<?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>IRCT20141118019991N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-16</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effect of oropharyngeal colostrum in very low birth weight premature  infant.</public_title>
      <acronym>LBW</acronym>
      <scientific_title>Evaluating the effect of oropharyngeal colostrum administration from the first day of life in  very low birth weight premature infant</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35216</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Utilizing "RAS", permuted randomization was conducted on the sample population. Permuted Block Randomization of the Individual type was performed. The allocation concealment was done by The Data Safety and Monitoring Center of  Shohadaye Tajrish Hospital's Clinical Research Development Department, Blinding description: This study was a double-blinded study in which the patients, the nurses, the conductors, and the analyst _who later joined the research team and was not a member initially _ were not aware of the sampling procedures and the method by which randomly chosen treatments were administered to the patients.The method was carried out and authorized by "The Safety and Monitoring Committee.".</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Sepsis. Condition 2: Narcotizing Enterocolitis. Condition 3: Mortality. Condition 4: Hospitalization Duration. Condition 5: Full Fed time.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Oropharyngeal administration of 0.2 cc Colostrum was started at the first hour of life, It was given every 3 hour for 3 days. Intervention 2: Control group: Breast Milk Minimal Enteral Feeding administration was started after 72 hours of life.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saharnaz Talebiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohada Hospital, Tajrish Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21 2271 3333</telephone>
        <email>s_talebiyan@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saharnaz Talebiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohada Hospital, Tajrish Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21 2271 3333</telephone>
        <email>s_talebiyan@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Birth Weight lower than 1500 grams
Gestational Age lower than 32 weeks
Infant without congenital abnormalities.
No evidence of asphyxia.</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>1 day</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Birth Weight more than 1500 grams.
Gestational Age more than 32 weeks.
Infant with congenital abnormalities.
Infant with asphyxia.
Need for resuscitation after birth.
Drug Abuser mother.
Mother who has HIV positive test.
Mothers who are Cytomegal Virus seropositive</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A41.9</hc_code>
      <hc_code>P77.9</hc_code>
      <hc_code>R99</hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sepsis, unspecified organism</hc_keyword>
      <hc_keyword>Necrotizing enterocolitis in newborn, unspecified</hc_keyword>
      <hc_keyword>Ill-defined and unknown cause of mortality</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Oropharyngeal administration of 0.2 cc Colostrum was started at the first hour of life, It was given every 3 hour for 3 days.</i_keyword>
      <i_keyword>Control group: Breast Milk Minimal Enteral Feeding administration was started after 72 hours of life.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sepsis Early or Late Onset, clinical or Para-clinical Sign and Symptoms. Timepoint: Multiple clinical Evaluation per day, and if needed also Para-clinical evaluation. Method of measurement: Clinical and Para-clinical Signs and Symptoms.</prim_outcome>
      <prim_outcome>Clinical and Para-clinical sign of Necrotizing  Enterocolitis. Timepoint: Multiple clinical Evaluation per day, and if needed also Para-clinical evaluation. Method of measurement: Clinical and Para-clinical Signs and symptoms.</prim_outcome>
      <prim_outcome>Hospitalization Duration. Timepoint: Hospitalization Duration by days number at discharge. Method of measurement: Hospitalization Duration.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mortality. Timepoint: the time of Dead. Method of measurement: Vital sign not recorded and no respond to Resuscitation.</sec_outcome>
      <sec_outcome>Weight gain progress. Timepoint: Daily. Method of measurement: SEGA digital scale.</sec_outcome>
      <sec_outcome>The time to reach full enteral feeding (120 cc / kg). Timepoint: Daily. Method of measurement: It was calculated every day by the neonatologist and Neonate feeding tolerance .</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-06</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shohada Hospital, Tajrish Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
