<?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>IRCT20100823004617N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-03</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Caring Program in Prevention of  Diaper Dermatitis in Infants</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Caring Program in Prevention of  Diaper Dermatitis in Hospitalized Infants: Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52570</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using Rand List software, through blocks of 4 and 6, they will be randomly divided into two groups of intervention and control (control group = A and intervention group = B). The random sequence created will be covered using allocation envelopes (Allocation concealment) and the envelopes will be given to the executive nurse in order of number. After opening the envelope, the type of baby group will be determined, Blinding description: The outcome of the study, Incidence, severity and extent dermatitis, which will be measured daily with the help of a researcher who is not aware of the infant being assigned to study groups., and so, The data analyzer will not know how to assign groups to study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diaper Dermatitis.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: In the intervention group, the caring plan will be taught theoretically and practically (face to face) to mothers by the researcher in a one-hour session in the infant's bedside. This plan will be implemented in five parts. First, basic training on skin care is given, then how to use diaper, including when and how to change it. In the third part, instructions on how to clean the diaper area and in the fourth part, the use of protective creams are presented, at the end, the symptoms of dermatitis and related care will be taught. From the first day of hospitalization until discharge (for at least 5 days), the mother will do this caring plan, and the researcher will monitor how it is implemented and provide corrective feedback to the mother if needed. The educational items will be provided to mothers in the form of a pamphlet. Intervention 2: Control group: In this group, routine care will be performed. In the routine care, the mothers learns how to clean the diaper area. In this training, mothers are advised to clean the diaper area with water-soaked cotton after each defecation and use zinc oxide ointment if the skin becomes red. After completing the study, an educational pamphlet will be provided to the mothers of the control group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is "No more information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Jabraeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery., Shariati Street., Tabriz.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>jabraeilim@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Jabraeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery., Shariati Street., Tabriz.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>jabraeilim@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The infant is less than 28 days old.
The infant weighs between 2.5 and 4 kg.
Feed the infant with breast milk.
The infant's mother should be by his side constantly.</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>28 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If the infant has diaper dermatitis at the beginning of the study.
The infant has congenital diabetes.
If the mother does not want to continue studying.
The infant has a congenital skin disease.
The infant should receive immunosuppressive drugs.
Infants admitted with a diagnosis of sepsis.
The infant has known known drug and food allergies.
The mother of the infant should not follow the care plan.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L22</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diaper dermatitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: In the intervention group, the caring plan will be taught theoretically and practically (face to face) to mothers by the researcher in a one-hour session in the infant's bedside. This plan will be implemented in five parts. First, basic training on skin care is given, then how to use diaper, including when and how to change it. In the third part, instructions on how to clean the diaper area and in the fourth part, the use of protective creams are presented, at the end, the symptoms of dermatitis and related care will be taught. From the first day of hospitalization until discharge (for at least 5 days), the mother will do this caring plan, and the researcher will monitor how it is implemented and provide corrective feedback to the mother if needed. The educational items will be provided to mothers in the form of a pamphlet.</i_keyword>
      <i_keyword>Control group: In this group, routine care will be performed. In the routine care, the mothers learns how to clean the diaper area. In this training, mothers are advised to clean the diaper area with water-soaked cotton after each defecation and use zinc oxide ointment if the skin becomes red. After completing the study, an educational pamphlet will be provided to the mothers of the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"Percentage of infants with dermatitis". Timepoint: "The effect of care program on dermatitis prevention" Measuring the incidence, extent and severity of dermatitis up to 5 days after the intervention. Method of measurement: "Assess infant skin through observation".</prim_outcome>
      <prim_outcome>"Measuring the extent of diaper dermatitis". Timepoint: "Daily for 5 days". Method of measurement: "Using dermatitis extent scale designed by Dabirian (1999)".</prim_outcome>
      <prim_outcome>"Measuring the severity of diaper dermatitis". Timepoint: "Daily for 5 days". Method of measurement: "Measurement of dermatitis severity using the 2005 Al Waili five-point scale".</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-25</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery., Shariati Sreeet., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
