<?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>IRCT2015122325673N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-26</date_registration>
      <primary_sponsor>Dezful University of Medical Sciences</primary_sponsor>
      <public_title>Comparison between two non-nutritive-sucking methods on the time needed to achieve full oral feeding in preterm infants</public_title>
      <acronym></acronym>
      <scientific_title>The comparison between the effect of two non-nutritive-sucking methods include emptied breast and pacifier sucking on the time needed to achieve full oral feeding in preterm infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21425</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preterm neonate's nutritinal status.</hc_freetext>
      <i_freetext>Intervention 1: In the first intervention group, non-nutritional sucking stimulation will be performed using a pacifier twice a day in the morning and in the evening while doctor start to feed infant. The intervention will be performed for 10 consecutive days by trained expert. Oral stimulation program contains two forms of oral stimulation. Around and in mouth stimulation will be done by hand for three minutes and it will be continued sucking by use of a pacifier for two minutes. Intervention 2: In the second intervention group, non-nutritional stimulation will be done by use of breast twice a day in the morning and in the evening for 10 consecutive days by trained experts. Before stimulation, breast milk will be fully discharged. Also before stimulation hands will be washed with soap and water and latex gloves will be used. Oral stimulation program contains two forms of oral stimulation. Around and in mouth stimulation will be done by hand for three minutes and it will be continue by sucking breast for two minutes. Before, during and after the stimulation, the infant will be monitored by the investigator and stimulation will stop immediately observing any interruption in breathing, slow heart rate and disruption in the oxygen supply. Intervention 3: In the control group, infants will receive non-specialized head and face stimulation in addition to routine nursing care,  as placebo.</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>Narges Majidipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dezful University of Medical Sciences, Azadegan Blv, Dezful, khuzestan, Iran.</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6461895916</zip>
        <telephone>+98 61 4242 9532</telephone>
        <email>info@Dums.ac.ir</email>
        <affiliation>Dezful University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Majidipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dezful University of Medical Sciences, Azadegan Blv, Dezful, Khuzestan, Iran.</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6461895916</zip>
        <telephone>+98 61 4242 9532</telephone>
        <email>info@Duma.ac.ir</email>
        <affiliation>Dezful University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: newborn infant; birth gestational age between 26 to 33 weeks; birth weight &lt; 1500 gr; physiological stability while starting oral stimulation, which means that oral stimulation and start feeding do not make change in the autonomic nervous system (skin color, heart rate and respiratory rate).&#13;
Exclusion criteria: Congenital anomalies; chronic medical problems include bronchopulmonay dysplasia, intraventricular hemorrhage (grade 3 and 4), enterocolitis necrosis and nosocomial Infection during or after oral stimulation program; having seizure in the first 24 hours after birth; being able to natural sucking and oral feeding.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P92.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal difficulty in feeding at breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first intervention group, non-nutritional sucking stimulation will be performed using a pacifier twice a day in the morning and in the evening while doctor start to feed infant. The intervention will be performed for 10 consecutive days by trained expert. Oral stimulation program contains two forms of oral stimulation. Around and in mouth stimulation will be done by hand for three minutes and it will be continued sucking by use of a pacifier for two minutes.</i_keyword>
      <i_keyword>In the second intervention group, non-nutritional stimulation will be done by use of breast twice a day in the morning and in the evening for 10 consecutive days by trained experts. Before stimulation, breast milk will be fully discharged. Also before stimulation hands will be washed with soap and water and latex gloves will be used. Oral stimulation program contains two forms of oral stimulation. Around and in mouth stimulation will be done by hand for three minutes and it will be continue by sucking breast for two minutes. Before, during and after the stimulation, the infant will be monitored by the investigator and stimulation will stop immediately observing any interruption in breathing, slow heart rate and disruption in the oxygen supply.</i_keyword>
      <i_keyword>In the control group, infants will receive non-specialized head and face stimulation in addition to routine nursing care,  as placebo.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time needed to achieve full oral feeding. Timepoint: Seven and ten days after onset of intervention and at the time of discharge. Method of measurement: Counting the number of feedings per day.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: Seven and  ten days after onset of intervention and at the time of discharge. Method of measurement: Model DG-110 Digital Scale.</sec_outcome>
      <sec_outcome>Gestational age. Timepoint: At the time of discharge. Method of measurement: Gestational age at birthday plus the number hospitalization.</sec_outcome>
      <sec_outcome>Hospitalization period. Timepoint: At the time of discharge. Method of measurement: Number of hospitalization days.</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>Dezful University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-29</approval_date>
        <contact_name>Dezful University of Medical Sciences</contact_name>
        <contact_address>Dezful University of Medical Sciences, Azadegan Blv. Dezful  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
