<?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>IRCT20141118019991N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-16</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of increasing the amount of milk protein content by protein supplement on growth indices of preterm infants</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of increasing the amount of milk protein content by protein supplement on growth indices of preterm infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17742</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: We will Use permuted block randomization and assign participants 1:1 to the standard of care diet (control) or higher protein Diet (intervention).
Twins will be randomized individually. The study biostatistician will generate the allocation sequence and place the research assignments in envelopes, to be opened by research assistants on the study start date, Blinding description: Parents, clinical staff, and all study staff apart from the research assistants who prepare the study diet will be blinded to the study group. Unblinding will be permitted if an error in milk preparation is identified, or if unexpected safety concerns arise that require unblinding.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Very Low Birth Weight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: High protein diet (4 grams per kilogram per day)  which is provided by protein supplement, when the enteral feeding has been started. Intervention 2: Control group: Routine protein diet (3.5 grams per kilogram per day)  which is provided by protein supplement, when the enteral feeding has been started.</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>Vali-asr hospital, Imam Khomeini Hospital Complex, Tohid Squre</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 2274 9212</telephone>
        <email>s_talebiyan@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saharnaz Talebiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali-asr hospital, Imam Khomeini Hospital Complex, Tohid Squre</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 2274 9212</telephone>
        <email>s_talebiyan@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gestational age less than 34 weeks
Birth weight less than 1500 grams
No  anomalies which affect on growth</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>30 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parents disapproval
Unable to continue feeding more than 72 hours
Urea over than 50 milligram per deciliter</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Extremely low birth weight newborn, unspecified weight</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: High protein diet (4 grams per kilogram per day)  which is provided by protein supplement, when the enteral feeding has been started.</i_keyword>
      <i_keyword>Control group: Routine protein diet (3.5 grams per kilogram per day)  which is provided by protein supplement, when the enteral feeding has been started.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: Daily from the first day of life. Method of measurement: Digital scale.</prim_outcome>
      <prim_outcome>Height. Timepoint: Weekly from the first day of life. Method of measurement: meter.</prim_outcome>
      <prim_outcome>Head Circumference. Timepoint: Weekly from the first day of life. Method of measurement: meter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Urea. Timepoint: Biweekly. Method of measurement: Blood Sample Enzymatic tests (gr/dl).</sec_outcome>
      <sec_outcome>‌Bicarbonate. Timepoint: Biweekly. Method of measurement: Blood Sample enzymatic auto-analyzer.</sec_outcome>
      <sec_outcome>Calcium. Timepoint: Biweekly. Method of measurement: Blood Sample Enzymatic tests (mg/dl).</sec_outcome>
      <sec_outcome>Phosphorus. Timepoint: Biweekly. Method of measurement: Blood Sample Enzymatic tests (mg/dl).</sec_outcome>
      <sec_outcome>Alkaline phosphatase. Timepoint: Biweekly. Method of measurement: Blood Sample Enzymatic tests.</sec_outcome>
      <sec_outcome>Albumin. Timepoint: Biweekly. Method of measurement: Blood Sample Enzymatic tests.</sec_outcome>
      <sec_outcome>Total protein. Timepoint: Biweekly. Method of measurement: Blood Sample Enzymatic tests (gr/dl).</sec_outcome>
      <sec_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.</sec_outcome>
      <sec_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.</sec_outcome>
      <sec_outcome>Hospitalization Duration. Timepoint: Hospitalization Duration by days number at discharge. Method of measurement: Hospitalization Duration days.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-01-30</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
