/NCT04463927
org study id: 2020/2-16
nct id: NCT04463927
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim: The aim of the study is to determine the effect of non-nutritive sucking on pain during
      examination for retinopathy of prematurity.

      Method: The study is conducted as a randomized controlled trial. The population of the study
      is premature newborn who treatment in a neonatal intensive unit. The premature newborns
      divided into two groups as an intervention and control group according to randomization.
      After the randomization, non-nutritive sucking is applied to the intervention group. No
      method is applied to the control group.
A topical anesthetic will be applied to all premature newborns 30 seconds before eye
      examination. Non-nutritive sucking is applied to the intervention group during the
      examination for retinopathy of prematurity. No method is applied to the control group during
      the examination for retinopathy of prematurity
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Premature Infant Pain Profile
time frame: 1 minute
description: The primary outcome of the study is to evaluate the pain relief efficacy of non-nutritive sucking during examination for retinopathy of prematurity Premature Infant Pain Profile (PIPP).
arm group label: Intervention Group
arm group type: Experimental
description: The non-nutritive sucking is applied to the group during the examination for retinopathy of prematurity
arm group label: Control Group
arm group type: No Intervention
description: The non-nutritive sucking is not applied to the control group.
intervention type: Other
intervention name: non-nutritive sucking
description: intervention group received a sterile gloved finger during the examination for retinopathy of prematurity
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 28 Weeks
maximum age: 36 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Tuba KOÇ ÖZKAN
role: Principal Investigator
affiliation: Adiyaman University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Adiyaman University
investigator full name: Tuba Koc Ozkan
investigator title: Assistant Professor
mesh term: Retinopathy of Prematurity
sharing ipd: No