<?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>IRCT201110037697N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-09-16</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Lorestan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of skin to skin contact mother and newborn on temperature and breastfeeding in newborns after cesarean delivery.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between the effect of skin to skin contact mother and newborn and routine care on temperature and breastfeeding successfulness in full term newborns after cesarean delivery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8160</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Randomization will be done by using of random numbers table and closed envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Temperature of newborn. Condition 2: Breastfeeding.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After the mother’s cesarean delivery and her transfer to the ward, the naked newborn, in prone position, will be placed between the mother’s breasts for skin to skin contact with her. To avoid heat wastage, the newborn’s head will be covered with a hat and his / her back will be covered with a blanket. The mother's and newborn’s temperatures will be measured immediately after skin to skin contact and every half hour for one hour with IN4 model infrared ray thermometer on the forehead. Also, Infant Breastfeeding Assessment Tool (IBAT) will be used to measure infants’ success in breastfeeding; which includes four subscales: Readiness to feed, rooting reflex, latching on to the breast and sucking reflex. Each subscale has 0-3 scores and the total score ranges from 0-12. Intervention 2: Control group: After the mother’s cesarean delivery and her transfer to the ward, the dressed newborn will be placed in the bassinet or in the mother’s bed as a hospital usual method. The mother's and newborn’s temperatures will be measured when newborn handed to her mother and every half hour for one hour with IN4 model infrared ray thermometer on the forehead. Also, Infant Breastfeeding Assessment Tool (IBAT) will be used to measure infants’ success in breastfeeding; which includes four subscales: Readiness to feed, rooting reflex, latching on to the breast and sucking reflex. Each subscale has 0-3 scores and the total score ranges from 0-12.</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>Shourangiz Beiranvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Nursing and Midwifery Faculty, Lorestan University of Medical Sciences, Kamalvand</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381351698</zip>
        <telephone>+98 66 1620 0140</telephone>
        <email>shorangizbiranvand@yahoo.com;   shorangiz.beiranvand@lums.ac.ir</email>
        <affiliation>Lorestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for mothers: Age of 18-36 years old, singleton pregnancy, non - emergency cesarean delivery with spinal anesthesia and gestational age of 38-42 weeks. &#13;
Inclusion criteria for newborns: Full term, Maximum age of newborns 4 hours after birth (One - day newborn), newborns' birth weight of more than 2500 gram and first and fifth minute Apgar score of more than seven. &#13;
Exclusion criteria for mothers: Any medical problems in mothers after surgery &#13;
 Exclusion criteria for newborns: Any medical problems in newborns which can disrupt skin to skin contact and breastfeeding</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>1 year</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P80.8</hc_code>
      <hc_code>P92.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other hypothermia of newborn</hc_keyword>
      <hc_keyword>Neonatal difficulty in feeding at breast</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: After the mother’s cesarean delivery and her transfer to the ward, the naked newborn, in prone position, will be placed between the mother’s breasts for skin to skin contact with her. To avoid heat wastage, the newborn’s head will be covered with a hat and his / her back will be covered with a blanket. The mother's and newborn’s temperatures will be measured immediately after skin to skin contact and every half hour for one hour with IN4 model infrared ray thermometer on the forehead. Also, Infant Breastfeeding Assessment Tool (IBAT) will be used to measure infants’ success in breastfeeding; which includes four subscales: Readiness to feed, rooting reflex, latching on to the breast and sucking reflex. Each subscale has 0-3 scores and the total score ranges from 0-12.</i_keyword>
      <i_keyword>Control group: After the mother’s cesarean delivery and her transfer to the ward, the dressed newborn will be placed in the bassinet or in the mother’s bed as a hospital usual method. The mother's and newborn’s temperatures will be measured when newborn handed to her mother and every half hour for one hour with IN4 model infrared ray thermometer on the forehead. Also, Infant Breastfeeding Assessment Tool (IBAT) will be used to measure infants’ success in breastfeeding; which includes four subscales: Readiness to feed, rooting reflex, latching on to the breast and sucking reflex. Each subscale has 0-3 scores and the total score ranges from 0-12.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Temperature of Newborns. Timepoint: Before and immediately after intervention and every half hour for one hour during intervention. Method of measurement: Infrared ray thermometer on the forehead, IN4 model.</prim_outcome>
      <prim_outcome>Infants' breastfeeding status. Timepoint: During intervention for one hour. Method of measurement: Standard questionnaire of the Infant Breastfeeding Assessment Tool (IBAT).</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>Vice Chancellor for Research of Lorestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-05-12</approval_date>
        <contact_name>Ethics Committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Department of Research and Technology, Lorestan University of Medical Sciences, Kamalvand Khorramabad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
