<?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>IRCT20220302054171N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-09</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness feeding methods in premature infants</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of two methods of finger feeding and cup feeding on the weight gain and achieve to independent oral nutrition premature infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62313</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be placed in intervention and control groups by the limited randomization method called "Random allocation rule"; In this way, 90 color cards identifying the study groups (red card of intervention 1, blue card of intervention 2 and white card of control group) will be prepared for the total number of patients studied and the patient will be selected based on the color cards. Eligible will be placed in groups, Blinding description: Due to the fact that only the diagnosis and decision about starting oral feeding and the number of times of oral feeding per day is made by the neonatologist present in the ward, so they will not be aware of the allocation of subjects in the two intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Weight gain and achievement of independent oral nutrition in premature infants.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: The meaning of cup feeding is that breast milk is prepared in a graduated plastic cup from Espadana company. While sitting, hold the baby slightly backwards, hold the cup of milk in front of the baby's lips, and gently place it on the baby's lower lip in the gap between the lower lip and gums. Then tilt the cup so that the milk reaches the baby's lips. The premature baby eats the milk from the cup with forward movements of the tongue. Intervention 2: Second Intervention group: For finger feeding, this is how it is done: Tube number five is used, which is fixed with a thin adhesive tape on the little finger of the researcher, one end of which is attached to the finger and the other end to the 5 cc of Laurel Ava syringe. Hold the baby upright and gently pour the milk into the baby's mouth each time, with the milk between the gums and cheeks or on the baby's tongue. The baby is then allowed to swallow the milk. Intervention 3: Control group: Receive routine ward care.</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>Mahin Naderifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of Medical Sciences, Dr. Hesabi Square</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3329 5765</telephone>
        <email>fa.mirzaei.997@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Naderifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of Medical Sciences, Dr. Hesabi Square</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3329 5765</telephone>
        <email>fa.mirzaei.997@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Stable clinical condition
Gestational age from 30 to 35 weeks
Receive OGT feeding completely</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>28 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Infants with a history of underlying diseases
Infants with sedative Receive
Infants with neurological diseases and congenital head and neck abnormalities
Infants with genetic syndromes
Infants with underlying diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group: The meaning of cup feeding is that breast milk is prepared in a graduated plastic cup from Espadana company. While sitting, hold the baby slightly backwards, hold the cup of milk in front of the baby's lips, and gently place it on the baby's lower lip in the gap between the lower lip and gums. Then tilt the cup so that the milk reaches the baby's lips. The premature baby eats the milk from the cup with forward movements of the tongue.</i_keyword>
      <i_keyword>Second Intervention group: For finger feeding, this is how it is done: Tube number five is used, which is fixed with a thin adhesive tape on the little finger of the researcher, one end of which is attached to the finger and the other end to the 5 cc of Laurel Ava syringe. Hold the baby upright and gently pour the milk into the baby's mouth each time, with the milk between the gums and cheeks or on the baby's tongue. The baby is then allowed to swallow the milk.</i_keyword>
      <i_keyword>Control group: Receive routine ward care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weigh gain of premature infants through the Beurer calibrated scale in the neonatal intensive care unit. Timepoint: Weight measurement at the beginning of the intervention and 72 hours after feeding. Method of measurement: Beurer calibrated scales.</prim_outcome>
      <prim_outcome>Achieve to independent oral nutrition. Timepoint: Assessing the frequency of achieving oral independence 72 hours after the start of the nutritional intervention. Method of measurement: Breastfeeding.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adequacy of nutrition. Timepoint: Before the intervention and 72 hours after the intervention. Method of measurement: Calibrated cup of Espadana company.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-17</approval_date>
        <contact_name>Research Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Main campus of medical sciences, Dr. Hesabi Square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
