<?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>IRCT201604084613N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-31</date_registration>
      <primary_sponsor>Vice Chancellor of Resreach of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The impact of mother education on Maternal Self Efficacy and Newborn Discharge Preparation</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Designed Empowerment Program on Maternal Self Efficacy and Newborn Discharge Preparation from Neonatal Intensive Care Units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4939</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: There was not possibility of random allocation of mothers to groups, due to the possible exchange of educational content between mothers. Therefore, at first, we will choice one of the groups to the desired number by Non Parallel sampling, and then, was selected Group B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Disorders related to short gestation and low birth weight.</hc_freetext>
      <i_freetext>Intervention 1: In the control group, usual care (which includes Kangaroo mother care and breast feeding), through face-to-face training will be taught to mothers by department nurses. Intervention 2: In the intervention group, mothers in addition to usual care (including learning Kangaroo mother care and breast feeding), the intervention is designed (empowerment program) will be taught by the investigator as step by step by investigator. This program include frequent hand washing with disinfectant solution, touch and infant massage, kangaroo mother care (KMC), preparation and storage of milk, baby sucking practice with pacifier or finger and then with breast, education correct breast feeding and burping the baby, the number of infant feeding, bathing and changing diapers and according to the baby's prematurity or medical conditions; The first time mentioned practices is down by the investigator in the presence mother and along education about how it can be done and next time, if the mother skill for its approved by a colleague, care will be conducted by his mother and under the supervision of a researcher. In addition to face to face training, they are given a training manual booklet and a multimedia electronic files (CD), if it is possible, mothers study at the earliest opportunity before beginning any training.</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>Shahla Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza (AS) Hospital, next to the Faculty of Medical Sciences, Street Sorkhe Lyzhh, University Square, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>67157- 46143</zip>
        <telephone>+98 83 3441 1173</telephone>
        <email>shahlamoradi58@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery, Tabriz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sousan Valizadeh Dehkhargani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>PhD in Nursing Education</address>
        <city>Nursing &amp; Midwifery Faculty, South Shriaty Street, Tabriz, IRAN.</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>44199-51668</zip>
        <telephone>+98 41 3479 0364</telephone>
        <email>valizades@tbzmed.ac.irvalizadehsousan13@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for mothers: having a minimum of guidance secondary school literacy and more; with Minimum age 20 and more; no history of preterm birth in a previous pregnancy; no history of hospitalization in previous children in neonatal intensive care unit; not having preeclampsia or other diseases that require needs for long term hospitalization and completed the informed consent.&#13;
Inclusion criteria for Newborns: birth weight between 2500 to 1000 grams; gestational age between 28 -34 weeks; No anomaly major congenital and major physical illnesses; the absence of neurological defects including seizures; intraventricular hemorrhage with a higher degree of 2 and periventricular Leukomalacia.&#13;
Exclusion criteria: In case of infant death; In case of infant referring to other centers for treatment continue; Mother withdrew from participation in the study; not mothers participating in the study; mother absence of company training sessions, in case of failure to respond to 20% of questions of the questionnaire.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.1, P07</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders related to short gestation and low birth weight, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the control group, usual care (which includes Kangaroo mother care and breast feeding), through face-to-face training will be taught to mothers by department nurses.</i_keyword>
      <i_keyword>In the intervention group, mothers in addition to usual care (including learning Kangaroo mother care and breast feeding), the intervention is designed (empowerment program) will be taught by the investigator as step by step by investigator. This program include frequent hand washing with disinfectant solution, touch and infant massage, kangaroo mother care (KMC), preparation and storage of milk, baby sucking practice with pacifier or finger and then with breast, education correct breast feeding and burping the baby, the number of infant feeding, bathing and changing diapers and according to the baby's prematurity or medical conditions; The first time mentioned practices is down by the investigator in the presence mother and along education about how it can be done and next time, if the mother skill for its approved by a colleague, care will be conducted by his mother and under the supervision of a researcher. In addition to face to face training, they are given a training manual booklet and a multimedia electronic files (CD), if it is possible, mothers study at the earliest opportunity before beginning any training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal Self Efficacy. Timepoint: Baseline (within 1-2 days after admission in NICU) and 1 to 2 days before infants hospital discharge (18 days). Method of measurement: Maternal Self-Efficacy will be measured by Preterm Parenting &amp; Self-Efficacy Checklist That was developed by Pennel and colleagues in 2012. This checklist, will be measured maternal self-efficacy of premature infants in three dimensions the mother's confidence in performing tasks, understand the importance of tasks for mothers and mothers competence (the sense of achievement) with 36 questions. The total range of self-efficacy score will be between: 36-252 and between: 12-84 for each dimension. If score was less than 48, maternal self-efficacy reported as undesirable and if score was more than 48 will be reported as desirable.</prim_outcome>
      <prim_outcome>Preparation discharge. Timepoint: Baseline (within 1-2 days after admission in NICU) and 1 to 2 days before infants hospital discharge (18 days). Method of measurement: Preparation discharge checklist was measured, that was made by Dashti and colleagues, with review of the literature. This checklist include 28 items with a score of zero and one with 12 questions about the physical condition and general health of the infant at discharge and 16 questions about the training provided to mother.</prim_outcome>
      <prim_outcome>Maternal satisfaction. Timepoint: Baseline (within 1-2 days after admission in NICU) and 1 to 2 days before infants hospital discharge (18 days). Method of measurement: Mothers' satisfaction, with facilities, nursing care and medical care was measured through a modified pediatric family satisfaction questionnaire (PFSQ), which is modified by Saidi et al. This questionnaire include 13 questions on a Likert scale score (1-5).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The rate of hospital readmission. Timepoint: 15 days after discharge from the hospital. Method of measurement: Through a phone call with her mother.</sec_outcome>
      <sec_outcome>The length of infant’ stay (day) at hospital. Timepoint: At the infant discharge from the hospital. Method of measurement: The length of infant’ stay in NICU (day) at discharge time will be recorded in the data collection form.</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 of Resreach of Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-06</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Vice Chancellor for Research and Technology of Tabriz University of Medical Sciences, Golgasht St, Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
