<?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>IRCT2013120815458N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-03</date_registration>
      <primary_sponsor>Hormozgan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of sucking in preterm infants without give milk that admitted to hospital</public_title>
      <acronym></acronym>
      <scientific_title>Effects of non-nutritive sucking and feeding  in preterm infants growth,that admitted to Children's Hospital and Shariati  in Bandar Abbas in 2012.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>69</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14724</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Development of feeding in preterm infants.</hc_freetext>
      <i_freetext>Intervention 1: In interventional group: neonates stimulate every day, 2 times for 15 minutes  for 10 days and  the breastfeeding will be done free from milk or a pacifier. Until the start of oral feeding in preterm infants.Oral intake begin when neonates   stable clinically and hemodynamically.Depending on the Physical conditions , oral feeding newborn will be done 20 ml per kilogram per day. Weight and head circumference will be measured at baseline. Then weekly head circumference and weight will be measured daily. Also at the time of discharge, head circumference, and weight will be recorded. Weight recorded by one person and used directly in the  micro-balance RASA will be done. Weight and head circumference will be analyzed. Intervention 2: In  control group :neonates will not stimulate  with the breastfeeding or pacifier .Oral intake begin when neonates stable clinically and hemodynamicallyDepending on the Physical conditions , oral feeding newborn will be done 20 ml per kilogram per day. Weight and head circumference will be measured at baseline. Then weekly head circumference and weight will be measured daily. Also at the time of discharge, head circumference, and weight will be recorded. Weight recorded by one person and used directly in the  micro-balance RASA will be done. Weight and head circumference will be analyzed.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Rakhshaneh goodarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children's Hospital of Bandar Abbas,Golshahr</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+7 616676291</telephone>
        <email>Rgoodarzi@oldhums.ac.ir</email>
        <affiliation>Hormozgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Rakhshaneh goodarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children's Hospital of Bandar Abbas,Golshahr</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 76 1667 6291</telephone>
        <email>Rgoodarzi@oldhums.ac.ir</email>
        <affiliation>Hormozgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria:  Informed consent of the mother, age between 32-26 weeks and birth weight less than 1500 g.&#13;
Exclusion Criteria: Neonates with severe asphyxia, malformations, cranial hemorrhage grade 3 or 4 infections at the onset or during the study and very ill newborns</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>1 year</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P05-P08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders related to length of gestation and fetal growth</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In interventional group: neonates stimulate every day, 2 times for 15 minutes  for 10 days and  the breastfeeding will be done free from milk or a pacifier. Until the start of oral feeding in preterm infants.Oral intake begin when neonates   stable clinically and hemodynamically.Depending on the Physical conditions , oral feeding newborn will be done 20 ml per kilogram per day. Weight and head circumference will be measured at baseline. Then weekly head circumference and weight will be measured daily. Also at the time of discharge, head circumference, and weight will be recorded. Weight recorded by one person and used directly in the  micro-balance RASA will be done. Weight and head circumference will be analyzed.</i_keyword>
      <i_keyword>In  control group :neonates will not stimulate  with the breastfeeding or pacifier .Oral intake begin when neonates stable clinically and hemodynamicallyDepending on the Physical conditions , oral feeding newborn will be done 20 ml per kilogram per day. Weight and head circumference will be measured at baseline. Then weekly head circumference and weight will be measured daily. Also at the time of discharge, head circumference, and weight will be recorded. Weight recorded by one person and used directly in the  micro-balance RASA will be done. Weight and head circumference will be analyzed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amount of weight infants. Timepoint: Daily after feeding the infant. Method of measurement: Rasa microbalance.</prim_outcome>
      <prim_outcome>Head circumference. Timepoint: Weekly. Method of measurement: Centimeter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: Admission until discharge. Method of measurement: daily.</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>Hormozgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-08-12</approval_date>
        <contact_name>Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Shahid Chamran Blvd., beside the Governor Bandarabbas  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
