<?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>IRCT201206059949N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-06-22</date_registration>
      <primary_sponsor>Research deputy of Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effects of massage on bilirubin levels in preterm infants</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of bilirubin levels on preterm infants 30-36 weeks gestational age  in massage and routine care groups</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-10-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10466</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Neonatal jaundice, unspecified.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group : In the intervention group, the researcher will be massaged the infants twice a day on five consecutive days. Before the intervention, transcutaneous bilirubin levels are determined using a bilirubin analyzer. The researcher washes her hands thoroughly and warms and oils them, and will be massaged the infants with the soft parts of the fingers of both hands applying gentle pressure and using Field’s technique. The neonates massage will carry out in 15-minute sessions. 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 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. Intervention 2: The control group: Infants in the control group will receive routine care and no intervention will be performed on them.</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>Soheila Karbandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Nursing and Midwifery Faculty, Ebn-e Sina Avenue, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>karbandis@mums.ac.ir; nms.it@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hasan Boskabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaem Hospital, Ahmad Abad Boulevard, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9176699199</zip>
        <telephone>+98 51 3801 2592</telephone>
        <email>BoskabadiH@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: stabilization of neonate's condition (12-24 hours after birth), Apgar score 7 or more, gestational age 30-36 weeks, weighing more than 1250 g, 5th minutes after birth Apgar score 7 or more, lack of any massage contraindication (like wound, skin lesions, burn, ecchymosis, fracture or joint dislocation, infectious rush and hyperthermia), lack of obvious congenital anomalies, absence of congenital infection  &#13;
Exclusion criteria: getting neonatal clinical Icter after 24 hours after birth, any proof of known causes of jaundice like: Glucose-6-phosphate dehydrogenase deficiency, hypothyroidism, RH or ABO incompatibility or any evidence of erythrocytes lysis, getting phototherapy, blood transfusion and medication (drugs such as intravenous Immunoglobulin, Metalloporphyrins and Clofibrate) for jaundice a day after birth, Infection during the study (blood culture or cerebrospinal fluid culture - positive CSF).</inclusion_criteria>
      <agemin>7 months</agemin>
      <agemax>8 months</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>Physiological jaundice (intense)(prolonged) NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group : In the intervention group, the researcher will be massaged the infants twice a day on five consecutive days. Before the intervention, transcutaneous bilirubin levels are determined using a bilirubin analyzer. The researcher washes her hands thoroughly and warms and oils them, and will be massaged the infants with the soft parts of the fingers of both hands applying gentle pressure and using Field’s technique. The neonates massage will carry out in 15-minute sessions. 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 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.</i_keyword>
      <i_keyword>The control group: Infants in the control group will receive routine care and no intervention will be performed on them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Skin bilirubin levels. Timepoint: Before the intervention, and then daily until the tenth day or discharged date. Method of measurement: in mg/dl with transcutaneous bilirubinometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stool frequency. Timepoint: daily until the tenth day or discharged date. Method of measurement: Depending on the number recorded in the infants’ files.</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>Research deputy of Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-10-20</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>After Doktora Cross, Daneshgah Avenue, Taghi Abad Square Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
