<?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>IRCT20210526051411N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-11</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Althaea rosea batching on bilirubin levels of neonates with hyperbilirubinemia</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Althaea rosea batching on bilirubin levels of neonates with hyperbilirubinemia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56703</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the present study, first, neonates with icterus whose disease is approved by a doctor and are admitted to the neonatal ward of Ali Ibn Abitaleb Hospital in Rafsanjan will be identified. Then, in order to randomly assign the infants to the phototherapy and phototherapy groups with a marshmallow bath, a coin toss (milk line) will be used. . The coin toss results are then recorded on a note sheet.
The doctor will also start the treatment based on the results, Blinding description: The present study is two-blind so that both the baby's parents and the person collecting and analyzing the information of the type of intervention and in which group the baby is placed have no information.
Newborns are admitted to different rooms.</study_design>
      <phase>N/A</phase>
      <hc_freetext>jaundice.</hc_freetext>
      <i_freetext>Intervention 1: For the intervention group, grind 5 grams of Althaea officinalis and put it in one liter of cold water for 8 hours, then take the flower extract with a strainer and then take the extract in a liter of water with a temperature of 37 to 37.5, which is continuously measured by a thermometer. we will add. The room temperature is also set between 28-24 ° C. At the beginning of admission and before the start of phototherapy, the baby is bathed with .The baby is bathed by Althaea officinalis  a trained person. The hands are thoroughly washed before the intervention. The baby's body temperature is also measured by the Beurer GmbH digital thermometer made in Germany. The baby's body is washed step by step in 5 to 7 minutes.First, the neck area, especially the area behind the baby's ears, then the chest and upper limbs, abdomen and lower limbs, and finally the baby's back will be washed. At the end, the baby's body is dried with a clean, soft towel and the baby's body temperature is checked again, and the baby is placed under phototherapy with the XHZ model (one week before the sampling of the devices are calibrated). Once an hour, according to the routine of the neonatal serum bilirubin section, it is measured by photometric method (Juandice method in the accredited laboratory of the same hospital and is continuously entered in the data collection and registration form. Intervention 2: Control group: In the control group, only phototherapy Phototherapy with XHZ device is performed routinely.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I have not decided yet - its release schedule is still unknown</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nurse Street</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>34255900</telephone>
        <email>neda.rahimi90@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nurse Street</address>
        <city>Ransanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>34255900</telephone>
        <email>nedarahimi90@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Jaundice based on the doctor's diagnosis and serum total bilirubin 13 mg / dL and above
Do not suffer from underlying diseases
Total serum bilirubin 16 mg per deciliter and above
No ABO or RH incompatibility, no G6PD enzyme disorder and no positive Coombs test
Absence of physical abnormalities in physical examination
Does not have any risk factors such as hemolysis, sepsis, asphyxia
No history of skin allergies in family members or any allergies to marshmallows
Term baby (over 38 weeks)
Weight over 2500 kg</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>10 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Increased jaundice that requires blood transfusion
Withdrawal of the baby's parents to continue participating in the research
Discharge or death of the infant before the end of the intervention period
The baby becomes ill during the course of the disease and during the study, which for any reason contradicts the intervention.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified jaundice</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For the intervention group, grind 5 grams of Althaea officinalis and put it in one liter of cold water for 8 hours, then take the flower extract with a strainer and then take the extract in a liter of water with a temperature of 37 to 37.5, which is continuously measured by a thermometer. we will add. The room temperature is also set between 28-24 ° C. At the beginning of admission and before the start of phototherapy, the baby is bathed with .The baby is bathed by Althaea officinalis  a trained person. The hands are thoroughly washed before the intervention. The baby's body temperature is also measured by the Beurer GmbH digital thermometer made in Germany. The baby's body is washed step by step in 5 to 7 minutes.First, the neck area, especially the area behind the baby's ears, then the chest and upper limbs, abdomen and lower limbs, and finally the baby's back will be washed. At the end, the baby's body is dried with a clean, soft towel and the baby's body temperature is checked again, and the baby is placed under phototherapy with the XHZ model (one week before the sampling of the devices are calibrated). Once an hour, according to the routine of the neonatal serum bilirubin section, it is measured by photometric method (Juandice method in the accredited laboratory of the same hospital and is continuously entered in the data collection and registration form.</i_keyword>
      <i_keyword>Control group: In the control group, only phototherapy Phototherapy with XHZ device is performed routinely</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bilirubin level. Timepoint: Before and after the study. Method of measurement: Photometry (by Juandice method.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-28</approval_date>
        <contact_name>Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Nurse Street Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
