<?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>IRCT20221120056556N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-24</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of (NSIMV)  Nasal Synchronized Intermittent Mandatory Ventilation  whit (NHFOV) Nasal high frequency oscillatory ventilation in neonates requiring non-invasive mechanical ventilation in Mofid Pediatric Hospital</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of (NSIMV)  Nasal Synchronized Intermittent Mandatory Ventilation  whit (NHFOV) Nasal high frequency oscillatory ventilation in neonates requiring non-invasive mechanical ventilation in Mofid Pediatric Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68095</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Premature babies needing non-invasive mechanical ventilation are divided into two non-invasive mechanical ventilation groups(HFO and SIMV) using simple randomization method and random number table. So that patients who met the criteria s to enter the study will be assigned a number, and then without prior knowledge, even numbers will be placed in the intervention group and odd numbers will be placed in the control group. In this way, each member of the community will have an equal chance to be selected in order to be included in both intervention and control groups, and the researcher will not interfere in the selection of samples, Blinding description: In this study, premature babies who need non-invasive mechanical ventilation will be divided into two groups. Due to the study method and the impossibility of blinding mechanical ventilation, the doctor and nurse caring for the baby will be informed about the selected method for non-invasive mechanical ventilation, but the statistical analyzer of the research will not be informed about the allocation of patients in two groups.</study_design>
      <phase>2</phase>
      <hc_freetext>Respiratory Distress Syndrome/ Prematurity.</hc_freetext>
      <i_freetext>Intervention group: Premature babies with a gestational age of more than 26 weeks need non-invasive mechanical ventilation.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is After starting the study and conducting the pilot, action will be taken to publish and make the study available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>minoo fallahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1546815514</zip>
        <telephone>+98 21 2292 2828</telephone>
        <email>minou_fallahi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minoo Fallahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1546815514</zip>
        <telephone>+98 21 2292 2828</telephone>
        <email>minou_fallahi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria include: Premature babies hospitalized in the intensive care unit with a gestational age of more than 26 weeks who need respiratory support.
Informed consents of the baby's parents</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>30 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Babies who were intubated for resuscitation or for another reason before randomization.
cardio-pulmonary arrest requiring prolonged resuscitation
lack of consent of the baby's parents
Transferring the baby out of the neonatal intensive care unit   before randomization
In infants with the contraindication of non-invasive mechanical ventilation, such as infants with esophageal atresia or diaphragmatic hernia within 10 to 14 days after surgery
Babies with head and face anomalies that do not allow ventilation inside the baby's nose, such as cleft lip and palate
Intraventricular hemorrhage in grade 3 and 4</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P22</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory distress of newborn</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Premature babies with a gestational age of more than 26 weeks need non-invasive mechanical ventilation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of need for mechanical ventilation in premature infants under study. Timepoint: In the total hospitalization time of the premature baby under study in the neonatal intensive care unit. Method of measurement: The number of days without the need for mechanical ventilation in the baby.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patent ductus arteriosus. Timepoint: During the hospitalization of the baby. Method of measurement: Echocardiography by pediatric cardiologist.</sec_outcome>
      <sec_outcome>Retinopathy of permaturity. Timepoint: During the hospitalization of the baby. Method of measurement: By Ophthalmologist retina subspecialties.</sec_outcome>
      <sec_outcome>Intraventricular hemorrhage. Timepoint: During the hospitalization of the baby. Method of measurement: Brain sonography by  pediatric radiologist.</sec_outcome>
      <sec_outcome>Necrotizing enterocollitis. Timepoint: During the hospitalization of the baby. Method of measurement: Clinical sings according to BELL score and abdominal sonography by pediatric radiologist.</sec_outcome>
      <sec_outcome>Bronchopulmonary dysplasia. Timepoint: During the hospitalization of the baby. Method of measurement: Clinical signs and radiologic findings.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-19</approval_date>
        <contact_name>Ethic Committee of Shahid Beheshti University of Medical Scences</contact_name>
        <contact_address>7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
