<?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>IRCT20220211053998N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-02</date_registration>
      <primary_sponsor>Iranshahr University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Education based on Helping Babies Breathe Workshop Program for Midwives on the Neonatal asphyxia</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Education based on Helping Babies Breathe Workshop Program for Midwives on the Neonatal asphyxia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61903</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Asphyxia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Babies with asphyxia at birth: In this plan, in three consecutive periods of 6 months, the statistics of infants with asphyxia are collected according to the inclusion criteria (arterial blood test of the umbilical cord of newborns at birth, which is part of the hospital routine and neonatal Apgar score) in 6 months Second, midwives involved in birth, neonatal resuscitation program are trained and reminded 4 times according to a specific program, but in the first and third 6 months, no intervention is made in the field of midwifery education. Finally, the results and percentage of infants with asphyxia in these three time periods are compared and the effect of the outcome of continuing education is measured. Intervention 2: Intervention Group 2: Midwives: In the second 6 months of collecting statistics on asphyxiated infants, at the beginning of the first, third, fifth and sixth months, all midwives involved in birth are taught in person in the form of a workshop, neonatal resuscitation program and the effect of continuing education on educational outcomes (Statistics of asphyxiated infants) is measured (statistics of infants with asphyxia in the first 6 months, second 6 months and third 6 months are compared).</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 Our study is not over yet and there is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ferdows Bameri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran Hospital, 4 km of Bampour Road</address>
        <city>Iranshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9914665466</zip>
        <telephone>+98 54 3721 1490</telephone>
        <email>bameriferdows@bums.ac.ir</email>
        <affiliation>Iranshahr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ferdows Bameri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran Hospital, 4 km of Bampour Road</address>
        <city>Iranshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9914665466</zip>
        <telephone>+98 54 3721 2461</telephone>
        <email>bameriferdows@bums.ac.ir</email>
        <affiliation>Iranshahr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infants with Apgar Scores less than 7 in the fifth minute of life
Infants with a Potential Hydrogen(PH) less than 7 on umbilical Artery Blood Gas (ABG) Analysis in the first hour after Birth
Infants with a  Base excess (BE) less than -12 in Umbilical ABG Analysis in the first hour after Birth
Diagnosis of Hypoxic Ischemic Encephalopathy (HIE) in the first 3 Days after Birth
Multiple Organ Failure associated with HIE
Birth Age more than 34 Weeks
Born in Iran Hospital in Iranshahr</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Genetic Syndromes or Congenital Anomalies of the Central Nervous System at Birth</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R09.01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Asphyxia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Early detection</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Babies with asphyxia at birth: In this plan, in three consecutive periods of 6 months, the statistics of infants with asphyxia are collected according to the inclusion criteria (arterial blood test of the umbilical cord of newborns at birth, which is part of the hospital routine and neonatal Apgar score) in 6 months Second, midwives involved in birth, neonatal resuscitation program are trained and reminded 4 times according to a specific program, but in the first and third 6 months, no intervention is made in the field of midwifery education. Finally, the results and percentage of infants with asphyxia in these three time periods are compared and the effect of the outcome of continuing education is measured.</i_keyword>
      <i_keyword>Intervention Group 2: Midwives: In the second 6 months of collecting statistics on asphyxiated infants, at the beginning of the first, third, fifth and sixth months, all midwives involved in birth are taught in person in the form of a workshop, neonatal resuscitation program and the effect of continuing education on educational outcomes (Statistics of asphyxiated infants) is measured (statistics of infants with asphyxia in the first 6 months, second 6 months and third 6 months are compared).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of infants with asphyxia. Timepoint: Before intervention, during intervention, after intervention. Method of measurement: ABG test, Apgar score, clinical signs as determined by the treating physician or MRI.</prim_outcome>
      <prim_outcome>Degrees of asphyxia in infants. Timepoint: Before intervention, during intervention, after intervention. Method of measurement: ABG test, Apgar score, clinical signs as determined by the treating physician or MRI.</prim_outcome>
      <prim_outcome>Mean Apgar score of newborns. Timepoint: Before intervention, during intervention, after intervention. Method of measurement: Physical examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The average score of midwives participating in the continuing education program to helping babies breathe in the workshop. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Questionnaire 18 questions to assess the knowledge and OSCE tests of the program to helping babies breathe.</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>Iranshahr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-08</approval_date>
        <contact_name>Ethics committee of Iranshahr University of Medical Sciences</contact_name>
        <contact_address>No. 46, Imam Khomeini St., Iranshahr University of Medical Sciences Iranshahr Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
