<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/NCT04458441</url>
  </required_header>
  <id_info>
    <org_study_id>1001</org_study_id>
    <nct_id>NCT04458441</nct_id>
  </id_info>
  <brief_title>Can Warm Skin Disinfection Reduce the Pain Peripheral Central Catheter Application in Premature Babies?</brief_title>
  <acronym>w-pi</acronym>
  <official_title>Does Warm Skin Disinfection Reduce the Pain Score or Increase the Application Success in Peripheral Central Catheter Application in Premature Babies?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zekai Tahir Burak Women's Health Research and Education Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zekai Tahir Burak Women's Health Research and Education Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Peripheral central catheter application, especially in extremely low birth weight premature&#xD;
      babies, is an intensive care follow-up procedure. There are many clinical studies in areas&#xD;
      such as catheter type, skin disinfection, catheter duration, catheter infection. In our&#xD;
      practice, it was observed that premature baby was less uncomfortable, the number of trials&#xD;
      decreased, and the change in body temperature was less with the application of hot skin&#xD;
      disinfection in our practice. With a prospective randomized study, the investigators wanted&#xD;
      to document their observational data scientifically.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Babies under 32 gestation week and 1250 g who are treated at level 3 NICU and need peripheral&#xD;
      central catheter will be included in the study. In the preparation of peripheral central&#xD;
      catheter application, skin cleaning is performed with povidone iodine in our clinic. The&#xD;
      investigators used during the povidione iodine preparation phase after heating the bain-marie&#xD;
      method with sterile conditions. The investigators predicted that the premature baby would&#xD;
      have less discomfort with warm povidion iodine. To demonstrate this, it was planned to take&#xD;
      both video recordings during the application and N-PASS evaluation by an experienced person&#xD;
      who does not know the povidone iodine temperature used .In preparation of the catheter except&#xD;
      the person who did povidone iodine skin cleansing, nobody knows the heat. The catheters were&#xD;
      administered by a single experienced person. The study was designed to be unaware of the&#xD;
      povidin iodine application temperature of the person applying the catheter and the N-PASS&#xD;
      assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 5, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 5, 2022</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>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change feeling of pain and restlessness in premature</measure>
    <time_frame>every 10 seconds before the 5 minutes and during the procedure</time_frame>
    <description>Evaluation of pain score in the patient during the procedure with n-pass evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>protection of body temperature</measure>
    <time_frame>before 5 min, during procedure</time_frame>
    <description>body temperature monitoring before and during the incubator with skin temperature probe</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pain, Acute</condition>
  <condition>Premature</condition>
  <arm_group>
    <arm_group_label>warm skin desenfection group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Povidion iodine will be used as a skin cleanser. povidion iodine will be heated sterile to 38 degrees with a ben-mari method and its temperature will be controlled by degrees. When it reaches the appropriate degree, the skin cleaning of the baby will be done sterile.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cold skin desenfection group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Povidion iodine will be used as a skin cleanser. povidion iodine will be used in the skin cleaning of the baby without any heating procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>warm group/cold group</intervention_name>
    <description>sequential randomization</description>
    <arm_group_label>warm skin desenfection group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: below 32 gestational weeks and / or 1250 grams preterm babies neonates&#xD;
        requiring total parenteral nutrition, antibiotic therapy for at least 7 days, -&#xD;
&#xD;
        Exclusion Criteria: major congenital anomalilies refusal to sign consent patient with&#xD;
        previously attemped or placed central lines&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Month</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>funda atay</last_name>
    <phone>+905054409167</phone>
    <email>funday.atay@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Health Sciences Istanbul Umraniye Teaching Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>funda atay</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>March 6, 2022</last_update_submitted>
  <last_update_submitted_qc>March 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zekai Tahir Burak Women's Health Research and Education Hospital</investigator_affiliation>
    <investigator_full_name>Funda Yavanoglu Atay</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>premature, pain score, Picc line</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Acute Pain</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/NCT04458441
org study id: 1001
nct id: NCT04458441
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Peripheral central catheter application, especially in extremely low birth weight premature
      babies, is an intensive care follow-up procedure. There are many clinical studies in areas
      such as catheter type, skin disinfection, catheter duration, catheter infection. In our
      practice, it was observed that premature baby was less uncomfortable, the number of trials
      decreased, and the change in body temperature was less with the application of hot skin
      disinfection in our practice. With a prospective randomized study, the investigators wanted
      to document their observational data scientifically.
Babies under 32 gestation week and 1250 g who are treated at level 3 NICU and need peripheral
      central catheter will be included in the study. In the preparation of peripheral central
      catheter application, skin cleaning is performed with povidone iodine in our clinic. The
      investigators used during the povidione iodine preparation phase after heating the bain-marie
      method with sterile conditions. The investigators predicted that the premature baby would
      have less discomfort with warm povidion iodine. To demonstrate this, it was planned to take
      both video recordings during the application and N-PASS evaluation by an experienced person
      who does not know the povidone iodine temperature used .In preparation of the catheter except
      the person who did povidone iodine skin cleansing, nobody knows the heat. The catheters were
      administered by a single experienced person. The study was designed to be unaware of the
      povidin iodine application temperature of the person applying the catheter and the N-PASS
      assessment.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Double (Care Provider, Investigator)
measure: change feeling of pain and restlessness in premature
time frame: every 10 seconds before the 5 minutes and during the procedure
description: Evaluation of pain score in the patient during the procedure with n-pass evaluation
measure: protection of body temperature
time frame: before 5 min, during procedure
description: body temperature monitoring before and during the incubator with skin temperature probe
arm group label: warm skin desenfection group
arm group type: Active Comparator
description: Povidion iodine will be used as a skin cleanser. povidion iodine will be heated sterile to 38 degrees with a ben-mari method and its temperature will be controlled by degrees. When it reaches the appropriate degree, the skin cleaning of the baby will be done sterile.
arm group label: cold skin desenfection group
arm group type: No Intervention
description: Povidion iodine will be used as a skin cleanser. povidion iodine will be used in the skin cleaning of the baby without any heating procedure.
intervention type: Other
intervention name: warm group/cold group
description: sequential randomization
arm group label: warm skin desenfection group
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Month
healthy volunteers: No
last name: funda atay
phone: +905054409167
email: funday.atay@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
investigator full name: Funda Yavanoglu Atay
investigator title: principal investigator
mesh term: Premature Birth
mesh term: Acute Pain
sharing ipd: No