<?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>IRCT2015121925601N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-04</date_registration>
      <primary_sponsor>Vice chancellor for research, Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigate the aromatherapy with damask rose extracts to reduce apnea in premature infants hospitalized in NICU ward of selected training hospitals of  Esfahan in 2015</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness and ineffectiveness of aromatherapy with damask rose extracts to reduce apnea in premature infants hospitalized in NICU ward of selected training hospitals of  Esfahan in 2015</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21378</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomly by tossing coin.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Apnea.</hc_freetext>
      <i_freetext>Intervention 1: In the experimental group, in addition to conventional therapy,aromatherapy with damask rose extracts  starton the second day of birth  from 6Am and by pouring2 drops of damask rose extracts 10% on linen that is located at a distance of 3 cm  of infant head then  at, 9,12, 15, 18, o’clock  will repeat. In each time the heart rate and arterial oxygen recorded by the monitoring device and episodes of apnea with direct observation  will bechart and record . Intervention 2: In the control group in addition to conventional therapy, therapy on the second day of birth  from 6Am and by pouring2 drops of Distilled water on linen that is located at a distance of 3 cm  of infant head then  at, 9.12, 15, 18, o’clock  will repeat. In each time the heart rate and arterial oxygen recorded by the monitoring device and episodes of apnea with direct observation  will be chart and record .</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>Saeideh Agha Goli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrate Masomeh Hospital, Before terminal, After Shahid Zeinodin Square</address>
        <city>Ghom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21636665553</telephone>
        <email>Aghagoli1974@gmail.com</email>
        <affiliation>Hazrate Masomeh Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohreh Ghazavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Esfahan University of Medical Sciences, Hezarjarib Street</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 3060</telephone>
        <email>ZOHRE_GHAZAVI@NM.MUI.AC.IR</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: infants between 29-33 weeks gestational age; birth weight between 900-1500 grams; The baby's blood hemoglobin level higher than 10g /dl;infants Parental consent; Lack of oxygen uptake through cpAP; no need for infant ventilator; lack of heart disease or any infection.&#13;
Exclusion criteria were: discharge or death of an infant before the end of the intervention period; the incidence of respiratory symptoms and skin allergy during the study.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J98</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of the respiratory system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the experimental group, in addition to conventional therapy,aromatherapy with damask rose extracts  starton the second day of birth  from 6Am and by pouring2 drops of damask rose extracts 10% on linen that is located at a distance of 3 cm  of infant head then  at, 9,12, 15, 18, o’clock  will repeat. In each time the heart rate and arterial oxygen recorded by the monitoring device and episodes of apnea with direct observation  will bechart and record .</i_keyword>
      <i_keyword>In the control group in addition to conventional therapy, therapy on the second day of birth  from 6Am and by pouring2 drops of Distilled water on linen that is located at a distance of 3 cm  of infant head then  at, 9.12, 15, 18, o’clock  will repeat. In each time the heart rate and arterial oxygen recorded by the monitoring device and episodes of apnea with direct observation  will be chart and record .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate. Timepoint: 24 hours after birth, and 9, 12, 15, 18 hours after the first 24 hours. Method of measurement: By monitoring device.</prim_outcome>
      <prim_outcome>Arterial blood oxygen saturation percent. Timepoint: 24 hours after birth, and 9, 12, 15, 18 hours after the first 24 hours. Method of measurement: By monitoring device.</prim_outcome>
      <prim_outcome>The number of episodes of apnea. Timepoint: 24 hours after birth, and 9, 12, 15, 18 hours after the first 24 hours. Method of measurement: By direct observation.</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>Vice chancellor for research, Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-31</approval_date>
        <contact_name>Committee Ethics, Esfahan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, Hezarjarib Street Esfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
