<?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>IRCT2014051217669N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-23</date_registration>
      <primary_sponsor>Vice chancellor for research, Babol University of Medical Sciences.</primary_sponsor>
      <public_title>The effect of ambient lighting  in preterm infant</public_title>
      <acronym></acronym>
      <scientific_title>Effect of  ambient lighting  on heart rate and blood oxygen saturation in preterm infant admitted to neonatal intensive care unit in Babol, Iran</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16189</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Effect of ambient lighting on heart rate and blood oxygen saturation in preterm infant.</hc_freetext>
      <i_freetext>In this study, gestational age was calculated by Ballard scale and intensity of brightness in the NICU through a device called a luxury meter with 3% ± confidence level in Taiwan, heart rate and oxygen saturation percentage in preterm infants by Saadat monitor, made in Iran was measured. In order to record data on the monitor, we use the probe including a light detector, put against each other and also the tissue layers (fingers of hand or foot) and also between them. In order to get demographic information, we use birth records after attracting personnel and explaining to the parents and getting consent from them. According to selected Infants at the same time from 12:00 to 13:00 on a routine part, amount of brightness have been estimated and recorded by luxury meter and then we record heart rate and arterial oxygen saturation percentage displayed on the monitor every 5 minutes. On the same day, on the same infant from 14:30 to 15:30, amount of brightness through controlling light by covering the incubator and putting the cover on the window with the blinds and turning off non-essential lights reached 10 luxuries and then we record their effect on heart rate and arterial oxygen saturation percentage every 5 minutes during the intervention..</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>Mr.Doctor Hadi Sorkhi.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir Kola Children Hospital، Babol، Mazandran، Iran.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11132549514</telephone>
        <email>pediatrics-amirkola@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mr.Doctor Mousa Ahmadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences،  Ganjafrooz Street،  Babol،  Mazandran، Iran.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 1324 2155</telephone>
        <email>mousa-ahmadpour@hotmail.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: premature infants less than 37 weeks; weighing less than 2500 grams; without the need for mechanical ventilation and oxygen therapy; arterial oxygen saturation in normal range.&#13;
Exclusion criteria: existence of neurological- vision problems; congenital anomalies; sepsis; gastro - intestinal tract problems; congenital heart disease; respiratory distress syndrome with more or equal to 5; maternal drug addiction; drugs affecting on heart rate and arterial oxygen saturation percentage; infants undergoing phototherapy in the hospital and suffering invasive procedures.</inclusion_criteria>
      <agemin>5 days</agemin>
      <agemax>28 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>Other preterm infants</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, gestational age was calculated by Ballard scale and intensity of brightness in the NICU through a device called a luxury meter with 3% ± confidence level in Taiwan, heart rate and oxygen saturation percentage in preterm infants by Saadat monitor, made in Iran was measured. In order to record data on the monitor, we use the probe including a light detector, put against each other and also the tissue layers (fingers of hand or foot) and also between them. In order to get demographic information, we use birth records after attracting personnel and explaining to the parents and getting consent from them. According to selected Infants at the same time from 12:00 to 13:00 on a routine part, amount of brightness have been estimated and recorded by luxury meter and then we record heart rate and arterial oxygen saturation percentage displayed on the monitor every 5 minutes. On the same day, on the same infant from 14:30 to 15:30, amount of brightness through controlling light by covering the incubator and putting the cover on the window with the blinds and turning off non-essential lights reached 10 luxuries and then we record their effect on heart rate and arterial oxygen saturation percentage every 5 minutes during the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ambient lighting. Timepoint: Before and during intervention every 5 minutes to an hour. Method of measurement: In terms of luxury and using luxury meter device.</prim_outcome>
      <prim_outcome>Hear rate. Timepoint: Before and during intervention every 5 minutes to an hour. Method of measurement: In terms of beats per minute using Monitor.</prim_outcome>
      <prim_outcome>Blood oxygen saturation. Timepoint: Before and during intervention every 5 minutes to an hour. Method of measurement: In terms of percentage using Monitor.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Gestational age. Timepoint: After  birth. Method of measurement: In terms of day and week using Ballard scale.</sec_outcome>
      <sec_outcome>Weight. Timepoint: After  birth. Method of measurement: In terms of gram using Balance.</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, Babol University of Medical Sciences.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-12-03</approval_date>
        <contact_name>Ethics committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Research and Technology،  Ganjafroz Street  Babol  university of Medical Science،  Babol، Mazandaran، Iran. Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
