<?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>IRCT201407218315N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-18</date_registration>
      <primary_sponsor>Research Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of blanket and plastic wrap on the body temperature of premature infants.</public_title>
      <acronym></acronym>
      <scientific_title>Compare the effect of two methods of plastic wrap and blanket on body temperature, heart rate and oxygen saturation in preterm infants under radiant warmer: A randomized controlled cross over clinical trial single blind.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8768</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Effects of Covers on hypothermia.</hc_freetext>
      <i_freetext>Intervention 1: Infants in group 1 from 8 to 9 am for an hour of their neck down, covered with slipcover(over a period of time to wash out and relieve the effects of previous coverage) and then from 9 am until 8 am the next day for a period of 23 hours from the neck down covered with plastic wrap, then the same time, from 8 to 9 am for an hour from the neck to the bottom is covered with slipcover(over time wash out and gutting work intervention previous) then the baby from 9 am until 8 am the next day for a period of 23 hours, from the neck down covered with blanket(Technique routine is blanket. Technique Intervention is the use of plastic wrap. During the wash out is the use of slipcover). Intervention 2: Infants in group 2 from 8 to 9 am for an hour of your neck down, covered with slipcover(over a period of time to wash out and relieve the effects of previous coverage) and then from 9 am until 8 am the next day for a period of 23 hours from the neck down covered with a blanket, then the same time, from 8 to 9 am for an hour of your neck down, covered with slipcover(over time wash out and the destruction of intervention previous) then the baby from 9 am until 8 am the next day for a period of 23 hours, from the neck down covered with plastic wrap(Technique routine is blanket. Technique Intervention is the use of plastic wrap. During the wash out is the use of slipcover).</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>Maryam Peyghami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>south shariatist., Tabriz Faculty of Nursing and Midwifery</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 44 4632 4905</telephone>
        <email>kontroleofonateshahindezh@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Leila Valizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>south shariatist., Tabriz Faculty of Nursing and Midwifery</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>valizadehl@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Infants with 28 to 30 weeks of gestation, birth weight of 800 to 1250 grams, caring under the radiant warmer, being on the second or third day of birth, Respiratory care with Nasal CPAP or HFNC.&#13;
Exclusion criteria: neural tube defects, congenital skin diseases, congenital heart diseases, congenital malformations of abdominal wall (omphalocele, gastroschisis), diagnosis of neonatal sepsis, metabolic disorders, infants referred from other centers, surgery, Intrauterine growth retardation (IUGR) , born from mothers with fever(fever greater than 38.5 ° C), died during the study, discharged during the study (with personal satisfaction), being under ventilation, lack of parental consent to continue study, phototherapy, exchange blood, body temperature greater than 38 and less than 36 °C , heart rate less than 70 and more than 200, arterial oxygen saturation less than 80%.</inclusion_criteria>
      <agemin>7 months</agemin>
      <agemax>7 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P81.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disturbance of temperature regulation of newborn, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Infants in group 1 from 8 to 9 am for an hour of their neck down, covered with slipcover(over a period of time to wash out and relieve the effects of previous coverage) and then from 9 am until 8 am the next day for a period of 23 hours from the neck down covered with plastic wrap, then the same time, from 8 to 9 am for an hour from the neck to the bottom is covered with slipcover(over time wash out and gutting work intervention previous) then the baby from 9 am until 8 am the next day for a period of 23 hours, from the neck down covered with blanket(Technique routine is blanket. Technique Intervention is the use of plastic wrap. During the wash out is the use of slipcover).</i_keyword>
      <i_keyword>Infants in group 2 from 8 to 9 am for an hour of your neck down, covered with slipcover(over a period of time to wash out and relieve the effects of previous coverage) and then from 9 am until 8 am the next day for a period of 23 hours from the neck down covered with a blanket, then the same time, from 8 to 9 am for an hour of your neck down, covered with slipcover(over time wash out and the destruction of intervention previous) then the baby from 9 am until 8 am the next day for a period of 23 hours, from the neck down covered with plastic wrap(Technique routine is blanket. Technique Intervention is the use of plastic wrap. During the wash out is the use of slipcover).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determination and comparison of the body temperature, heart rate and arterial oxygen saturation. Timepoint: One hour before and after the washout period, then every three hours for 12 hours. Method of measurement: Digital thermometer and monitoring devices.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complications, each of the covering. Timepoint: Every three hours during the 48 hours of study time. Method of measurement: observation, digital thermometers, control devices.</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>Research Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Tabriz University of Medical Sciences</contact_name>
        <contact_address>Azadi Street, Golgasht Street, Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
