<?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>IRCT2013102315134N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-08</date_registration>
      <primary_sponsor>Vice chancellor for reasearch , Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Head covering effects on serm calcium during phototherapy</public_title>
      <acronym></acronym>
      <scientific_title>Head covering during phototherapy appropriate and safe method for Prevention of phototherapy-induced hypocalcaemia in icterus newborn with unaltered serum magnesium level.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14504</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Jaundice.</hc_freetext>
      <i_freetext>Intervention 1: Case group intervention: The occipital area of this group during phototherapy was covered by a hat. Calcium and magnesium levels were checked at the beginning, 48 hours after starting phototherapy, and 24  hours after the treatment. All the infants were placed under phototherapy with 8  Lamp, 40  watts, blue light with a wavelength of 470-410  nanometers, at a distance of 40 -30  cm from the body surface area. Calcium level equal to or less than 7.5  mg/dl was considered as hypocalcaemia  and Mg level equal to or less than 1.2  mg/dl was considered as hypomagnesaemia. White cabling Hat was used for newborns. Intervention 2: Control group intervention: Routine phototherapy was used for first group. Calcium and magnesium levels were checked at the beginning, 48  hours after starting phototherapy, and 24  hours after the treatment. All the infants were placed under phototherapy with 8 Lamp, 40  watts, blue light with a wavelength of 470-410  nanometers, at a distance of 40-30  cm from the body surface area.</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>Marzieh Kargar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand Street, Fatemeh Nursing and Midwifery College</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936-13119</zip>
        <telephone>+98 71 1647 4252</telephone>
        <email>kargarm@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Kargar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand Street, Fatemeh (PBUH) Nursing and Midwifery College</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936-13119</zip>
        <telephone>+98 71 1647 4252</telephone>
        <email>kargarm@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The major including criteria were : Full term;&#13;
Weighed more than 2500 grams; Had normal serum calcium; Apart from icterus; indirect bilirubin between13  to 18  mg/dl in full term neonates - their physical status was completely normal.   &#13;
 The major excluding criteria were: Asphyxia; respiratory distress; sepsis; hemolytic anemia; infants of mothers with diabetic or thyroid disorders.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>5 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>p50 , p51 </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Haemorrhagic and haematological disorders of fetus and newborn</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Case group intervention: The occipital area of this group during phototherapy was covered by a hat. Calcium and magnesium levels were checked at the beginning, 48 hours after starting phototherapy, and 24  hours after the treatment. All the infants were placed under phototherapy with 8  Lamp, 40  watts, blue light with a wavelength of 470-410  nanometers, at a distance of 40 -30  cm from the body surface area. Calcium level equal to or less than 7.5  mg/dl was considered as hypocalcaemia  and Mg level equal to or less than 1.2  mg/dl was considered as hypomagnesaemia. White cabling Hat was used for newborns.</i_keyword>
      <i_keyword>Control group intervention: Routine phototherapy was used for first group. Calcium and magnesium levels were checked at the beginning, 48  hours after starting phototherapy, and 24  hours after the treatment. All the infants were placed under phototherapy with 8 Lamp, 40  watts, blue light with a wavelength of 470-410  nanometers, at a distance of 40-30  cm from the body surface area.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bilirubin. Timepoint: The bilirubin level of each newborn were tested on arrival, 48  hours after phototherapy, and 24  hours following phototherapy. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Calcium. Timepoint: The calcium level of each newborn were tested on arrival, 48  hours after phototherapy, and 24  hours following phototherapy. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Magnesium. Timepoint: The calcium level of each newborn were tested on arrival, 48  hours after phototherapy, and 24  hours following phototherapy. Method of measurement: Blood sample.</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 reasearch , Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-11-21</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>7 floor,  Shiraz University of Medical Sciences building, Zand street Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
