<?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>IRCT2015081513691N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-11-13</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Kangaroo father care and it’s  effect  on father &amp; premature newborn cortisol  changes</public_title>
      <acronym></acronym>
      <scientific_title>Kangaroo father care and it’s  effect  on father &amp; premature newborn cortisol  changes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13480</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>stress.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, kangaroo care will be done after oral training and provide educational pamphlets to father. Infant is wearing only a diaper and cap will be in the fetal position or bending directly at skin to skin contact with father chest for an hour. For this purpose for the father would be considered a room in adjacent to the ward that the temperature is in the standard range and features such as bed and comfortable chair. Father embraces infant a quiet environment. Loose clothing that will be worn by a father, Infant will be protected, the creation of a fetal position or flexion for infant will be flexed to cause continuous coverage without creating pressure points or wrinkles and protect the infant from the air flow will be drawn a blanket over infant and father. In the intervention group, the distance of 5 minutes before and after the kangaroo intervention will be collected father blood sample and infant saliva sample to measure levels of cortisol. In the intervention group will be monitored heart rate, respiration, oxygen saturation and temperature throughout the study time for status monitoring and maintaining the stability of infant. Intervention 2: In the control group, routine usual cares will be carried out in the presence of father on infant and collect father blood sample and infant saliva sample will be performed before and after the duration of the study to assess the level of cortisol. In the control group, in addition to cortisol testing, CBC will be free to maintain the ethics of sampling.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arshadi Bostanabad Mohammad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, South Sharyati St</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 1479 6770</telephone>
        <email>arshadi@tbzmed.ac.ir; arshadi_m@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: premature infants 34-37 week; weight 1200-2500 grams; no heart failure and respiratory problems; apgar score in the fifth minute over than 7; non-sedating medicines; Non icteric; 24 hours after birth; one hour after any procedure and infant feeding; no defects in the pituitary - hypothalamic – adrenal and fathers literacy; proven lack of mental health problems; No disability of the in the implementation of care; the absence of renal and hepatic disease; Not taking medications such as: Corticosteroids, Spironolactone, Metoclopramide, Phenytoin and Morphine (from a week ago); Non-smoking and alcohol; No eating, drinking and strenuous physical activity (One hour before the sampling). Exclusion criteria: unstable respiratory condition and temperature; lack of parental consent for re-sampling; the reluctance of parents to continue the study; insufficient volume of sample.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post-traumatic stress disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, kangaroo care will be done after oral training and provide educational pamphlets to father. Infant is wearing only a diaper and cap will be in the fetal position or bending directly at skin to skin contact with father chest for an hour. For this purpose for the father would be considered a room in adjacent to the ward that the temperature is in the standard range and features such as bed and comfortable chair. Father embraces infant a quiet environment. Loose clothing that will be worn by a father, Infant will be protected, the creation of a fetal position or flexion for infant will be flexed to cause continuous coverage without creating pressure points or wrinkles and protect the infant from the air flow will be drawn a blanket over infant and father. In the intervention group, the distance of 5 minutes before and after the kangaroo intervention will be collected father blood sample and infant saliva sample to measure levels of cortisol. In the intervention group will be monitored heart rate, respiration, oxygen saturation and temperature throughout the study time for status monitoring and maintaining the stability of infant.</i_keyword>
      <i_keyword>In the control group, routine usual cares will be carried out in the presence of father on infant and collect father blood sample and infant saliva sample will be performed before and after the duration of the study to assess the level of cortisol. In the control group, in addition to cortisol testing, CBC will be free to maintain the ethics of sampling.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cortisol. Timepoint: 5 minutes before and 5 minutes after intervention. Method of measurement: ng/ml.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Neonatal heart rate. Timepoint: Every 15 minutes since the beginning of the intervention. Method of measurement: Pulse Oximeter.</sec_outcome>
      <sec_outcome>Neonatal breath. Timepoint: Every 15 minutes since the beginning of the intervention. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Neonatal Arterial blood oxygen saturation. Timepoint: Every 15 minutes since the beginning of the intervention. Method of measurement: Pulse Oximeter.</sec_outcome>
      <sec_outcome>Neonatal body temperature. Timepoint: Every 15 minutes since the beginning of the intervention. Method of measurement: Thermometer.</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>Vice chancellor for research, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-02</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research Vice-Chancellor, Floor 3, No 2 Central Building, Tabriz University of Medical Sciences, University Street Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
