<?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>IRCT20190410043224N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-20</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>"Effect of Gabapentin in treatment of feeding refusal disorder"</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Gabapentin with placebo in feeding improvement in feeding refusal infants age 3 to 6 months</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54082</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into 2 equal case and control groups on sex by permutation blocks randomization in volume 4, using the R softwsre, Blinding description: Individuals assigning infants to groups, as well as mothers will be unaware of the allocation process and sequence.</study_design>
      <phase>3</phase>
      <hc_freetext>lnfants feeding refusal disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Intervention group: The intervention group includes 32 infants aged 3 to 6 months who have feeding refusal  and have no reflux or other acute or chronic disease.  How to choose them is random and with the help of software and mothers and prescribing doctors do not know whether the drug or placebo is given to the infants.They are given gabapentin syrup, which contains 60 mg of the drug per cc, and is made by a pharmacologist, a faculty member of Isfahan University of Medical Sciences, who is a partner in the project, at a dose of 5 mg per kilogram of body weight every 8 hours.  And if infant do not get too sleepy at the end of the first week the dose is rised to 10 mg per kilogram of body weight.  The amount of milk consumed is recorded before the start of the drug and at the end of the second week and the first month. Intervention 2: Control group: Control group: In the control group, the same number of intervention groups of patients are randomly selected with the help of software and they are given a placebo with the same dose of the main drug.  And monitoring them is like an intervention group.  Mothers and prescribing physicians are not aware that the drug or placebo is given to the child. Medication is one of the basic ingredients of the main medicine and does not contain only gabapentin.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam khomeini Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8195163381</zip>
        <telephone>+98 31 3386 6266</telephone>
        <email>heydari.pedres@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam khomeini Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8195163381</zip>
        <telephone>+98 31 3386 6266</telephone>
        <email>heydari.pedres@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 3 to 6 months
The score of reflux questionary 16 or lower
Lack of an acute or chronic disease</inclusion_criteria>
      <agemin>3 months</agemin>
      <agemax>6 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The score of the reflux questionary greater than 16
Presence of an acute or chronic disease
Starting of complementary foods</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Intervention group: The intervention group includes 32 infants aged 3 to 6 months who have feeding refusal  and have no reflux or other acute or chronic disease.  How to choose them is random and with the help of software and mothers and prescribing doctors do not know whether the drug or placebo is given to the infants.They are given gabapentin syrup, which contains 60 mg of the drug per cc, and is made by a pharmacologist, a faculty member of Isfahan University of Medical Sciences, who is a partner in the project, at a dose of 5 mg per kilogram of body weight every 8 hours.  And if infant do not get too sleepy at the end of the first week the dose is rised to 10 mg per kilogram of body weight.  The amount of milk consumed is recorded before the start of the drug and at the end of the second week and the first month.</i_keyword>
      <i_keyword>Control group: Control group: In the control group, the same number of intervention groups of patients are randomly selected with the help of software and they are given a placebo with the same dose of the main drug.  And monitoring them is like an intervention group.  Mothers and prescribing physicians are not aware that the drug or placebo is given to the child. Medication is one of the basic ingredients of the main medicine and does not contain only gabapentin.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of effective breastfeeding. Timepoint: At the beginning of the study and at the end of the second week and the first month. Method of measurement: The number of feedings from the mother's breast that lasts at least 10 minutes or the mother feels empty breasts and the volume of formula to cc.</prim_outcome>
      <prim_outcome>Volume of formula consumed. Timepoint: Before the intervention, the end of the second week and the end of the first month. Method of measurement: Frequency of breastfeeding that lasts at least 10 minutes or the mother feels empty breasts-volume of formula consumed in mililiter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Restlessness. Timepoint: The end of the first months. Method of measurement: Asking from mother.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-04</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Imam khomeini Ave Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
