<?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>IRCT201101234613N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-03-29</date_registration>
      <primary_sponsor>Research Deputy, Tabriz University of  Medical Sciences</primary_sponsor>
      <public_title>Effect of massage on physiological Parameters of Premature infants</public_title>
      <acronym></acronym>
      <scientific_title>Effect of massage on physiological Parameters of Premature infants under Nasal continuous positive airway pressure through nasal (NCPAP) in Al-Zahra Hospital, Tabriz, 2010.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-02-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4927</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premature Newborn NCPAP hospitalized in NICU.</hc_freetext>
      <i_freetext>Intervention 1: In premature infants treated with NCPAP initially Respiratory Rate (RR), heart rate (HR), Fraction of Inspired oxygen (FIO2) and arterial oxygen saturation (SatO2), blood pressure (BP) and body temperature (from axillary) (T) in position Peron determined and is recorded in the checklist. The infants were randomly assigned to three groups:&#13;
Intervention groups 1(massage with sunflower oil) 10 ml oil per kg birth weight is used. Massage therapy is done by the researcher (NICU student) with modify Weiss method in accordance with the conditions of newborns and neonatologist order. Then the baby's massage with coconut and sunflower oils during the day and once every 15 minutes on three consecutive days is given. Infant massage started of the neck and ends his legs. Neck, back and hands and legs infant massage is given and the head, chest and abdominal massage does not hold the baby. Research fellow in five minutes before the procedure and three times during the massage (5 minutes, 10 and 15) and then after 5 minutes of massage, respiration, heart rate, blood pressure and temperature, and oxygen saturation concentration inhaled oxygen and neonatal complications resulting from the above NCPAP. Intervention 2: Intervention group 2 (massage with coconut oil) 10 ml oil per kg birth weight is used. Massage therapy is done by the researcher (NICU student) with modify Weiss method in accordance with the conditions of newborns and neonatologist order. Then the baby's massage with coconut and sunflower oils during the day and once every 15 minutes on three consecutive days is given. Infant massage started of the neck and ends his legs. Neck, back and hands and legs infant massage is given and the head, chest and abdominal massage does not hold the baby. Research fellow in five minutes before the procedure and three times during the massage (5 minutes, 10 and 15) and then after 5 minutes of massage, respiration rate, heart rate, blood pressure and temperature, and oxygen saturation concentration and neonatal complications resulting from the above NCPAP. Intervention 3: Control group (routine care without massage) also were measured respiration rate, heart rate, blood pressure and temperature, and oxygen saturation concentration in the same time.</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>Najmeh Ajoodaniyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing And Midwifery Faculty</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1479 0365</telephone>
        <email>ajoodaniyan@yahoo.com ajoodaniyan.n@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: gestational age 28-32 weeks and weight 1000 to 2000 grams, treated with continuous positive airway pressure, not treated by respirator, infants under NCPAP after 12 hours of birth, Axillary temperature is between 36/5-37° C, not having abnormalities or congenital neurological problems, cardiac-vascular and inherited diseases, Arterial blood oxygen saturation at least 92 percent, not having contraindication for touch. &#13;
Exclusion criteria: mother’s addiction to alcohol, cigarettes or drugs or other medications, any indication for surgery, gastric disorders, intestinal or central nervous system disorders, having a chest tube, infants who require FIO2 more than 70 percent, having serious systemic infection, tachycardia (more than 180 beats per minute), bradycardia (less than 90 beats per minute), resistant (more than two time)</inclusion_criteria>
      <agemin>28 years</agemin>
      <agemax>32 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P22.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory distress syndrome of newborn</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In premature infants treated with NCPAP initially Respiratory Rate (RR), heart rate (HR), Fraction of Inspired oxygen (FIO2) and arterial oxygen saturation (SatO2), blood pressure (BP) and body temperature (from axillary) (T) in position Peron determined and is recorded in the checklist. The infants were randomly assigned to three groups:&#13;
Intervention groups 1(massage with sunflower oil) 10 ml oil per kg birth weight is used. Massage therapy is done by the researcher (NICU student) with modify Weiss method in accordance with the conditions of newborns and neonatologist order. Then the baby's massage with coconut and sunflower oils during the day and once every 15 minutes on three consecutive days is given. Infant massage started of the neck and ends his legs. Neck, back and hands and legs infant massage is given and the head, chest and abdominal massage does not hold the baby. Research fellow in five minutes before the procedure and three times during the massage (5 minutes, 10 and 15) and then after 5 minutes of massage, respiration, heart rate, blood pressure and temperature, and oxygen saturation concentration inhaled oxygen and neonatal complications resulting from the above NCPAP.</i_keyword>
      <i_keyword>Intervention group 2 (massage with coconut oil) 10 ml oil per kg birth weight is used. Massage therapy is done by the researcher (NICU student) with modify Weiss method in accordance with the conditions of newborns and neonatologist order. Then the baby's massage with coconut and sunflower oils during the day and once every 15 minutes on three consecutive days is given. Infant massage started of the neck and ends his legs. Neck, back and hands and legs infant massage is given and the head, chest and abdominal massage does not hold the baby. Research fellow in five minutes before the procedure and three times during the massage (5 minutes, 10 and 15) and then after 5 minutes of massage, respiration rate, heart rate, blood pressure and temperature, and oxygen saturation concentration and neonatal complications resulting from the above NCPAP.</i_keyword>
      <i_keyword>Control group (routine care without massage) also were measured respiration rate, heart rate, blood pressure and temperature, and oxygen saturation concentration in the same time.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physiological Parameters of Premature infants under NCPAP. Timepoint: 5 minutes before massage, 5, 10, 15 minutes massage and 5 minutes after massage. Method of measurement: monitor device model S1600 poyandegan rahe saadat, wellshaleene digital and manufactured Medin Easy Blender.</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>Research Deputy, Tabriz University of  Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-01-17</approval_date>
        <contact_name>Deputy of Research, Tabriz University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research, Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
