<?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>IRCT20181024041451N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-17</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effects of Kangaroo Mother Care education intervention on the Premature Infants</public_title>
      <acronym></acronym>
      <scientific_title>The effects of Kangaroo Mother Care education intervention on the Premature Infants based on expanded health belief model : Shahid Sadoughi hospital ٬Yazd</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>124</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35845</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: One of the strengths of this study was its exploratory approach to the design of the research instrument. By measuring CVI and CVRs, an attempt was made to develop an adapted valid and reliable instrument to the conditions of the study population to objectively reflect mothers' perceptions;.</study_design>
      <phase>N/A</phase>
      <hc_freetext>premature infants.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to routine hospital training, mothers with preterm infants also receive Kangaroo Care Education based on the Expanded Health Belief Model. Intervention 2: Control group: Only receive routine hospital training.</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:
Given the preparation of the article for the publication of scientific journals, individual data of unidentified samples will be available to reputable journals.

When:
3 months after the publication of the article, information will be provided to individuals upon request.

To whom:
Only those who are busy at university centers will have access.

Conditions:
There are no other conditions to correspond with the author.

Where to obtain:
Author responsible by email

How to obtain:
After submitting the application on average after one to two weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sedighe Safari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi University of Medical Sciences,Shohadaye gomnam Blvd,Alem Square</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>891517316</zip>
        <telephone>+98 35 3820 9100</telephone>
        <email>se.safari71@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hosseinali Sadeghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi University of Medical Sciences,Shohadaye gomnam Blvd,Alem Square</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>891517316</zip>
        <telephone>+98 35 3820 9100</telephone>
        <email>sadeghian.hossein@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The gestational age is less than and equal to 32 weeks
the birth weight is less than and equal to 1800 grams
the cardiovascular condition is stable</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to routine hospital training, mothers with preterm infants also receive Kangaroo Care Education based on the Expanded Health Belief Model.</i_keyword>
      <i_keyword>Control group: Only receive routine hospital training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mother's perceived sensitivity score. Timepoint: Before starting kangaroo care and time to discharge the baby. Method of measurement: Researcher-made questionnaire based on expanded health belief model.</prim_outcome>
      <prim_outcome>Mother's perceived intensity score. Timepoint: Before starting kangaroo care and time to discharge the baby. Method of measurement: Researcher-made questionnaire based on expanded health belief model.</prim_outcome>
      <prim_outcome>Mother's perceived benefit score. Timepoint: Before starting kangaroo care and time to discharge the baby. Method of measurement: Researcher-made questionnaire based on expanded health belief model.</prim_outcome>
      <prim_outcome>The score of the perceived barriers of the mother. Timepoint: Before starting kangaroo care and time to discharge the baby. Method of measurement: Researcher-made questionnaire based on expanded health belief model.</prim_outcome>
      <prim_outcome>The score of the Cues to action of the mother. Timepoint: Before starting kangaroo care and time to discharge the baby. Method of measurement: Researcher-made questionnaire based on expanded health belief model.</prim_outcome>
      <prim_outcome>Mother's self-efficacy score. Timepoint: Before starting kangaroo care and time to discharge the baby. Method of measurement: Researcher-made questionnaire based on expanded health belief model.</prim_outcome>
      <prim_outcome>Mother's perceived social support score. Timepoint: Before starting kangaroo care and time to discharge the baby. Method of measurement: Researcher-made questionnaire based on expanded health belief model.</prim_outcome>
      <prim_outcome>Mother's Locus of control score. Timepoint: Before starting kangaroo care and time to discharge the baby. Method of measurement: Researcher-made questionnaire based on expanded health belief model.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight of baby discharge time. Timepoint: At the time of discharge the baby. Method of measurement: Using Digital Scales.</sec_outcome>
      <sec_outcome>The duration of oxygen therapy. Timepoint: At the time of discharge the baby. Method of measurement: Use of a baby's treatment file - The number of days the baby has received supplemental oxygen in any form.</sec_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: At the time of discharge the baby. Method of measurement: The sum of the days when the baby was admitted to the NICU due to complications of prematurity.</sec_outcome>
      <sec_outcome>Retinopathy. Timepoint: At the time of discharge the baby. Method of measurement: Use of a baby's treatment file.</sec_outcome>
      <sec_outcome>The death of babies. Timepoint: At the time of discharge the baby. Method of measurement: Whether or not a baby is alive.</sec_outcome>
      <sec_outcome>Average baby's weight gain per day. Timepoint: Daily. Method of measurement: Using Digital Scales.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-03</approval_date>
        <contact_name>Ethics committee of shahid Sadoughi University of Medical Sciences in Yazd</contact_name>
        <contact_address>School of Public Health, shahid Sadoughi University of Medical Sciences, Gomnam Shahid Blvd,Alem Square Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
