<?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>IRCT20160511027853N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-31</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>"Evaluation of the effect of Erythropoietin on Antropometric results";"Evaluation of the effect of Erythropoietin on Edema"</public_title>
      <acronym></acronym>
      <scientific_title>Anthropometric Outcome and Edema in Low Birth Weight Infants Treated With Erythropoietin</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47069</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, with a sample size of 80 neonates, 40 balls for the intervention group, and 40 balls for the control group are placed in a lottery container, and then the balls are randomly removed from the container without replacement and the created sequence is recorded.</study_design>
      <phase>4</phase>
      <hc_freetext>prematurity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Anthropometric characteristics of infants include birth weight, height, and head circumference. The RETIC and CBCdiff are tested one week after birth. Two weeks after birth, Erythropoietin is given three times a week for a month (12 times). The 2000 u Erythropoietin ampule produced by Sinagen Pharmaceutical Company is used, 100 units per kilogram for each baby. The tests are re-checked two weeks after the last Erythropoietin injection. In the control group, without drug injection, the tests are performed at 14 and 40 days of age. After the injection, the injection side-effects and edema are examined. Finally, the anthropometric tests and criteria are compared before and after the intervention. If Erythropoietin is effective, the primary consequences are increased in neonatal improvements, such as sucking and swallowing power, secondary outcomes, including; improved neonatal general condition, prevention of neonatal apnea, improved neonatal anthropometric criteria, and reduced edema. Intervention 2: Control group: These babies are prone to infection and malaise due to their pre-term. At the discretion of the Clinical Ethics Committee, no placebo is used for this group and they receive routine treatment.</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 potential data can be shared after people have not been identified

When:
Start accessing data immediately after the article is published

To whom:
It will only be available to researchers working in academic and scientific institutions

Conditions:
There are no other conditions

Where to obtain:
Refer to Dr. Seyed Hoshyar Mojabi

How to obtain:
Giving an email to Dr. Seyed Hoshyar Mojabi and answering within a week at most

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farahnaz Mohammadkhaniha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar Educational and Medical Center،Taleghani Ave،Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3415613176</zip>
        <telephone>+98 28 3323 6380</telephone>
        <email>farahnaz.mohammadkhaniha@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Seyed Hoshyar Mojabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar Educational and Medical Center, Taleghani Ave,Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3415613176</zip>
        <telephone>+98 28 3323 6380</telephone>
        <email>mogabi1355@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Premature birth with gestational age at birth less than 35 weeks
Birth weight less than 2000 grams
No illness (healthy babies who experience no problems or sickness in the first week of birth).</inclusion_criteria>
      <agemin>7 days</agemin>
      <agemax>40 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Congenital anomalies
depression
thrombocytopenia
diastolic pressure greater than 60 mmHg
shock
hydrops fetalis
threesomes
seizures
hemolytic diseases.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Anthropometric characteristics of infants include birth weight, height, and head circumference. The RETIC and CBCdiff are tested one week after birth. Two weeks after birth, Erythropoietin is given three times a week for a month (12 times). The 2000 u Erythropoietin ampule produced by Sinagen Pharmaceutical Company is used, 100 units per kilogram for each baby. The tests are re-checked two weeks after the last Erythropoietin injection. In the control group, without drug injection, the tests are performed at 14 and 40 days of age. After the injection, the injection side-effects and edema are examined. Finally, the anthropometric tests and criteria are compared before and after the intervention. If Erythropoietin is effective, the primary consequences are increased in neonatal improvements, such as sucking and swallowing power, secondary outcomes, including; improved neonatal general condition, prevention of neonatal apnea, improved neonatal anthropometric criteria, and reduced edema.</i_keyword>
      <i_keyword>Control group: These babies are prone to infection and malaise due to their pre-term. At the discretion of the Clinical Ethics Committee, no placebo is used for this group and they receive routine treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Around the head. Timepoint: Birth, one week after birth, two weeks after birth, forty days after birth. Method of measurement: Tape Measure.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Birth, one week after birth, two weeks after birth, forty days after birth. Method of measurement: Baby digital scale with SCEA brand, Model 374, which weighs 5 grams.</prim_outcome>
      <prim_outcome>Edema. Timepoint: daily. Method of measurement: Pitting Edema Grading Scale.</prim_outcome>
      <prim_outcome>Height. Timepoint: Birth day and forty day of birth. Method of measurement: Tape Measure.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The general condition of the neonate. Timepoint: every hour. Method of measurement: General examination of infants in terms of tachypnea, cyanosis, lactation, excretion, weight gain.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-14</approval_date>
        <contact_name>Ethics committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Kosar Hospital, Taleqani Ave,Qazvin,Iran Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
