<?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>IRCT201506064617N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-09-16</date_registration>
      <primary_sponsor>Deputy of research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of kangaroo mother care on the level of bilirubin in the newborn after cesarean and maternal satisfaction from care after birth</public_title>
      <acronym></acronym>
      <scientific_title>Effects of kangaroo mother care on the level of bilirubin in the newborn after cesarean and maternal satisfaction from care after birth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>116</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4953</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: This study will done with random selection. Assigned acts to the mothers will be done in admission time with use of number opaque sealed envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Kangaroo mother care.</hc_freetext>
      <i_freetext>Intervention 1: The control group  after mother exit of the operating room will be receive routine care in recovery room.  Newborns baseline bilirubin will controlled through forehead skin after birth with Billy Check (K-J-8000 model, made in China). Twenty-four and thirty-six hours  and  fifth day after birth neonatal bilirubin  will be control and recorded again.On the third day postpartum mothers' satisfaction will be measured through  questionnaires. Intervention 2: The intervention group before mothers transfer to the operating room will be trained about kangaroo mother care for 30 minutes. Newborns baseline bilirubin will controlled through forehead skin after birth with Billy Check (K-J-8000 model, made in China). The this group babies will be placed between mother's breasts immediately after birth in the recovery room. With blanket will be kept warm and dry, and a hat will be placed on baby's head to prevent heat loss. Appropriate position will be given to mother with folding bed or pillows. Kangaroo mother care will continue for 30 minutes. This position will be continued time mother transfer to surgery ward. Kangaroo mother care will be continued in the ward after transfer three times a day, each time for 30 minutes at hours 7, 13 and 19 until discharge. Curtain will help to privacy during kangaroo mother care. The baby's bilirubin will be controlled with Billy Check from forehead skin at hours 24, 36 after birth and fifth day, and will be recorded. Two questionnaires will be giving to the mothers on the third day. Maternal satisfaction  from postpartum care and their experiences of kangaroo care will be measured on the third day after birth.</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>Seyyedrasooly Alehe</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Shariati South Street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9775138947</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>seyyedrasooly@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jabraeili Mahnaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Shariati South Street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9775138947</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>jebreilim@yahoo.com; Jabraeilim@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria newborns: infants born by cesarean delivery with spinal anesthesia; neonates (37 to 40 weeks of gestation); the apgar score birth fifth minute above 7. Inclusion criteria mothers: mothers of term infants; literate mothers; mothers are alert and awake; mothers receive spinal anesthesia. Exclusion criteria newborns: during the study, infants with respiratory distress or other problems; If, after the arrival newborn to the study inclusion criteria was not been observed; the newborn discharge during the study with parents satisfaction; pathologic jaundice factors (incompatibilities ABO-RH) or aggravating factors (deficiency glucose six phosphate dehydrogenase); cephalohematoma or significant contusion; respiratory distress syndrome or any condition that prevents of the delivery of newborn to mother; having a baby's skin disease; congenital anomalies; life-threatening problems; newborn alcohol syndrome. Exclusion criteria mothers: if the mothers does not want  continued the study; after random selection of mothers in the control group was insisted to be in the  intervention group; use psychotropic antidepressants, cigarette or other drugs; having previous experience of kangaroo mother care, study or employment mother in the field of medical sciences; mother's skin disease; having diabetes or hypertension; mother received general anesthesia.</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>5 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z39.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Care and examination immediately after delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group  after mother exit of the operating room will be receive routine care in recovery room.  Newborns baseline bilirubin will controlled through forehead skin after birth with Billy Check (K-J-8000 model, made in China). Twenty-four and thirty-six hours  and  fifth day after birth neonatal bilirubin  will be control and recorded again.On the third day postpartum mothers' satisfaction will be measured through  questionnaires</i_keyword>
      <i_keyword>The intervention group before mothers transfer to the operating room will be trained about kangaroo mother care for 30 minutes. Newborns baseline bilirubin will controlled through forehead skin after birth with Billy Check (K-J-8000 model, made in China). The this group babies will be placed between mother's breasts immediately after birth in the recovery room. With blanket will be kept warm and dry, and a hat will be placed on baby's head to prevent heat loss. Appropriate position will be given to mother with folding bed or pillows. Kangaroo mother care will continue for 30 minutes. This position will be continued time mother transfer to surgery ward. Kangaroo mother care will be continued in the ward after transfer three times a day, each time for 30 minutes at hours 7, 13 and 19 until discharge. Curtain will help to privacy during kangaroo mother care. The baby's bilirubin will be controlled with Billy Check from forehead skin at hours 24, 36 after birth and fifth day, and will be recorded. Two questionnaires will be giving to the mothers on the third day. Maternal satisfaction  from postpartum care and their experiences of kangaroo care will be measured on the third day after birth</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of bilirubin. Timepoint: Immediately after birth, 24 hours after birth, 36 hours after birth, 5 days after birth. Method of measurement: With using from Billy Check (K-J-8000 model, made in Chin).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mothers satisfaction from care after birth. Timepoint: Mothers discharge day from hospital. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>The mothers experience of kangaroo mother care. Timepoint: Mothers discharge day from hospital. Method of measurement: Questionnaire.</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>Deputy of research, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-06</approval_date>
        <contact_name>Deputy of research,Tabriz University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research, Tabriz University of Medical Sciences, Golgasht Street, Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
