<?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>IRCT20120614010026N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-13</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the relationship between NCPAP use and chronic lung disease in preterm infants.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the relationship between isolation from NCPAP at 3 and 5 cm H2O pressures with the incidence of BPD in neonates admitted to the NICU ward with a gestational age less than or equal to 32 weeks and birth weight less than or equal to 1500 grams.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>206</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61821</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling is done by Randomized by assignment method using double-blind randomized blocks, as one of the groups called A and the other B is named. The order of group A or B is an AB or BA method, and a block is formed for both eligible infants that are admitted to the NICU section. Then, based on the mother's family name and random numbers in numbers, 0 4 arrangements AB and numbers 5 9 BA arranged to reach the sample size, Blinding description: In this study, parents of neonates (participants) are blind to their baby than the type of respiratory intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bronchopulmonary dysplasia.</hc_freetext>
      <i_freetext>Intervention 1: In infants in the intervention group who are under CPAP (Continuous Positive Airway Pressure) if the clinical condition is stable at 5CmH2O, the CPAP pressure is reduced by one every 12 hours to 3CmH2O and then the infant is removed from the device and if necessary , Receive oxygen supplementation with hood with flow of 10 Lit / min. If SPO2 is tolerated and maintained between 91-95% in room air for at least four hours, no oxygen supplementation is required. Intervention 2: Infants in the control group under CPAP (Continuous Positive Airway Pressure) are isolated from the device if they have stable clinical conditions at 5CmH2O pressure and, if necessary, receive supplemental oxygen by oxyhood method with a flow rate of 10 Lit / min. If SPO2 is tolerated and maintained between 95-91% in room air for at least 4 hours, no oxygen supplementation is required.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Amir Mohammad Armanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib St, Isfahan University of Medical Sciences, Department of Pediatrics</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 8597</telephone>
        <email>armanian@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Amir Mohammad Armanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib St, Isfahan University of Medical Sciences, Department of Pediatrics</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 8597</telephone>
        <email>armanian@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All preterm infants less than or equal to 32 weeks of gestation and weighing less than or equal to 1500 g receiving NCPAP for at least 24 hours immediately after birth with a diagnosis of RDS.</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>28 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Congenital heart disease,
Third and fourth degree intraventricular hemorrhage,
Need surgery
Major anomalies
Need to be sent to other medical centers
Receive NCPAP in less than 24 hours
Apgar score less than 4 in 5 minutes of birth
Asphyxia,
Having Craniofacial abnormalities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>In infants in the intervention group who are under CPAP (Continuous Positive Airway Pressure) if the clinical condition is stable at 5CmH2O, the CPAP pressure is reduced by one every 12 hours to 3CmH2O and then the infant is removed from the device and if necessary , Receive oxygen supplementation with hood with flow of 10 Lit / min. If SPO2 is tolerated and maintained between 91-95% in room air for at least four hours, no oxygen supplementation is required.</i_keyword>
      <i_keyword>Infants in the control group under CPAP (Continuous Positive Airway Pressure) are isolated from the device if they have stable clinical conditions at 5CmH2O pressure and, if necessary, receive supplemental oxygen by oxyhood method with a flow rate of 10 Lit / min. If SPO2 is tolerated and maintained between 95-91% in room air for at least 4 hours, no oxygen supplementation is required.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rate of Bronchopulmonary Dysplasia. Timepoint: 28th birthday. Method of measurement: daily recorded sheet.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Frequency distribution of pneumothorax. Timepoint: At the time of discharge from the hospital. Method of measurement: Using a questionnaire and daily recorded sheet.</sec_outcome>
      <sec_outcome>Frequency distribution of intraventricular hemorrhage(IVH). Timepoint: At the time of discharge from the hospital. Method of measurement: Using brain ultrasound.</sec_outcome>
      <sec_outcome>Frequency distribution of Patent ductus arteriosus (PDA). Timepoint: At the time of discharge from the hospital. Method of measurement: Using echocardiography.</sec_outcome>
      <sec_outcome>Duration of oxygen dependence. Timepoint: At the time of discharge from the hospital. Method of measurement: Using a questionnaire and daily recorded sheet.</sec_outcome>
      <sec_outcome>Time to reach full enteral nutrition. Timepoint: At the time of discharge from the hospital. Method of measurement: Using a questionnaire and daily recorded sheet.</sec_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: At the time of discharge from the hospital. Method of measurement: Using a questionnaire and daily recorded sheet.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-06</approval_date>
        <contact_name>Medical Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib St., Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
