<?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>IRCT138811043150N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-05-09</date_registration>
      <primary_sponsor>Vice chancellor for research, Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Massage on Serum Bilirubin Levels in Term Neonates</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Massage on Serum Bilirubin Levels in Term Neonates ffected with Hyperbilirubinemia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3200</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>Hyperbilirubinemia.</hc_freetext>
      <i_freetext>Intervention 1: intervention groups: tactile and kinesthetic stimulation will carry out by the mother under the supervision of the researcher in 15-minute sessions in 3 consecutive hours, daily for 4 days. Each session consisted of 3 standardized phases of 5 minutes each, in which the infants were keep in a prone position in the 1st and 3rd phase. The neonates will gently stroke with the soft, smooth surfaces of all the fingers of both hands. The tactile stimulation procedure included 12 strokes at a rate of approximately 5 seconds per stroking motion over each region of the neonate in the following sequence: • From the top of the head down the sides of the face to the neck, and vice versa • From the back of the neck to both ends of the shoulders, and vice versa • From the thighs down to the ankles, and vice versa • From the shoulders down the arms to the wrist, and vice versa In the middle phase, the neonate will make to lie in a supine position for kinesthetic stimulation that included 5 segments of 1 minute each which consist of 6 passive flexion/extension movements, each lasting 10sec. The stimulation will do on each arm, then each leg and lastly both legs together. The neonate will then return to a prone position to repeat the tactile stimulation phase. Massage intervention will carry out alongside phototherapy (without interruption) in the sample group at a fix hour between 7am and 7pm every day. Initially, phototherapy lamps will check  and adjust at a height of 30cm above the neonates who weill keep in the cots with eyes close and reproductory organs will protect. After every 2 hours of therapy a rest period of 30min. will give in which the neonates will allow to breast feed with eyes open. Bilirubin will measure at 6a.m. everydaycontrol group: without intervention. Intervention 2: control group will administer routine ward care.</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>Mahdi Basiri Moqadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to the Asian Road, Deputy for Research, Gonabad University of Medical Sciences and Health Services, Gonabad, Iran</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 53 3733 2629</telephone>
        <email>Basiri1344@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdi Basiri Moqadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to the Asian Road, Vice chancellor for research, Gonabad University of Medical Sciences and Health Services</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 53 3733 2629</telephone>
        <email>basiri1344@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  term neonates born after 37-42 weeks of pregnancy; weighing between 2500gm and 4000gm; having a bilirubin level of 13–24mg/dl; All the children were breast fed; were not under any medication and showed no contra-indications to massage.  Exclusion criteria: having jaundice on the 1st day of birth; hyper bilirubinemia caused by hemolysis; diseases or infections occurring in the course of the study; blood transfusion carried out in the infant; the occurrence of bronze children's syndrome during phototherapy; diarrhea during phototherapy; and lastly the desire of the parents to be omitted from the study.</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>7 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>p59.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal jaundice, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention groups: tactile and kinesthetic stimulation will carry out by the mother under the supervision of the researcher in 15-minute sessions in 3 consecutive hours, daily for 4 days. Each session consisted of 3 standardized phases of 5 minutes each, in which the infants were keep in a prone position in the 1st and 3rd phase. The neonates will gently stroke with the soft, smooth surfaces of all the fingers of both hands. The tactile stimulation procedure included 12 strokes at a rate of approximately 5 seconds per stroking motion over each region of the neonate in the following sequence: • From the top of the head down the sides of the face to the neck, and vice versa • From the back of the neck to both ends of the shoulders, and vice versa • From the thighs down to the ankles, and vice versa • From the shoulders down the arms to the wrist, and vice versa In the middle phase, the neonate will make to lie in a supine position for kinesthetic stimulation that included 5 segments of 1 minute each which consist of 6 passive flexion/extension movements, each lasting 10sec. The stimulation will do on each arm, then each leg and lastly both legs together. The neonate will then return to a prone position to repeat the tactile stimulation phase. Massage intervention will carry out alongside phototherapy (without interruption) in the sample group at a fix hour between 7am and 7pm every day. Initially, phototherapy lamps will check  and adjust at a height of 30cm above the neonates who weill keep in the cots with eyes close and reproductory organs will protect. After every 2 hours of therapy a rest period of 30min. will give in which the neonates will allow to breast feed with eyes open. Bilirubin will measure at 6a.m. everydaycontrol group: without intervention.</i_keyword>
      <i_keyword>control group will administer routine ward care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of Serum Bilirubin. Timepoint: Daily. Method of measurement: Blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Jaundice. Timepoint: End study. Method of measurement: Clinical Sign.</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, Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-04-21</approval_date>
        <contact_name>Ethics Committee of Gonabad univercity of medical sciences</contact_name>
        <contact_address>Vice chancellor for research, Gonabad university of medical sciences, Next to the Asian Road Gonabad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
