<?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>IRCT201111298251N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-07-25</date_registration>
      <primary_sponsor>Tehran University of Medical Science</primary_sponsor>
      <public_title>Effect of nesting position on stress</public_title>
      <acronym></acronym>
      <scientific_title>Effect of nesting position on stress motor behaviors in preterm infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8675</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stress.</hc_freetext>
      <i_freetext>Intervention 1: In evening shift of first day and before nesting position, the researcher videotapes behaviors for 20 minutes continued. Through recording, infant is in the incubator in prone position just with a diaper and small pad under the shoulder. The researcher records infants' posture and movements. Experimental group are put into the nest for seven days. Nests are oval shaped cloth with boundaries in both sides that also surrounds feet. It's size is chosen according to the infants weight. The positioning program through nesting will be taught to the nurses. Throughout this period, the infant can remove from the nest, for weighting, breastfeeding, bathing and other cares. After seven days nest is removed and 20 minutes recording of infants will be done, in such before. The researcher  review the films for count and comparing total stress motor behaviors. Intervention 2: In the control group, in the evening shift of first day, the researcher videotapes behaviors for 20 minutes continued. Through recording, infant has laid in the incubator in prone position and dressed in a diaper with small pad under the shoulder. The researcher records infants' posture and movements. One week later, they will be filmed in such before. In these seven days he/she will gain routine nursing cares. The researcher  review the films for count and comparing total stress motor behaviors. The researcher review the films for count and comparing total stress motor behaviors.</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>Zahra Eskandari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>zeskandari87@yahoo.com, z-eskandari@razi.tums.ac.ir</email>
        <affiliation>Tehran Nursing and Midwifery Faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Naima Seyedfatemi, Dr Parisa Mohagheghi, Dr. Heidelise Als</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00982166927171, 00982166514001</telephone>
        <email>Nseyedfatemi@yahoo.com, Pmohagh@yahoo.com, Heidelise.als@childrens.harvard.edu</email>
        <affiliation>Tehran Nursing and Midvifery Fafulty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Birth weight:1000-1500 gr.; Gestational  age at birth of 30 weeks to 33 weeks 6 days(&lt;34weeks) after mother's last menstrual period; Being in secondary week postnatal age; Resting into the incubator; absence of congenital or chromosomal abnormality, IUGR, or other anomalies like clavicle fracture, hip or limb deformities.&#13;
 exclusion criteria: substance abuse in mothers; Intra ventricular hemorrhage(3 ,4 degree)that recognized by brain ultrasound; Sepsis; NPO, any invasive ventilation, prescription Phenobarbital or phenytoin till end of the program.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>1 year</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43, F43.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>F43:Reaction to severe stress, and adjustment disorders-F43.0 :Acute stress reaction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In evening shift of first day and before nesting position, the researcher videotapes behaviors for 20 minutes continued. Through recording, infant is in the incubator in prone position just with a diaper and small pad under the shoulder. The researcher records infants' posture and movements. Experimental group are put into the nest for seven days. Nests are oval shaped cloth with boundaries in both sides that also surrounds feet. It's size is chosen according to the infants weight. The positioning program through nesting will be taught to the nurses. Throughout this period, the infant can remove from the nest, for weighting, breastfeeding, bathing and other cares. After seven days nest is removed and 20 minutes recording of infants will be done, in such before. The researcher  review the films for count and comparing total stress motor behaviors.</i_keyword>
      <i_keyword>In the control group, in the evening shift of first day, the researcher videotapes behaviors for 20 minutes continued. Through recording, infant has laid in the incubator in prone position and dressed in a diaper with small pad under the shoulder. The researcher records infants' posture and movements. One week later, they will be filmed in such before. In these seven days he/she will gain routine nursing cares. The researcher  review the films for count and comparing total stress motor behaviors. The researcher review the films for count and comparing total stress motor behaviors.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total stress motor behaviors. Timepoint: Befor intervention, One week after intervention. Method of measurement: Als's behavior observation(standard).</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>Tehran University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-06-09</approval_date>
        <contact_name>Tehran University of Medical Science</contact_name>
        <contact_address>Research Center, Ghods Ave, Keshavarz Blvd Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
