<?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>IRCT20180404039187N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-06</date_registration>
      <primary_sponsor>Research Vice-chancellor</primary_sponsor>
      <public_title>The efficacy of piracetam on children with global developmental delay</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of piracetam on children with global developmental delay</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78121</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>global developmental delay.</hc_freetext>
      <i_freetext>In this study, 40 patients with developmental delay in more than or equal to 2 developmental areas are selected from among the patients referred to the pediatric neurology clinics and the Comprehensive Child Development Center. For these patients, after obtaining informed consent, the Iranian brand Piracetam syrup with the same name, Piracetam, is prescribed at a dose of 40 mg/kg/day once daily. Piracetam belongs to the racetam group, with the chemical name 2-oxo-1-pyrrolidine acetamide. This drug is a cyclic derivative of the neurotransmitter GABA and has the same 2-oxo-pyrrolidone basic structure as pyroglutamic acid. Piracetam is a positive allosteric modulator of the AMPA receptor, acting on ion channels or ion carriers, resulting in increased neuronal excitability. Piracetam affects NMDA glutamate receptors, which are involved in learning and memory processes, through muscarinic cholinergic receptors (ACh), which are involved in memory processes. This drug has been shown to increase oxygen consumption in the brain. The mother is given an age-appropriate ASQ form and is advised to practice, repeat, and teach the age-appropriate activities on the form with her child. Three months later, and six months after starting piracetam, the ASQ forms are completed by the same individual, and their results are compared with those on the previous forms. An improvement in the ASQ score of more than one standard deviation (SD) is considered a response to treatment..</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Bita Poorshiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zahra Mardani Azari Children's Education, Research and Treatment Center, Mardani Azari Street, Khavaran, Tabriz, Iran</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5169780026</zip>
        <telephone>009841331595050</telephone>
        <email>bpskam@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Bita Poorshiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zahra Mardani Azari Children's Education, Research and Treatment Center, Mardani Azari Street, Khavaran, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5169780026</zip>
        <telephone>+98 41 3159 5050</telephone>
        <email>bpskam@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age below 5 years and above 2 months
Developmental delay in more than or equal to two developmental domains</inclusion_criteria>
      <agemin>2 months</agemin>
      <agemax>5 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a metabolic disease or underlying structural disorder
Lack of informed consent to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F83</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Specific developmental disorder of motor function</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, 40 patients with developmental delay in more than or equal to 2 developmental areas are selected from among the patients referred to the pediatric neurology clinics and the Comprehensive Child Development Center. For these patients, after obtaining informed consent, the Iranian brand Piracetam syrup with the same name, Piracetam, is prescribed at a dose of 40 mg/kg/day once daily. Piracetam belongs to the racetam group, with the chemical name 2-oxo-1-pyrrolidine acetamide. This drug is a cyclic derivative of the neurotransmitter GABA and has the same 2-oxo-pyrrolidone basic structure as pyroglutamic acid. Piracetam is a positive allosteric modulator of the AMPA receptor, acting on ion channels or ion carriers, resulting in increased neuronal excitability. Piracetam affects NMDA glutamate receptors, which are involved in learning and memory processes, through muscarinic cholinergic receptors (ACh), which are involved in memory processes. This drug has been shown to increase oxygen consumption in the brain. The mother is given an age-appropriate ASQ form and is advised to practice, repeat, and teach the age-appropriate activities on the form with her child. Three months later, and six months after starting piracetam, the ASQ forms are completed by the same individual, and their results are compared with those on the previous forms. An improvement in the ASQ score of more than one standard deviation (SD) is considered a response to treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1) Improvement of performance in the area of ​​fine movements 2) Improvement of performance in the area of ​​gross movements 3) Improvement of performance in the area of ​​communication 4) Improvement of performance in the area of ​​problem-solving 5) Improvement of performance in the personal-social area. Timepoint: Evaluation of the developmental form of the ASQ at the beginning of the study, 3 months, and 6 months after the start of the drug. Method of measurement: The effect of Piracetam on improving the development of a person, which is evaluated by the ASQ developmental questionnaire.</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>Research Vice-chancellor</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-10</approval_date>
        <contact_name>Iran National Committee for Ethics in Biomedical Research</contact_name>
        <contact_address>Khavaran Twon, Zahra Mardani Azari Child Hospital, Tabriz, East Azarbaijan tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
