<?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>IRCT2015120825439N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-21</date_registration>
      <primary_sponsor>Birjand University of Medica Sciences</primary_sponsor>
      <public_title>Efficacy of zincsulfate in icter</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of zinc sulfate in reducing unconjugated hyperbilirubinemia in premature neonate in NICU</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21277</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>indirect hyperbilirubinemia.</hc_freetext>
      <i_freetext>Intervention 1: all of neonate will treat with photothrapy.neonate in sulfate group reciecive 1mg/kg (5mg/5cc)zincsulfate more than photo.prescription is oral with syrang and every 6 hours until the end of phototherapy.measurment of the level of bilirubin is the bigining of admission then 6 hours after that and then daily. Intervention 2: In control group neonatewill recieve 1mg/kg placebo(sucrose) more than photo.prescription is oral with syrang and every 6 hours until the end of phototherapy.measurment of the level of bilirubin is the bigining of admission then 6 hours after that and then daily ,.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Abstract&lt;br /&gt;&#13;
Introduction and Aim: Ichter and hyperbilirubinemia are common and, in most cases, benign problems in infancy. Ichter occurs in about 60% of the term and 80% of preterm infants during the first weeks of life. Several studies conducted on the impact of zinc salts on indirect serum bilirubin levels in newborns have shown different results, all of which have called for further research. The aim of this study was to determine the effect of zinc sulfate on indirect hyperbilirubinemia in premature infants admitted to the NICU.&lt;br /&gt;&#13;
Materials and methods: As a randomized, double-blind, clinical trial, this study was conducted in the NICU of Vali-e-Asr Hospital. The population consisted of premature infants admitted to the NICU of Vali-e-Asr Hospital. The sample included 60 infants who were randomly assigned into intervention and control groups (n=30 per group). While both groups underwent phototherapy, the intervention group received 1 cc/kg zinc sulfate syrup (containing 5 mg/5cc zinc sulfate) whereas the control group was given 2 cc/kg placebo syrup (containing sucrose) simultaneously. Assessment was made at the time of hospitalization, 6 hours later, and on a daily basis. The data were analyzed in SPSS software (version 21) using descriptive (mean, standard deviation, frequency and percentage) and inferential statistical tests (independent t-test, ANOVA, post hoc Bonferroni test, and Mann-Whitney test). P values less than or equal to 0.05 were considered significant.&lt;br /&gt;&#13;
Findings: The study included 30 infants in the intervention group and 30 infants in the control group. There were not significant differences between the two groups in terms of gender, mean birth age at the start of phototherapy, and gestational age. Changes in bilirubin levels, respectively in intervention and control groups, 6 hours after treatment were -1.45±3.23 and -0.49±0.37 (P=0.024): at 24 hours, -3.26±2.78 and -1.89±1.20 (P0.017); and at 48 hours, -4.89±2.76 and -3.98±2.32 (P=0.23). Phototherapy time had no significant difference between the two groups (P=0.24).&lt;br /&gt;&#13;
Conclusion: The results of this study showed that application of zinc sulfate syrup in premature infants with indirect hyperbilirubinemia within 48 hours of starting treatment could substantially reduce bilirubin levels.&lt;br /&gt;&#13;
Key Words: Ichter; Premature Infants; Zinc Sulfate&lt;br /&gt;&#13;
</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>Gholamreza Faal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Hospital</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3244 3005</telephone>
        <email>grfal@yahoo.com</email>
        <affiliation>Birjand University of Medical  Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholam Reza Faal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghafari aveniue</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3244 3005</telephone>
        <email>grfal@yahoo.com</email>
        <affiliation>Birjand University of  Medical  Uciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria:premature neonate with GA30-37week;weight1500-2500                         exclusion criteria:hemolysis; o sepsis;abnormality;dehydration;G6PD;ABOmissmatch;positive coombs;history of consumption phenobarbital by mother;IUGR;ventilation;NPO</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>1 month</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P59.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal jaundice associated with preterm delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>all of neonate will treat with photothrapy.neonate in sulfate group reciecive 1mg/kg (5mg/5cc)zincsulfate more than photo.prescription is oral with syrang and every 6 hours until the end of phototherapy.measurment of the level of bilirubin is the bigining of admission then 6 hours after that and then daily</i_keyword>
      <i_keyword>In control group neonatewill recieve 1mg/kg placebo(sucrose) more than photo.prescription is oral with syrang and every 6 hours until the end of phototherapy.measurment of the level of bilirubin is the bigining of admission then 6 hours after that and then daily ,</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of bilirubin. Timepoint: 6hours/24hours/48hours. Method of measurement: mg/dl.</prim_outcome>
      <prim_outcome>Time of phototherapy. Timepoint: 6hours/24hours/48hours. Method of measurement: hour.</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>Birjand University of Medica Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-10-31</approval_date>
        <contact_name>Birjand University of Medical Sciences</contact_name>
        <contact_address>ghafari aveniue Birjand  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
