<?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>IRCT20190622043966N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-02</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Skin -to-Skin Contact Education</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Mother-Newborn Skin-to-skin  Contact Education during first two months of newborn life on Exclusive Breastfeeding</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40380</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Blocking :At the beginning of the project ، based on the random four - way blocking method ، the pocket will be provided to the researcher ، which at the beginning of each day will open one of them without disturbing ، and the letter contained in the envelope will be based on the contract. The previous one will show that the patients will be in the intervention group(Skin -to -SKIN contact Education )that day ، or in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Skin-to- skin contact and its effects on exclusive breastfeeding.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Maternal and infant Skin -to- Skin  contact  Education   during the first two months of life at least 1 hour per day in two first months. Intervention 2: Control group:no training in the field of benefit skin-to-skin contact.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>leila Elmi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>خیابان  دستغیب مرکز بهداشت غرب تهران کلینیک ولفجر</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1444643961</zip>
        <telephone>+98 66512396</telephone>
        <email>elmi12leila@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sadr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dastgeib Street, West of Tehran Health Center, Valfajr Clinic</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1444643961</zip>
        <telephone>+98 21 6651 2396</telephone>
        <email>elmi12leila@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All Mother  and Newborn in 3 to 5 day from life of newborn  that refer to valfajre clinic</inclusion_criteria>
      <agemin>3 days</agemin>
      <agemax>5 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Illiterate mothers
Mothers with conditions and disease that are contraindications to breastfeeding .Includes :Psychiatric disorders ، substance abuse ،active infectious disease such as TB and AIDS ،and the use of drugs to prevent lactation such as chemotherapy drugs
Infants with conditions and disease that are contraindications to breastfeeding .includes :Cleft palate، Galactosemia ، Phenylketonuria</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Maternal and infant Skin -to- Skin  contact  Education   during the first two months of life at least 1 hour per day in two first months</i_keyword>
      <i_keyword>Control group:no training in the field of benefit skin-to-skin contact</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Exclusive Breastfeeding. Timepoint: 3 to 5 days and end of first two months of life. Method of measurement: Self-declaration.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Baby crying rate. Timepoint: 3 to 5 days and end of first two months of life. Method of measurement: Self-declaration.</sec_outcome>
      <sec_outcome>Baby Sleep Rates. Timepoint: 3 to 5 days and end of first two months of life. Method of measurement: Self-declaration.</sec_outcome>
      <sec_outcome>Quality of life for mothers. Timepoint: 3 to 5 days and end of first two months of life. Method of measurement: SF-12 questionnaire.</sec_outcome>
      <sec_outcome>Weight at 2 months. Timepoint: 3 to 5 days and end of first two months of life. Method of measurement: Digital scales.</sec_outcome>
      <sec_outcome>Height at 2 months. Timepoint: 3 to 5 days and end of first two months of life. Method of measurement: Height gauge.</sec_outcome>
      <sec_outcome>Head circumcision. Timepoint: 3 to 5 days and end of first two months of life. Method of measurement: centimeter.</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>2019-06-10</approval_date>
        <contact_name>Iranian Nationl Comitee for ethics in biomedical research</contact_name>
        <contact_address>Dashegib Street, West of Tehran Health Center, Valfajr Clinic Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
