<?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>IRCT20200813048398N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-22</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of feeding on the duration of patient separation from mechanical ventilation</public_title>
      <acronym></acronym>
      <scientific_title>The effect of planned feeding on the duration of patient separation from mechanical ventilation and stay in the intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50332</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of planned feeding on the duration of patient isolation from mechanical ventilation and the length of stay in the intensive care unit.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group to supply energy the standard EnteraMeal solution will be used which has one kilocalorie of energy per milliliter and the distribution of macronutrients as 14% energy from protein, 33% energy from fat and 54% energy from carbohydrates. To prepare 150 ml, 33 g (one measure) of EnteraMeal powder is poured into 120 ml of cooled boiled water and this solution has one kilocalorie per ml of energy. Feeding is performed by Intragastric nasogastric tube by bolus infusion method with a 60 cc syringe which to reach the calculated energy in 48-72 hours Start with 50 cc and add 30 cc every three hours. The schedule of prescribing hours is as follows: 6, 9, 12, 15, 18 and 21. Intervention 2: Control group: In the control group, hospital gavage fluid will be used without interfering in it’s preparation method Which is sent to the Laboratory of Nutrition Department of Paramedical School for analysis of macronutrients and energy.</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 There is no need to mention them in the trial.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sakineh Javdan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences and Health Services, Golestan Ave, Ahvaz, Khuzestan Province</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794 - 61357</zip>
        <telephone>+98 61 3332 3685</telephone>
        <email>javdansakineh@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Asadizaker</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>, Ahvaz Jundishapur University of Medical Sciences and Health Services, Golestan Ave, Ahvaz, Khuzestan Province</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794 - 61357</zip>
        <telephone>+98 61 3332 3685</telephone>
        <email>marziyehasadizaker@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Hospitalized in the intensive care unit up to 24 hours after admission to the hospital
Age 18 to 65 years
Feeding through nasopharyngeal catheter
Patients under mechanical ventilation for more than 24 hours
No pregnancy
Lack of obesity (patients with a body mass index above 40)
Patient with Liver disease or severe infection
Patient with kidney disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Change the type of feeding from gavage to complete intravenous feeding
Transfer or discharge the patient from the ICU</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R63.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Feeding difficulties</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group to supply energy the standard EnteraMeal solution will be used which has one kilocalorie of energy per milliliter and the distribution of macronutrients as 14% energy from protein, 33% energy from fat and 54% energy from carbohydrates. To prepare 150 ml, 33 g (one measure) of EnteraMeal powder is poured into 120 ml of cooled boiled water and this solution has one kilocalorie per ml of energy. Feeding is performed by Intragastric nasogastric tube by bolus infusion method with a 60 cc syringe which to reach the calculated energy in 48-72 hours Start with 50 cc and add 30 cc every three hours. The schedule of prescribing hours is as follows: 6, 9, 12, 15, 18 and 21.</i_keyword>
      <i_keyword>Control group: In the control group, hospital gavage fluid will be used without interfering in it’s preparation method Which is sent to the Laboratory of Nutrition Department of Paramedical School for analysis of macronutrients and energy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum pre-albumin level in the intervention and control groups. Timepoint: Before and after the intervention. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>Duration of patient connection to ventilator in two groups of intervention and control. Timepoint: Before and after the intervention. Method of measurement: chronometer.</prim_outcome>
      <prim_outcome>The length of stay in intensive care unit between intervention and control groups. Timepoint: Before and after the intervention. Method of measurement: Number of days the patient is hospitalized.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum prealbumin levels in both intervention and control groups. Timepoint: Before and after the intervention. Method of measurement: Laboratory.</sec_outcome>
      <sec_outcome>Duration of patient connection to ventilator in two groups of intervention and control. Timepoint: Before and after the intervention. Method of measurement: chronometer.</sec_outcome>
      <sec_outcome>The length of stay in intensive care unit between intervention and control groups. Timepoint: Before and after the intervention. Method of measurement: Number of days the patient is hospitalized.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-15</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology Development,  next to the central organization of Ahvaz Jundishapur University of Medical Sciences and Health Services, university city, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
