<?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>IRCT2016060428188N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-26</date_registration>
      <primary_sponsor>Vice chancellor for research, Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The investigation of theraputic effect of Cotoneaster drops on neonatal hyperbiirubinemia</public_title>
      <acronym>-</acronym>
      <scientific_title>Assessment of the effect of Cotoneaster drops in management of neonatal hyperbilirubinemia: a clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22923</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Using blocking method, Randomization description: A computer software program is used to produce random numbers to allocate the medication and placebo to four groups, Blinding description: Group 1: The neonate with jaundice and the mother receive placebo. Group 2: The neonate with jaundice and the mother receive cotoneaster drops. Group 3: The neonate with jaundice receives cotoneaster drops and the mother receives placebo. Group 4: The infant with jaundice receives placebo and the mother receives cotoneaster drops.</study_design>
      <phase>2</phase>
      <hc_freetext>Neonatal jaundice.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 (Control): The neonate with jaundice and mother will receive placebo. The neonate with jaundice will receive placebo drops per day is similar to the number of cotoneaster drops. The mother will receive number of placebo drops per day is similar to the number of cotoneaster drops. Intervention 2: Intervention group 2: The neonate with jaundice and the mother both will receive cotoneaster drops. Mothers will receive 5 ml of cotoneaster drops every 8 hours for 5 days. Neonate will receive amount of 1 g of cotoneaster per day is divided into 3 doses until 5 days. Intervention 3: Intervention group 3: The neonate with jaundice will receive cotoneaster drops and the mother will receive placebo. The mother will receive number of placebo drops per day is similar to the number of cotoneaster drops. Neonate will receive amount of 1 g of cotoneaster per day is divided into 3 doses until 5 days. Intervention 4: Intervention group 4: The neonate with jaundice will receive placebo,  and the mother will receive cotoneaster drops. The neonate will receive number of placebo drops per day is similar to the number of cotoneaster drops. Mothers will receive 5 ml of cotoneaster drops every 8 hours for 5 days.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All information will be published in an article. Details of the data are available at the request of the journal publisher and upon obtaining permission from the corresponding author.

When:
Data is available as an article as soon as the article is published with permission from the corresponding author.

To whom:
The data is provided as an article by the journal, and those who have access to the journal can use the data contained in the article, with the permission of the corresponding author.

Conditions:
The article's data is available in case of publication and is obtained by permission from the corresponding author.

Where to obtain:
The data is available to the journal and is accessible by obtaining permission from the corresponding author.

How to obtain:
Data is available from the journal after publication of the article.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Azadbakht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical Sciences, 18th Km, Khazar Abad Road, Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4817845413</zip>
        <telephone>+98 11 3354 3728</telephone>
        <email>mazadbakht110@gmail.com</email>
        <affiliation>Fharmacy Department, Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roya Farhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital, Amir Mazandarani Blv, Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4817845413</zip>
        <telephone>+98 11 3336 1700</telephone>
        <email>dr_royafarhadi@yahoo.com</email>
        <affiliation>Faculty Of Medicine, Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All term neonate who present with jaundice, whose weights are 2500 to 4000 gr and who are feeding with breast milk
The neonate 1 to 14 days old</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>14 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>blood incompatibility; Rh incompatibility; Fauvism; immaturity; need for blood transfusions; infection; hemolysis.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P59.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal jaundice, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 (Control): The neonate with jaundice and mother will receive placebo. The neonate with jaundice will receive placebo drops per day is similar to the number of cotoneaster drops. The mother will receive number of placebo drops per day is similar to the number of cotoneaster drops</i_keyword>
      <i_keyword>Intervention group 2: The neonate with jaundice and the mother both will receive cotoneaster drops. Mothers will receive 5 ml of cotoneaster drops every 8 hours for 5 days. Neonate will receive amount of 1 g of cotoneaster per day is divided into 3 doses until 5 days.</i_keyword>
      <i_keyword>Intervention group 3: The neonate with jaundice will receive cotoneaster drops and the mother will receive placebo. The mother will receive number of placebo drops per day is similar to the number of cotoneaster drops. Neonate will receive amount of 1 g of cotoneaster per day is divided into 3 doses until 5 days.</i_keyword>
      <i_keyword>Intervention group 4: The neonate with jaundice will receive placebo,  and the mother will receive cotoneaster drops. The neonate will receive number of placebo drops per day is similar to the number of cotoneaster drops. Mothers will receive 5 ml of cotoneaster drops every 8 hours for 5 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Baby serum total bilirubin. Timepoint: Every 24 hours for 5 days. Method of measurement: Laboratory test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Length of hospitalisation days. Timepoint: At the time of discharge. Method of measurement: From the time of admission to discharge.</sec_outcome>
      <sec_outcome>Added at 2017-06-11: The incidence of complications arising from the use of Cotoneaster. Timepoint: Added at 2017-06-11: Every 24 hours for 5 days. Method of measurement: Added at 2017-06-11: Observation and complete check list.</sec_outcome>
      <sec_outcome>Added at 2017-06-11: Evaluation of side effects in case of Cotoneaster. Timepoint: Added at 2017-06-11: Every 24 hours for 5 days. Method of measurement: Added at 2017-06-11: Observation and complete check list.</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, Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-04-08</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Mazandaran University of Medical Sciences, Moalem square, Sari, Mazandaran Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
