<?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>IRCT2017071135012N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-28</date_registration>
      <primary_sponsor>Vice Chancellor for research of Iran University of Medical sciences</primary_sponsor>
      <public_title>Effect of massage  on behavioral state and weigh gain</public_title>
      <acronym>M technique</acronym>
      <scientific_title>The effect of M technique on physiologic parameters, behavioral state, and weight gain in preterm neonates admitted to neonatal intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26592</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Neonatal Prematurity.</hc_freetext>
      <i_freetext>Intervention 1: The M technique is a structured massage method that aims at reducing stress in a neonatal, neonatal, neonatal, neonatal intensive care unit that can not tolerate traditional massage techniques. The protocols for this method, which have been extracted from the two previous studies, and the teaching or doing video produced by Mrs. Jane Buckle, are available to all members of the research team.&#13;
The infants in the test group receive the following intervention: the infant is resting on the lower abdomen and the upper half of the helping agent is opened. The lower ends and the hips are well supported in the accumulated condition. One hand is taken in a cup. And with the other hand, the head and the other extremities of the baby are protected. Pressures start at pressure 3 (0 to 10), which is rhythmic and stepwise. Each pressure is repeated 3 times. Pressures are lost with the second and third finger pads both. The duration of this technique is 5 minutes (approximately 20 seconds per pressure). This technique is achieved by touching and supporting and slowly finishing Finds. Intervention 2: All newborns in the conventional evolutionary care group in the neonatal intensive care unit, such as skin contact, parental presence, neurodevelopmental assessments provided by the physician and clinical occupational therapist, use of conditional support and care for the sleep cycle, andake up will be received.</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>Mona Alinejad Naeine</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr Ave., Rashid Yasemi Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>mona_alinejad@yahoo.com</email>
        <affiliation>School of nursing and midwiefry, Iran University of Medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mona Alinejad Naeine</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr Ave., Rashid Yasemi Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>mona_alinejad@ yahoo.com</email>
        <affiliation>faculty member of pediatric department of nursing and midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age 28-30 weeks; Birth weight 800 to 1400 grams; Exclusion criteria: Existing abnormalities; Heart failure; Chest tube; need To oxygen more than 75%); stable tachycardia; stable bradycardia;</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>10 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The M technique is a structured massage method that aims at reducing stress in a neonatal, neonatal, neonatal, neonatal intensive care unit that can not tolerate traditional massage techniques. The protocols for this method, which have been extracted from the two previous studies, and the teaching or doing video produced by Mrs. Jane Buckle, are available to all members of the research team.&#13;
The infants in the test group receive the following intervention: the infant is resting on the lower abdomen and the upper half of the helping agent is opened. The lower ends and the hips are well supported in the accumulated condition. One hand is taken in a cup. And with the other hand, the head and the other extremities of the baby are protected. Pressures start at pressure 3 (0 to 10), which is rhythmic and stepwise. Each pressure is repeated 3 times. Pressures are lost with the second and third finger pads both. The duration of this technique is 5 minutes (approximately 20 seconds per pressure). This technique is achieved by touching and supporting and slowly finishing Finds.</i_keyword>
      <i_keyword>All newborns in the conventional evolutionary care group in the neonatal intensive care unit, such as skin contact, parental presence, neurodevelopmental assessments provided by the physician and clinical occupational therapist, use of conditional support and care for the sleep cycle, andake up will be received.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physiological parameters. Timepoint: 5 minutes before intervention as baseline data and then every minute for 7 minutes and then 10 minutes after intervention. Method of measurement: the use of neonatal pals oximetry.</prim_outcome>
      <prim_outcome>Neonatal weight gain. Timepoint: Once before the intervention, then on a daily basis. Method of measurement: Baby scales.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Behavioral state. Timepoint: The duration of the intervention is based on the protocol of 7 minutes, each period of the intervention is from 8 am to 11 pm, based on the clinical situation and the readiness of the infant. Measure the behavioral status of 5 stings before the intervention and then every minute for 7 minutes and 10 minutes after the intervention is measured. Method of measurement: Anderson Behavioral State Scale (ABSS).</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 Iran University of Medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-14</approval_date>
        <contact_name>Ethics committee of Iran University of Medical sciences</contact_name>
        <contact_address>Shahid Hemmat Highway Teharn  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
