<?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>IRCT20190128042528N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-18</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Enteral Feeding on Paraclinical Outcome</public_title>
      <acronym></acronym>
      <scientific_title>Comparision of The Effect of Enteral Feeding ThroughThe Bolus &amp; Continuous Methods on Paraclinical Outcome &amp; Incidence of Diarrhea in Patient With Mechanical Ventilation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37161</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Study participants are randomly assigned to study groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Paraclinical changes in continuous feeding and bolus feeding.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Patients in this group received continuous enteral feeding with standard commercial solution of enterameal of karen group. After adding 11.3 g of powder to 50 cc of water, each cc contains one kcal of energy. In this method, the patient started feeding at 25cc / h in a semi-seated position. And every three hours the volume of gastric residue was measured, and if the volume of gastric residue was less than 50% of the volume of the patient's previous three hours, the patient's gavage was continued and the patient's gavage volume was increased in calories, if any. When the volume of the stomach was more than 50% of the volume of gavage in the last three hours, the patient's gavage was cut for three hours. On the first day of the patient's gavage, 50% of the patient's nutritional intake was met, and within 48 hours we reached the final nutritional goal of 25kcal / kg / day, and continued with the same target volume until the end of the study . Intervention 2: Control group: Patients in this group received enteral feeding through routine (bolus) and with standard commercial enterameal solution. After adding 11.3 g of powder to 50 cc of water, each cc contains one kcal of energy. In this method, the patient  started feeding at a rate of 75cc / 3h in a semi-sitting position And every three hours the volume of gastric residue was measured, and if the volume of gastric residue was less than 50% of the volume of the patient's previous three hours, the patient's gavage was continued and the patient's gavage volume was increased in calories, if any. When the volume of the stomach was more than 50% of the volume of gavage in the last three hours, the patient's gavage was cut for three hours. On the first day of the patient's gavage, 50% of the patient's nutritional intake was met, and within 48 hours we reached the final nutritional goal of 25kcal / kg / day, and continued with the same target volume until the end of the study .</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:
Only original data is shared

When:
1 year after publishing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Comparison with data from similar studies

Where to obtain:
jseyedi30@yahoo.com

How to obtain:
--

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Javad Seyyedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Langhroodi Al., Imam Khomeini Ave.,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1319847858</zip>
        <telephone>+98 21 6638 7619</telephone>
        <email>jseyedi30@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Javad Seyyedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Langhroodi Al., Imam Khomeini Ave.,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1319847858</zip>
        <telephone>+98 21 6638 7619</telephone>
        <email>jseyedi30@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient with mechanical ventilation throught the endotracheal tube
Feeding of  Patient with NG tube
Patient attendant satisfaction
18-85 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient with digestive Disease( diarrhea, ileus, obstruction, ostomy)
Patient with renal failure</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Patients in this group received continuous enteral feeding with standard commercial solution of enterameal of karen group. After adding 11.3 g of powder to 50 cc of water, each cc contains one kcal of energy. In this method, the patient started feeding at 25cc / h in a semi-seated position. And every three hours the volume of gastric residue was measured, and if the volume of gastric residue was less than 50% of the volume of the patient's previous three hours, the patient's gavage was continued and the patient's gavage volume was increased in calories, if any. When the volume of the stomach was more than 50% of the volume of gavage in the last three hours, the patient's gavage was cut for three hours. On the first day of the patient's gavage, 50% of the patient's nutritional intake was met, and within 48 hours we reached the final nutritional goal of 25kcal / kg / day, and continued with the same target volume until the end of the study ...</i_keyword>
      <i_keyword>Control group: Patients in this group received enteral feeding through routine (bolus) and with standard commercial enterameal solution. After adding 11.3 g of powder to 50 cc of water, each cc contains one kcal of energy. In this method, the patient  started feeding at a rate of 75cc / 3h in a semi-sitting position And every three hours the volume of gastric residue was measured, and if the volume of gastric residue was less than 50% of the volume of the patient's previous three hours, the patient's gavage was continued and the patient's gavage volume was increased in calories, if any. When the volume of the stomach was more than 50% of the volume of gavage in the last three hours, the patient's gavage was cut for three hours. On the first day of the patient's gavage, 50% of the patient's nutritional intake was met, and within 48 hours we reached the final nutritional goal of 25kcal / kg / day, and continued with the same target volume until the end of the study ...</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum albumin level. Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: Analysis by Bromocresol Green Pars Test Laboratory Kit.</prim_outcome>
      <prim_outcome>Serum level of pre-albumin. Timepoint: Before the intervention and 2 days after the intervention. Method of measurement: Analysis by Nephlometry Laboratory Kit Brand Binding site.</prim_outcome>
      <prim_outcome>Serum phosphate level. Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: Photometric analysis uv test.</prim_outcome>
      <prim_outcome>Serum lactate level. Timepoint: Before the intervention and 7 days after the intervention. Method of measurement: Enzymatic / colorimetric analysis kit by Fars Bayer Lab.</prim_outcome>
      <prim_outcome>Frequency of defecation. Timepoint: During 7 days of intervention. Method of measurement: View and record in data log sheet.</prim_outcome>
      <prim_outcome>Patient's blood sugar. Timepoint: Every six hours. Method of measurement: clever check Glucometer.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-02</approval_date>
        <contact_name>Ethics committee of Tehran university of medical scinces</contact_name>
        <contact_address>No.1,Langroudi Ave.,Imam Khomeyni Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
