<?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>IRCT201508248801N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-31</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of parents education on knowledge، altitude، practice and patterns of breastfeeding.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of parents education on knowledge، altitude، practice and patterns of breastfeeding until four month.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9291</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>3</phase>
      <hc_freetext>P92.5 Neonatal difficulty in feeding at breast.</hc_freetext>
      <i_freetext>Intervention 1: Two 40-minute sessions Within a week of training That includes an explanation about the benefits of breastfeeding and how to properly breastfeed As well as face to face and direct training to mother and training to fathers on how to help encourage breastfeeding and help mother in planning or participating in other activities to provide time off for breast-feeding mother at night. Intervention 2: Breast-feeding mothers in the control group is training as usual. Fathers are not in this band.</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>Farideh Panahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 4 , Zarin building, No.9, 6th Street, 1St block, 3rd phase, Gohardasht</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Iran</zip>
        <telephone>+98 26 3442 7513</telephone>
        <email>f.panahi53@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Simbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery faculty of Shahid Behshti, Research Department</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8865 5378</telephone>
        <email>msimbar@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria for mothers: Being Iranian; Speaking in Persian; residency in Karaj city; literacy; Being nulliparous; No known medical conditions and mental illness; birth of a singleton and Healthy infant; have no obstacle for infant,  breastfeeding.&#13;
Inclusion Criteria for Fathers: Being Iranian;  Speaking in Persian; residency in Karaj city; literacy.&#13;
Exclusion criteria for participation: Unwillingness to continue cooperation with researcher; Hospitalization of the infant or mother for medical condition; Death of relatives in a period of study; Parents' separation  from baby; Taking contraindicated medicines for breastfeeding by mothers; Death of infant; not start feeding baby with breast milk during the first visit; Use of pacifiers; Unwanted pregnancy.</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>49 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P92.5 Neon</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal difficulty in feeding at breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Two 40-minute sessions Within a week of training That includes an explanation about the benefits of breastfeeding and how to properly breastfeed As well as face to face and direct training to mother and training to fathers on how to help encourage breastfeeding and help mother in planning or participating in other activities to provide time off for breast-feeding mother at night.</i_keyword>
      <i_keyword>Breast-feeding mothers in the control group is training as usual. Fathers are not in this band.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge. Timepoint: Before intervention and Four month after the training intervention. Method of measurement: Assess parents' knowledge about Breastfeeding Questionnaire.</prim_outcome>
      <prim_outcome>Atittude. Timepoint: Before intervention and Four month after the training intervention. Method of measurement: Assess parents' Attitude about Breastfeeding Questionnaire.</prim_outcome>
      <prim_outcome>Practice. Timepoint: Before intervention and Four month after the training intervention. Method of measurement: Assess parents' Performance -behavior about Breastfeeding Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Vice chancellor for research, Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-01</approval_date>
        <contact_name>Ethical commitee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Medical Sciences University of Shahid Beheshti Nursing and Midwifery faculty of Shahid Behshti, Vali Asr intersection prayer in front of the Rajai Hospital Beheshti Department of Nursing and Midwifery Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
