<?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>IRCT2017062734782N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-09</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>The efficacy of nasal high frequency ventilation in treatment of neonatal respiratory syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Therapeutic effect of Nasal high frequency ventilation(NHFV) versus nasal continuous positive airway pressure(NCPAP)  for respiratory distress syndrome in newborn with birth with more than 1000 gram and more than 30 week of gestational age</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26488</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Respiratory distress syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Infants with respiratory distress syndrome according of inclusion criteria randomized to NCPAP (control group) will treat with nasal CPAP shortly after birth. CPAP pressure will consider as 6-7 cmH20 and FIO2 adjust to maintain o2 saturation of patients between 89-95%.  Surfactant (200mg/kg first dose and then 100mg/kg the next doses, curosurf (Chiesa pharmaceuticals, Parma, Italy) will administrate if patients need FIo2 &gt; 35% to keep desired SPO2. If FIO2 reach to under 30% patient wean to Humidified High Flow Nasal Cannula (HHFNC) and when FIO2 reach to 21% and respiratory distress improved, HHFNC also will discontinued. &#13;
Surfactant administrate as INSURE method. NCPAP failure defined as apnea or PH&lt;7.2 and Pco2 &gt;60 mmHg. Intervention 2: Infants with respiratory distress syndrome according of inclusion criteria randomized to NHFV (control group) will treat with nasal high frequency ventilator [Fabian, Acutronic Medical Systems AG, based in Hirzel (Zurich, Switzerland)], shortly after birth. Pmean pressure will consider as 8 cmH20 and FIO2 adjust to maintain O2 saturation of patients between 89-95%. Initial frequency will set as 10 Hz. Amplitude will set based the vibration of upper chest wall and the neck of patients and increased to maximum 20mmHg.   Surfactant (200mg/kg first dose and then 100mg/kg the next doses, curosurf (Chiesa pharmaceuticals, Parma, Italy) will administrate if patients need FIo2 &gt; 35% to keep desired SPO2. If FIO2 reach to under 30% patient wean to Humidified High Flow Nasal Cannula (HHFNC) and when FIO2 reach to 21% and respiratory distress improved, HHFNC also will discontinued. Surfactant administrate as INSURE method. NCPAP failure defined as apnea or PH&lt;7.2 and Pco2 &gt;60 mmHg.</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>Dr Ahmadreza Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan medical faculty, Pediatric ward</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3386 8247</telephone>
        <email>Aabedi58@yahoo.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ramin Iranpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mardavij avenue, Resalat Jonobi, Number16</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8168967893</zip>
        <telephone>+98 31 3668 1555</telephone>
        <email>iranpour@med.mui.ac.irramin.iranpour@gmail.com</email>
        <affiliation>Isfahan 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: premature and term neonate; more than 1000 gram and 30 weeks of gestational age; spontaneous breathing; respiratory distress syndrome symptoms required treatment&#13;
Exclusion criteria: major congenital anomaly; diaphragmatic hernia; cyanotic heart disease; intrauterine growth retardation; asphyxia</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>1 month</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P22.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory distress syndrome of newborn</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Infants with respiratory distress syndrome according of inclusion criteria randomized to NCPAP (control group) will treat with nasal CPAP shortly after birth. CPAP pressure will consider as 6-7 cmH20 and FIO2 adjust to maintain o2 saturation of patients between 89-95%.  Surfactant (200mg/kg first dose and then 100mg/kg the next doses, curosurf (Chiesa pharmaceuticals, Parma, Italy) will administrate if patients need FIo2 &gt; 35% to keep desired SPO2. If FIO2 reach to under 30% patient wean to Humidified High Flow Nasal Cannula (HHFNC) and when FIO2 reach to 21% and respiratory distress improved, HHFNC also will discontinued. &#13;
Surfactant administrate as INSURE method. NCPAP failure defined as apnea or PH&lt;7.2 and Pco2 &gt;60 mmHg.</i_keyword>
      <i_keyword>Infants with respiratory distress syndrome according of inclusion criteria randomized to NHFV (control group) will treat with nasal high frequency ventilator [Fabian, Acutronic Medical Systems AG, based in Hirzel (Zurich, Switzerland)], shortly after birth. Pmean pressure will consider as 8 cmH20 and FIO2 adjust to maintain O2 saturation of patients between 89-95%. Initial frequency will set as 10 Hz. Amplitude will set based the vibration of upper chest wall and the neck of patients and increased to maximum 20mmHg.   Surfactant (200mg/kg first dose and then 100mg/kg the next doses, curosurf (Chiesa pharmaceuticals, Parma, Italy) will administrate if patients need FIo2 &gt; 35% to keep desired SPO2. If FIO2 reach to under 30% patient wean to Humidified High Flow Nasal Cannula (HHFNC) and when FIO2 reach to 21% and respiratory distress improved, HHFNC also will discontinued. Surfactant administrate as INSURE method. NCPAP failure defined as apnea or PH&lt;7.2 and Pco2 &gt;60 mmHg.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The duration of non-invasive support. Timepoint: Every hour. Method of measurement: hourly NICU recorded sheets.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pulmonary hemorrhage. Timepoint: hourly. Method of measurement: physical exam and chest xray if needed.</sec_outcome>
      <sec_outcome>Narcotizing enterocolitis (NEC). Timepoint: Daily. Method of measurement: Daily recorded sheets and daily physical exam and abdominal xray if needed.</sec_outcome>
      <sec_outcome>Intraventricular hemorrhage (IVH). Timepoint: at the 3rd and 7th days after birth. Method of measurement: brain sonography.</sec_outcome>
      <sec_outcome>Respiratory failure and intubation. Timepoint: continuously every hour during non-invasive respiratory support. Method of measurement: NICU record sheets.</sec_outcome>
      <sec_outcome>Pnuemothorax. Timepoint: continuously every hour during non-invasive respiratory support. Method of measurement: NICU record sheets.</sec_outcome>
      <sec_outcome>Chronic lung disease. Timepoint: 4 weeks after birth. Method of measurement: NICU record sheets.</sec_outcome>
      <sec_outcome>Patent ductus arteriosus. Timepoint: Daily physical exam. Method of measurement: Daily recorded sheets.</sec_outcome>
      <sec_outcome>Time to full enteral feeding. Timepoint: Daily till full feeding. Method of measurement: Daily recorded sheets.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-21</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar-Jerib St.,Isfahan University of Medical Sciences Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
