<?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>IRCT20181121041718N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-16</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Home Visit Program based on the Continued kangaroo Mother Care on Maternal Resiliency and Development of Premature Infant</public_title>
      <acronym>KMC</acronym>
      <scientific_title>The effect of Home Visit Program based on the Continued kangaroo Mother Care on Maternal Resiliency and Development of Premature Infant</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35511</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: This study is a randomized clinical trial with control group. In this research, sampling (inclusion of mothers and their neonates in the study) is carried out in a non-randomized manner. The allocation of the research units to intervention and control groups was based on randomized blocking method; that is, six scenarios are created for a four-block allocation in the first place, and then drawing lots is performed in order to arrange the blocks, Blinding description: The analyst will be unaware of the intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Maternal resilience and the development of preterm infants receiving maternal and neonatal care through home visits.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Premature babies are between 26-32 weeks old weighing more than 1000 grams. They are admitted to the neonatal intensive care unit and have criteria for entering the study, and after the removal of the newborn from advanced mechanical ventilation and finding the conditions for caring for kmc up to the minimum daily clearance Three times kmc surveillance takes place for 30-40 minutes, and they continue to care for a month at the home after a discharge. At the beginning of the arrival of the mothers, the intervention group will be completed by the maternity ward, the time of discharge, and one month after the discharge of the Conor Davidson resiliency scale. At 2 months of age, the modified age of the newborn will be evaluated evolutionally. Intervention 2: Control group: Premature babies are between 26-32 weeks old weighing more than 1000 grams. They are admitted to the neonatal intensive care unit and have criteria for entering the study, and after the removal of the newborn from advanced mechanical ventilation and finding the conditions for caring for kmc up to the minimum daily clearance Three times, they perform kangaroo care for 30-40 minutes and receive routine care after discharge. At the beginning of the arrival of the mothers, the intervention group will be completed by the maternity ward, the time of discharge, and one month after the discharge of the Conor Davidson resiliency scale. At 2 months of age, the modified age of the newborn will be evaluated evolutionally.</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 total potential data can be shared after unidentifiable people

When:
Start the access period 6 months after printing the results

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
The data can be used for other human research and health centers

Where to obtain:
Library of the School of Nursing and Midwifery of Mashhad, ghazim3@mums.ac.ir

How to obtain:
Visit the Library of Nursing and Midwifery Faculty of Mashhad

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marziye ghazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad, Ebne sina St, Nursing and Midwifery Faculty</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Ghazim3@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zare Masoud</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad, Ebne sina St, Nursing and Midwifery Faculty</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 913 791 3199</telephone>
        <email>Zaremd@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infant: Weight greater than or equal to 1000 g
Gestational age 26 to 32 weeks
Stable clinical situation
Failure to receive oxygen in an aggressive way
No anomaly based on the file
Non intraventricular hemorrhage grade 3 or 4
No need for advanced neonatal resuscitation during hospitalization
Mother: No known mental disorders
Resident in Mashhad or Mashhad suburb
Not addiction based on self-declaration
There is no significant family challenge with the husband, based on self-declaration.
Do not have twin or multiple delivery
There is no history of premature baby birth</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>7 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Infant: Respiratory instability and need for aggressive mechanical ventilation
Baby death
Occurrence of significant stressful events during research
Having chronic physical or mental illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other preterm infants - 28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Premature babies are between 26-32 weeks old weighing more than 1000 grams. They are admitted to the neonatal intensive care unit and have criteria for entering the study, and after the removal of the newborn from advanced mechanical ventilation and finding the conditions for caring for kmc up to the minimum daily clearance Three times kmc surveillance takes place for 30-40 minutes, and they continue to care for a month at the home after a discharge. At the beginning of the arrival of the mothers, the intervention group will be completed by the maternity ward, the time of discharge, and one month after the discharge of the Conor Davidson resiliency scale. At 2 months of age, the modified age of the newborn will be evaluated evolutionally.</i_keyword>
      <i_keyword>Control group: Premature babies are between 26-32 weeks old weighing more than 1000 grams. They are admitted to the neonatal intensive care unit and have criteria for entering the study, and after the removal of the newborn from advanced mechanical ventilation and finding the conditions for caring for kmc up to the minimum daily clearance Three times, they perform kangaroo care for 30-40 minutes and receive routine care after discharge. At the beginning of the arrival of the mothers, the intervention group will be completed by the maternity ward, the time of discharge, and one month after the discharge of the Conor Davidson resiliency scale. At 2 months of age, the modified age of the newborn will be evaluated evolutionally.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience of mothers of premature infants. Timepoint: The newborn is admitted to the infant's care unit, when the baby is given discharge, one month after the discharge. Method of measurement: Connor Davidson Questionnaire(2003).</prim_outcome>
      <prim_outcome>Premature infants development. Timepoint: 2 months old corrected age. Method of measurement: Development questionnaire ASQ.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-01</approval_date>
        <contact_name>The Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>University Street, Avicenna Street, Faculty of Nursing and Midwifery mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
