<?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>IRCT2014070818406N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-31</date_registration>
      <primary_sponsor>Vice chancellor for research, shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effect of training attachment behavior to mother on physiological status and response to behavior preterm infants in the neonatal intensive care unit depend to shiraz  university of medical sciences in 2013</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of training attachment behavior to mother on physiological status and response to behavior preterm infants in the neonatal intensive care unit depend to shiraz university of medical sciences in 2013</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16708</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preterm infants.</hc_freetext>
      <i_freetext>Intervention 1: For the infants in the experimental group, training attachment behavior to mothers' of the infants are performed by the researcher. Body temperature, heart rate, respiratory rate, and blood oxygen saturation are measured. Physiological parameters to three times are measured: the first time half an hour before the exit to bed, 2: during intervention 3: half hour after entering to bed. Response behavior 2 hours before exit and 2 hours after enter checked by a   nurse who is kept uninformed about the study and its assumptions. To record the behavioral responses, the infant's face is captured in close-up during the after intervention and before intervention. The films are interpreted by an observer without knowledge of the intervention type. Finally, the changes in the physiological and behavioral parameters of the. Intervention 2: In the control group the method of training attachment are performed by nurses. Body temperature, heart rate, respiratory rate, and blood oxygen saturation are measured. Physiological parameters to three times are measured: the first time half an hour before the exit to bed, 2: during intervention 3: half hour after entering to bed. Response behavior 2 hours before exit and 2 hours after enter checked by a   nurse who is kept uninformed about the study and its assumptions. To record the behavioral responses, the infant's face is captured in close-up during the after intervention and before intervention. The films are interpreted by an observer without knowledge of the intervention type. Finally, the changes in the physiological and behavioral parameters of the.</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>Sahra Zendeh Zaban</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat-e-Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone></telephone>
        <email>zendehzaban@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences - Hazrat-e-Fatemeh Nursing and Midwifery Faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Edraki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat-e-Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1647 4257</telephone>
        <email>Mitraedraki@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences - Hazrat-e-Fatemeh Nursing and Midwifery Faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: gestational age of 32–36 weeks; postnatal age of 7-30 days; weight 1500-2500 grams; not using sedatives and short- or long-acting skeletal muscle relaxant drugs; not having substance abuse issues and no sedative drug use by the mother; no major congenital, chromosomal or neurological abnormalities;stability of physiological parameters in the infant; ability for oral breast feeding, and keep in incubator.&#13;
Exclusion criteria: need to ventilator in the infant; need to oxygen therapy; inability for oral breast feeding; using sedatives and short- or long-acting skeletal muscle relaxant drugsز; parents' unwillingness to continue cooperating in research.</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>1 month</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Prematurity NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For the infants in the experimental group, training attachment behavior to mothers' of the infants are performed by the researcher. Body temperature, heart rate, respiratory rate, and blood oxygen saturation are measured. Physiological parameters to three times are measured: the first time half an hour before the exit to bed, 2: during intervention 3: half hour after entering to bed. Response behavior 2 hours before exit and 2 hours after enter checked by a   nurse who is kept uninformed about the study and its assumptions. To record the behavioral responses, the infant's face is captured in close-up during the after intervention and before intervention. The films are interpreted by an observer without knowledge of the intervention type. Finally, the changes in the physiological and behavioral parameters of the</i_keyword>
      <i_keyword>In the control group the method of training attachment are performed by nurses. Body temperature, heart rate, respiratory rate, and blood oxygen saturation are measured. Physiological parameters to three times are measured: the first time half an hour before the exit to bed, 2: during intervention 3: half hour after entering to bed. Response behavior 2 hours before exit and 2 hours after enter checked by a   nurse who is kept uninformed about the study and its assumptions. To record the behavioral responses, the infant's face is captured in close-up during the after intervention and before intervention. The films are interpreted by an observer without knowledge of the intervention type. Finally, the changes in the physiological and behavioral parameters of the</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Temperature. Timepoint: First time half an hour before the exit from the bed, second time during intervention and third time half hour after entering to the bed. Method of measurement: Thermometer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: First time half an hour before the exit from the bed, second time during intervention and third time half hour after entering to the bed. Method of measurement: Pulse oximetry.</prim_outcome>
      <prim_outcome>Blood oxygen saturation. Timepoint: First time half an hour before the exit from the bed, second time during intervention and third time half hour after entering to the bed. Method of measurement: Pulse oximetry.</prim_outcome>
      <prim_outcome>Respiration rate. Timepoint: First time half an hour before the exit from the bed, second time during intervention and third time half hour after entering to the bed. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Behavioral responses. Timepoint: First time 2 hours before exit and second time 2 hours after entering to the bed(incubator). Method of measurement: Video camera.</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, shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-30</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>zand shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
