<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20241123063810N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-12-15</date_registration>
      <primary_sponsor>College of Nursing, University of Baghdad</primary_sponsor>
      <public_title>Pediatric Phlebitis In pediatric Wards</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Intravenous House Ultra Dressing in Reducing Pediatric Phlebitis In pediatric Wards :A randomized controlled trial (RCT)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80580</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Tools used in randomization such as table of random numbers, computer softwares, etc.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Phlebitis  management-related intravenous cannulation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After obtaining the patient's consent and explaining the use of the IV House UltraDressing, the dressing is applied over the IV cannula site immediately after cannulation. The dressing is secured according to the manufacturer's instructions. The researcher assesses the cannula site for signs of phlebitis daily for three days using the Visual Infusion Phlebitis (VIP) scale. Intervention 2: Control group: The intravenous catheter was inserted using the hospital's standard dressing without any intervention or application by the researcher. The nurse assisting the researcher in the pediatric ward performed the standard procedure, and the researcher assessed phlebitis daily for three days using the Visual Infusion Phlebitis (VIP) scale.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals

When:
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications

To whom:
All the related files will be shared with any scientific interested parties.

Conditions:
It may be used after seeking the author's permission and acknowledging his contribution.

Where to obtain:
The author's professional email, which will be available with the published manuscript, can be used to contact the author. e-Mail:ruaa.abd2304m@conursing.uobaghdad.edu.iq

How to obtain:
N/A

Comments:
The IRCT members deserve sincere gratitude for their sincere efforts to support researchers in achieving their academic goals.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roaa Qaseem Mohammed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Celebration Strees</address>
        <city>Tikrit</city>
        <country1>Iraq</country1>
        <zip>34011</zip>
        <telephone>+964 781 862 5817</telephone>
        <email>ruaa.abd2304m@conursing.uobaghdad.edu.iq</email>
        <affiliation>College of Nursing, University of Baghdad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roaa Qaseem Mohammed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Celebration Strees</address>
        <city>Tikrit</city>
        <country1>Iraq</country1>
        <zip>34011</zip>
        <telephone>+964 781 862 5817</telephone>
        <email>ruaa.abd2304m@conursing.uobaghdad.edu.iq</email>
        <affiliation>College of Nursing, University of Baghdad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Pediatric patient aged 2 months to 3 years.
2. Patient with IV catheter dwell time exceeding 48 hours.
3. Intravenous therapy.</inclusion_criteria>
      <agemin>2 months</agemin>
      <agemax>3 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Patients with existing phlebitis or skin infections.
2. Patient with known allergies or reaction to the material used in the ultra-dressing.
3. Pediatric patients older than 3 years.
4. Patients with chronic vascular or immune system conditions that could influence the development of phlebitis.
ents with IV catheters for less than 48 hours.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After obtaining the patient's consent and explaining the use of the IV House UltraDressing, the dressing is applied over the IV cannula site immediately after cannulation. The dressing is secured according to the manufacturer's instructions. The researcher assesses the cannula site for signs of phlebitis daily for three days using the Visual Infusion Phlebitis (VIP) scale.</i_keyword>
      <i_keyword>Control group: The intravenous catheter was inserted using the hospital's standard dressing without any intervention or application by the researcher. The nurse assisting the researcher in the pediatric ward performed the standard procedure, and the researcher assessed phlebitis daily for three days using the Visual Infusion Phlebitis (VIP) scale.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reducing phlebitis in pediatrics. Timepoint: The patient's response is assessed for phlebitis within three days of applying the intravenous cannula dressing. Method of measurement: Phlebitis is assessed in pediatrics using the Visual Infusion Phlebitis Scale (VIPS) to assess phlebitis severity. within three days of applying the intervenous cannula dressing.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The author of the trial is the funding source</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-06</approval_date>
        <contact_name>Research Ethical Approval Committee, at the College of Nursing</contact_name>
        <contact_address>Celebration Strees Tikrit Salah din Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
