<?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>IRCT201509211788N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-30</date_registration>
      <primary_sponsor>International Campus University of Medical Sciences- Research Center School of Nursing and Midwifer</primary_sponsor>
      <public_title>The effects of prone and supine positioning on abdominal distention.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between supine and prone positions on the abdominal distention in premature infants supported with nasal positive airway pressure.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1371</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Abdominal Distention.</hc_freetext>
      <i_freetext>This cross over study was done on 35 infants who are treated with nasal ventilation positive pressure. After selecting the samples, the informed consent will obtained from the parents of the babies. Thus, half of the babies in the study first and then lying prone, supine and the other half of the babies in the supine position and then the abdomen will be a lying position and results of the study will be compared together. Researcher in order to determine abdominal distention in preterm infants with respiratory distress syndrome under continuous positive airway pressure ventilation will record the pressure on the airways and also amount of received milk in a day. After ensuring of receiving the milk by oral or gavage and after 15 minutes the measurement of abdominal circumference will start. Also before giving positions to register waist with meter paper that the 1 cm above the navel will be measured, waist to stabilize the situation and the loss due to positions prior to 60 minutes before any positions, with meter Paper will be measured by the researcher. It measures 30, 60, 90, 120 minutes after the position ultimately taken scores of abdominal distention in these two positions, will be compared with each other..</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>Leili Borimnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Vali-Asr, Vanak Square, Street Rasheed Yassami</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>Borimnejad.l@iums.ac.ir- fnm@iums.ac.ir</email>
        <affiliation>School of Nursing and Midwifery, Iran University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa Mohagheghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Rashid yasemi st, Valiasr st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14665-354</zip>
        <telephone>+98 21 86709</telephone>
        <email>drmohagh@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Infants 32-36 weeks gestational age at birth, birth weight in the range of 1000-2000 g, first and fifth minute Apgar score above 7, the infants who with respiratory distress syndrome that require respiratory assistance, also were not known with revealed congenital disorder and known infection. Infants should be under continuous positive airway pressure ventilation or noninvasive ventilation (Duopap) through the nose with a nasal by prong or mask, under nutrition with breastfeeding or oral gavage.&#13;
Exclusion criteria: The infants who with congenital malformations like gastroschisis, omphalocele, myelomeningocele, heart abnormalities. if needs to have surgery or mechanical ventilation through an endotracheal tube, detach of continuous positive airway pressure device, re-feeding of infants in less than 120 minutes at the desired positions will be excluded.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Symptoms and signs involving the digestive system and abdomen Abdominal Distention</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This cross over study was done on 35 infants who are treated with nasal ventilation positive pressure. After selecting the samples, the informed consent will obtained from the parents of the babies. Thus, half of the babies in the study first and then lying prone, supine and the other half of the babies in the supine position and then the abdomen will be a lying position and results of the study will be compared together. Researcher in order to determine abdominal distention in preterm infants with respiratory distress syndrome under continuous positive airway pressure ventilation will record the pressure on the airways and also amount of received milk in a day. After ensuring of receiving the milk by oral or gavage and after 15 minutes the measurement of abdominal circumference will start. Also before giving positions to register waist with meter paper that the 1 cm above the navel will be measured, waist to stabilize the situation and the loss due to positions prior to 60 minutes before any positions, with meter Paper will be measured by the researcher. It measures 30, 60, 90, 120 minutes after the position ultimately taken scores of abdominal distention in these two positions, will be compared with each other.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abdominal distention. Timepoint: After ensuring of receiving the milk by oral or gavage and after 15 minutes the measurement of abdominal circumference will start. Also before giving positions to register waist with meter paper that the 1 cm above the navel will be measured, waist to stabilize the situation and the loss due to positions prior to 60 minutes before any positions, with meter Paper will be measured by the researcher. It measures 30, 60, 90, 120 minutes after the position ultimately taken scores of abdominal distention in these two positions, will be compared with each other. Method of measurement: The waist recording will use by the meter paper that be measured 1 cm above the navel.</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>International Campus University of Medical Sciences- Research Center School of Nursing and Midwifer</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-22</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>Office Of Vice Chancellor For International Affairs, Iran University Of Medical Sciences, Hemmat Highway, Tehran, Iran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
