<?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>IRCT2015081623636N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-09-16</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The effect of live maternal voice on physiologic factors of premature infants</public_title>
      <acronym></acronym>
      <scientific_title>The effect of live maternal voice on physiologic factors of premature infants hospitalized in NICU</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20144</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premature infant.</hc_freetext>
      <i_freetext>Intervention 1: First group: The infants of this group listen to their mothers’ live voice for 10 minutes.This group, 10 minutes before، 10 minutes during، 10 minutes after the intervention, the nurse records heart rate, blood oxygen saturation, blood pressure and respiratory rate every five minutes. Intervention 2: Second group: In this group, the mother stands beside the incubator for 10 minutes but does not speak to the infant. This group, 10 minutes before، 10 minutes during، 10 minutes after the intervention, the nurse records heart rate, blood oxygen saturation, blood pressure and respiratory rate every five minutes. Intervention 3: Third Group: The infants of this group listen to the nurse’s (researcher) live voice for 10 minutes.This group, 10 minutes before، 10 minutes during، 10 minutes after the intervention, the nurse records heart rate, blood oxygen saturation, blood pressure and respiratory rate every five minutes.</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>Mozhgan Ahmadi Vastani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 11 3310 5346</telephone>
        <email>Mozhganahmadivastani@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yadolla Zahed Pasha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 113219959296</telephone>
        <email>Zypasha@gmail.com</email>
        <affiliation>Babol 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:&#13;
 Premature infants with gestational age of 28 to less than 37 weeks; Birth weight of more than 1 kilograms and less than 2.5 kilograms; Infants that are at least 3 days old; Infants that are kept in incubator, have physiological stability and no congenital anomalies and their inclusion in the study is confirmed by the shift attending; Infants that are not under the effect of any kind of ventilation such as nasal cannula, positive pressure ventilation through nasal mask or ventilator; Receiving no muscle relaxant drug;  Not having surgery; Infants that are merely fed by their mother’s milk.&#13;
Exclusion Criteria:&#13;
 Startle reflex/ (ABR) hearing test indicate hearing impairment; Definitive diagnosis of the following issues during the intervention:Intraventricular hemorrhage with grade 2 and above; Necrotizing enterocolitis;  patent ductus arteriosus; sepsis; acute lung disease; anemia (Hb&lt;10gm / dr); occurrence of seizure and mother’s unwillingness to cooperate;  Infants that use pacifier or are fed by things other than mother’s milk; Reports that indicate mother’s known addiction to alcohol, addictive drugs (narcotic drugs) and psychotropic substances;The mother receive hypnotic drugs in the intervention day.</inclusion_criteria>
      <agemin>3 days</agemin>
      <agemax>29 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders related to short gestation and low birth weight, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First group: The infants of this group listen to their mothers’ live voice for 10 minutes.This group, 10 minutes before، 10 minutes during، 10 minutes after the intervention, the nurse records heart rate, blood oxygen saturation, blood pressure and respiratory rate every five minutes.</i_keyword>
      <i_keyword>Second group: In this group, the mother stands beside the incubator for 10 minutes but does not speak to the infant. This group, 10 minutes before، 10 minutes during، 10 minutes after the intervention, the nurse records heart rate, blood oxygen saturation, blood pressure and respiratory rate every five minutes.</i_keyword>
      <i_keyword>Third Group: The infants of this group listen to the nurse’s (researcher) live voice for 10 minutes.This group, 10 minutes before، 10 minutes during، 10 minutes after the intervention, the nurse records heart rate, blood oxygen saturation, blood pressure and respiratory rate every five minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate. Timepoint: 10 minut before-10 minute during-10 minute after intervention. Method of measurement: Monitor.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: 10 minut before-10 minute during-10 minute after intervention. Method of measurement: Monitor.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: 10 minut before-10 minute during-10 minute after intervention. Method of measurement: Monitor.</prim_outcome>
      <prim_outcome>Saturation of pressure of O2. Timepoint: 10 minut before-10 minute during-10 minute after intervention. Method of measurement: Monitor.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-02</approval_date>
        <contact_name>Babol University of Medical Sciences,</contact_name>
        <contact_address>Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran. Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
