<?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>IRCT20210607051507N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-25</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of colostrum on the short outcome of premature infants</public_title>
      <acronym></acronym>
      <scientific_title>To assess the efficacy of oropharyngeal colostrum therapy on short outcome among preterm neonates</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58860</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Our sample size is 126, which is done by the cards or envelopes shuffling method. In this method, a number of cards selected by the researcher as group A and the same number of cards for group B are considered. This card will be returned to the other cards after leaving, Blinding description: The list of random allocation of patients will be available only to the epidemiologist of the project. To hide the random allocation process, the order of interventions will be written on 126 cards and each card will be placed in an envelope (with a suitable thickness that it is not possible to read the type of intervention on the cover of the envelope). When the interviewer declares a baby eligible, the methodologist will provide the group with an intervention plan. The person evaluating the intended outcomes is a third party who is unaware of the random allocation process and the type of treatment performed. For data analysis, a statistician who is separate from the study process and is unaware of all the processes performed will be used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of colostrum on the short-term prognosis of preterm infants.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 63 infants received 0.2 cc of their mother's colostrum via the oropharynx every 6 hours to 3 days from birth to the first 72 hours of birth. Intervention 2: Control group: The other 63 infants were placebo and received 0.2 cc of distilled water.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ameneh Lamsehchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan Province, Hamedan, District 1, Pasdaran Ave,</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۷۸۹۹۷۱</zip>
        <telephone>+98 81 3827 7459</telephone>
        <email>lamsehchila@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>behnaz basiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan Province, Hamedan, District 1, Pasdaran Ave</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۷۸۹۹۷۱</zip>
        <telephone>+98 81 3827 7459</telephone>
        <email>vc_research@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Premature infants under 32 weeks of gestation Or below 1500 grams</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Genetic and chromosomal abnormalities,
HIV-positive mother,
drug-addicted mother
Any case where there is a limitation on milk usage for the baby</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preterm [premature] newborn [other]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 63 infants received 0.2 cc of their mother's colostrum via the oropharynx every 6 hours to 3 days from birth to the first 72 hours of birth.</i_keyword>
      <i_keyword>Control group: The other 63 infants were placebo and received 0.2 cc of distilled water.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of preterm neonatal hospitalization. Timepoint: From the time of birth and hospitalization to the time of discharge. Method of measurement: Extract from the file.</prim_outcome>
      <prim_outcome>How long it takes for a baby to be fully breastfed. Timepoint: From the onset of colostrum to breastfeeding 150 cc per kilogram of body weight. Method of measurement: Extract from the file.</prim_outcome>
      <prim_outcome>Necrotizing enterocolitis in preterm infants. Timepoint: Since diagnosis based on clinical and radiological and laboratory symptoms. Method of measurement: Extraction from the file and clinical signs and radiological evidence recorded in the file.</prim_outcome>
      <prim_outcome>Death of neonate. Timepoint: If there is no response to resuscitation and cardio-respiratory arrest. Method of measurement: Extract from file.</prim_outcome>
      <prim_outcome>Confirmed neonatal sepsis. Timepoint: Since the diagnosis of neonates with clinical signs of sepsis with positive culture. Method of measurement: Extract blood and crp culture tests from hospital records and electronic systems.</prim_outcome>
      <prim_outcome>Clinical neonatal sepsis. Timepoint: Infant with clinical signs of sepsis diagnosed by a pediatrician. Method of measurement: Extract from file.</prim_outcome>
      <prim_outcome>Brain hemorrhage. Timepoint: Brain sonography. Method of measurement: extract from file.</prim_outcome>
      <prim_outcome>Bronchopulmonary dysplasia. Timepoint: Since the doctor's diagnosis and oxygen dependence. Method of measurement: Extract from file.</prim_outcome>
      <prim_outcome>ROPs requiring laser surgery. Timepoint: Since the diagnosis of the eye to the doctor based on the need for laser surgery until 1 month old. Method of measurement: Extract from file.</prim_outcome>
      <prim_outcome>Ventilator-associated pneumonia. Timepoint: Based on physician's diagnosis and radiographic findings. Method of measurement: Extract from file.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-04</approval_date>
        <contact_name>Ethics Committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Mahdieh St. Research Square Shahid Fahmideh St. University of Medical Sciences and Health Services Vice Chancellor for Research and Technology Hamedan Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
