<?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>IRCT20190810044491N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-08</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing Efficacy of Chest Tube  drainage and Needle Aspiration for Pneumothorax Treatment in neonates</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the efficacy and safety of needle aspiration and intercostals tube draining, in management of neonatal pneumothorax that receiving assisted ventilation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>116</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41462</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study was used permuted block randomization. Pateints assigned 2 groups: group A (chest tube method) and group B (Needle Aspiration). Two possible combinations were created for groups AB and BA. Then one of these compounds was randomly selected. This process was repeated several times to obtain the required sample size.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pneumothorax, Chest Tube, Needle Aspiration,.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (needle aspiration method): In this group (48 neonates), The thoracentesis was done by aspiration of air using a 10 to 20 cc syringes with a 23 to 25-gauge or 18 to 24 angiocath from the second or third intercostal space and precisely at the top of the rib (to prevent blood vessel damage) in the midclavicular line. Intervention 2: Control group(chest tube method): in this group (68 neonates), Thoracostomy was performed using the chest tube technique by insertion of 10-12F tubes after prep &amp; drep and local anesthesia. A small incision was made at the mid-axillary line of the sixth intercostal space.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zinat Shakery</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 193,  Zafar St, Modares Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2304 6253</telephone>
        <email>zinatshakeri@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zinat Shakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.193, Vahid Dastgerdi St, Modares Highway, Aliasghar Children Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2304 6253</telephone>
        <email>zinatshakeri@yahoo.com</email>
        <affiliation>Iran 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>Parent's consent to participate in the study
Aged lower than 28 day
Neonates with respiratory support (including endotracheal tube or CPAP or requires more than 40% oxygen) and chest pneumothorax were diagnosed by a physician who were hospitalized in NICU ward</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>28 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No parent's consent
Tension pneumothorax or emergency draining before x-ray
Lung hypoplasia
Congenital heart disease
Meconium Aspiration Syndrome (MAS)
Congenital Anomalies
peters syndrome
pleural effusion</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J93</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pneumothorax</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (needle aspiration method): In this group (48 neonates), The thoracentesis was done by aspiration of air using a 10 to 20 cc syringes with a 23 to 25-gauge or 18 to 24 angiocath from the second or third intercostal space and precisely at the top of the rib (to prevent blood vessel damage) in the midclavicular line.</i_keyword>
      <i_keyword>Control group(chest tube method): in this group (68 neonates), Thoracostomy was performed using the chest tube technique by insertion of 10-12F tubes after prep &amp; drep and local anesthesia. A small incision was made at the mid-axillary line of the sixth intercostal space</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Successful treatment rate. Timepoint: Before and after draining of pneumothorax. Method of measurement: X-ray and physical examination (neonatologist).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complications related to the procedures (mortality rate, need for invasive and noninvasive ventilation, blood culture and CRP results, duration of antibiotic use and length of hospitalization, ). Timepoint: After draining of  pneumothorax. Method of measurement: Physical examination and laboratory test.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-19</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Siences</contact_name>
        <contact_address>No. 193,  Modares Highway, Vahid Dastgerdy st, Aliasghar Children Hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
