<?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>IRCT201205213512N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-06-18</date_registration>
      <primary_sponsor>Mazandaran University of Medical Siences</primary_sponsor>
      <public_title>The effect of the use of  surfactant administration during NCPAP treatment  on complications of RDS</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of surfactant administration during NCPAP with NCPAP alone on mortality ,morbidity and complications of RDS in premature neonates</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3617</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 in the newborn.</hc_freetext>
      <i_freetext>Intervention 1: In control group nasal CPAP of 6 cm H2O  is administered for the patients and the infant remains on NCPAP.Any patient who needs mechanical ventilation (according to criteria below) is intubated and placed under intermittent mandatory ventilation (IMV) and is considered as nCPAP failure in control group. If needed Fio2 is more than 30% the resque dose of surfactant (Survanta ) is administered. Additional surfactant doses are given every 6 hours as long as Fio2 remains more than 30% but not after 48 hours of age. Intervention 2: In the treatment group the patient is placed on nCPAP and then temporarily intubated. A natural surfactant (Survanta , Abbot Laboratories, Abbot Park, IL) 100 mg/Kg is administered intratrachealy and the neonate is ventilated manually with Neopuff infant resuscitator (Fisher &amp; Paykel Healthcare, Inc, Auckland, New Zealand) with peak inspiratory pressure of 20 cm H2O and positive-end expiratory pressure of 5 cm H2O  only for some minutes and if the patient is stable extubation to NCPAP of 5 cm H2O is accomplished. Every patient on CPAP would receive Aminophylline with a loading dose of 5 mg/Kg and then 1 mg/Kg every 8 hour intravenously. &#13;
Any patient who needs mechanical ventilation  is intubated and placed under intermittent mandatory ventilation (IMV) and is considered as INSURE failure in treatment group . If needed Fio2 is more than 30% the resque dose of surfactant (Survanta ) is administered. Additional surfactant doses are given every 6 hours as long as Fio2 remains more than 30% but not after 48 hours of age.</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>Maryam Nakhshab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu-Ali Hospital, Sari, Mazandaran, Iran</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 15 1321 0853</telephone>
        <email>mnakhshab@mazums.ac.ir pegahch@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Siences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Nakhshab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>BuAli Hospital, Sari, Mazandran, Iran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 15 1321 0853</telephone>
        <email>mnakhshab@mazums.ac.ir   pegahch@yahoo.com</email>
        <affiliation>Mazandran University of Medical Siences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: gestational age less than 35 weeks; age less or equal to 12 hours after birth; the presence of symptoms of respiratory distress syndrom (RDS); symptoms begun in the first 6 hours after birth; radiologic signs for RDS in chest radiography. The exclusion criteria: 5 minutes Apgar score less than 6; intubation before reaching Bu-Ali Hospital, presence of major anomalies, PROM&gt; 12 hours, admission to Bu-Ali Hospital after 12 hours of age, signs and symptoms of chorioamnionitis in mother, beginning of respiratory distress after 6 hours of birth, need for mechanical ventilation (on the basis of our defined criteria) at the time the patient reaches to Bu-Ali Hospital.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>1 year</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</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In control group nasal CPAP of 6 cm H2O  is administered for the patients and the infant remains on NCPAP.Any patient who needs mechanical ventilation (according to criteria below) is intubated and placed under intermittent mandatory ventilation (IMV) and is considered as nCPAP failure in control group. If needed Fio2 is more than 30% the resque dose of surfactant (Survanta ) is administered. Additional surfactant doses are given every 6 hours as long as Fio2 remains more than 30% but not after 48 hours of age</i_keyword>
      <i_keyword>In the treatment group the patient is placed on nCPAP and then temporarily intubated. A natural surfactant (Survanta , Abbot Laboratories, Abbot Park, IL) 100 mg/Kg is administered intratrachealy and the neonate is ventilated manually with Neopuff infant resuscitator (Fisher &amp; Paykel Healthcare, Inc, Auckland, New Zealand) with peak inspiratory pressure of 20 cm H2O and positive-end expiratory pressure of 5 cm H2O  only for some minutes and if the patient is stable extubation to NCPAP of 5 cm H2O is accomplished. Every patient on CPAP would receive Aminophylline with a loading dose of 5 mg/Kg and then 1 mg/Kg every 8 hour intravenously. &#13;
Any patient who needs mechanical ventilation  is intubated and placed under intermittent mandatory ventilation (IMV) and is considered as INSURE failure in treatment group . If needed Fio2 is more than 30% the resque dose of surfactant (Survanta ) is administered. Additional surfactant doses are given every 6 hours as long as Fio2 remains more than 30% but not after 48 hours of age.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Need for mechanical ventilation. Timepoint: daily within the first week of life. Method of measurement: physical exam for significant respiratory distress and/or the presence of persistent or recurrent apnea and check of ABG for hypoxia or respiratory acidosis .</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Neonatal mortality. Timepoint: during hospitalization. Method of measurement: hospital documents.</sec_outcome>
      <sec_outcome>Duration of hospital stay. Timepoint: during of hospitalization. Method of measurement: hospital documents.</sec_outcome>
      <sec_outcome>The incidence of pneumothorax. Timepoint: till 72 hours after birth. Method of measurement: CXR.</sec_outcome>
      <sec_outcome>Pulmonary hemorrhage. Timepoint: till 72 hours after birth. Method of measurement: cilinical diagnosis and CXR.</sec_outcome>
      <sec_outcome>Number of rescue doses of  surfactant. Timepoint: till 48 hours after birth. Method of measurement: hospital documents.</sec_outcome>
      <sec_outcome>The incidence of chronic lung disease (CLD). Timepoint: till 36 weeks’ postnatal age. Method of measurement: oxygen requirement at 36 weeks’ postnatal age.</sec_outcome>
      <sec_outcome>Intraventricular hemorrhage (IVH). Timepoint: 7-14 days after birth. Method of measurement: brain sonography.</sec_outcome>
      <sec_outcome>Periventricular leukomalacia (PVL). Timepoint: between 36 and 40 weeks; postnatal age. Method of measurement: brain sonography.</sec_outcome>
      <sec_outcome>The incidence of retinopathy of prematurity. Timepoint: 4 weeks' of age and then every week till vascularization is completed. Method of measurement: eye exam.</sec_outcome>
      <sec_outcome>Duration of mechanical ventilation. Timepoint: during hospital stay. Method of measurement: hospital documents.</sec_outcome>
      <sec_outcome>Duration of need for oxygen. Timepoint: during hospital stay. Method of measurement: hospital documents.</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>Mazandaran University of Medical Siences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-03-02</approval_date>
        <contact_name>Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Vice-Chancellor for Research, Moalem sq., Sari, Mazandaran, Iran Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
