<?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>IRCT20180718040513N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-25</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>effect of  maternal attachment behaviors  on the health of premature infants</public_title>
      <acronym>neonatal intensive care unit : NICU</acronym>
      <scientific_title>The effect of teaching attachment behaviors to mothers on the short-term health consequences of premature infants in NICUs.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32850</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Each of the maternal infants who enter the study is randomly assigned a number, these numbers are randomly distributed among the questionnaires and the units are assigned to the intervention and control groups based on the number received, Blinding description: Mothers do not notice the presence of evaluators, and the checklist for the groups is encrypted with a code and the evaluator is blind to the groups. The data analysis is performed by a statistician who has no information about the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mother and neonate attachment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Attachment behaviors are taught to mothers of the intervention group, Maximum 48 hours after admission for 4 sessions, once a day and each session 20 -30 minute, face to face and on the neonate bedside. the content of education are Familiarity with neonatal care environment and equipment for the newborn, appearance and behavioral characteristics of premature neonates and behaviors related to attachment (emotional, Neighborhood, Care). Intervention 2: Control group: routine care.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The demographic characteristics of the samples, such as age, level of education, etc., Also information on the main outcome of the study are published in the form of a dissertation

When:
Immediately after publishing the results in dissertation form

To whom:
Data is accessible to the general public

Conditions:
Data is accessible to the general public. The application is submitted electronically only by email: m2ghanbari@yahoo.com

Where to obtain:
E.Mail: m2ghanbari@yahoo.com; arzaniaf@gmail.com
nursing and midwifery faculty, Babol University of Medical Sciences

How to obtain:
The applicant will be provided electronically about a month after submitting the application

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojtaba Qanbari qalesari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol university of medical science- nursing faculty</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۷۱۷۶-۴۷۷۴۵</zip>
        <telephone>+98 11 3219 9592</telephone>
        <email>m2ghanbari@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojtaba Qanbari qalesari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol university of medical science- nursing faculty</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۷۱۷۶-۴۷۷۴۵</zip>
        <telephone>+98 11 3219 9592</telephone>
        <email>m2ghanbari@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers who able to read and write
Neonates with birth weight&lt; 1500
neonates with apgar scor&gt;7</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Mothers who are  physical and mental ill
the prohibition on mothers breastfeeding
Mothers  addiction to drugs and alcohol
neonates with congenital anomalies</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>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Attachment behaviors are taught to mothers of the intervention group, Maximum 48 hours after admission for 4 sessions, once a day and each session 20 -30 minute, face to face and on the neonate bedside. the content of education are Familiarity with neonatal care environment and equipment for the newborn, appearance and behavioral characteristics of premature neonates and behaviors related to attachment (emotional, Neighborhood, Care)</i_keyword>
      <i_keyword>Control group: routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of full oral feeding in both groups;. Timepoint: From admission to full oral feeding. Method of measurement: From the beginning of the first oral feeding of the neonate, according to the physician's order, until the neonate is able to fully nourish it (feeding without gavage).</prim_outcome>
      <prim_outcome>Neonate weight. Timepoint: at the time of admission and discharge. Method of measurement: using the standard digital weighing scale.</prim_outcome>
      <prim_outcome>Duration of admission. Timepoint: from admission until discharge. Method of measurement: Calculate the number of days the newborn is admitted to the hospital, from the time of admission to the date of the doctor's order for the discharge of the baby.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mother's attachment. Timepoint: At the time of admission and discharge. Method of measurement: Avant attachment behavior scale.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-05</approval_date>
        <contact_name>National Research Ethics Committee</contact_name>
        <contact_address>Mazandaran, Babol, Babol University of Medical Sciences, Health Research Cente Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
