<?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>IRCT20100411003679N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-30</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating of Two Nutrition Methods Cup Feeding and Finger feeding on Weight Gain and Nutrition Tolerance in Preterm Infants</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating of Two Nutrition Methods Cup Feeding and Finger feeding on Weight Gain and Nutrition Tolerance in Preterm Infants hospitalized in  neonatal intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>87</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53251</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For random allocation of samples,the lottery method was used .three identical envelopes were prepared and a number was placed in each envelope, with number 1 representing infants with cups, experimental group 2 representing infants with a finger, and in control group 3 infants fed by routine method, Then one of the nurses who was not aware of the contents of the envelope was asked to choose one of the envelopes and the group of infants is determined according to the number in the envelope, Blinding description: The research assistant nurse was not aware of the group research to record information about nutrition and weight tolerance. Also, the data analysis expert was unaware of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>weighning and feeding tolerance.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Infants was fed by cup 4 times a day for 7 days, each time for 15-20 minutes. In this group, the infants were kept securely in a blanket in a sitting or semi-sitting position, and the infant's body was placed level. The milk from the mother or from the human milk bank was placed in a small cup, usually 30 to 50 cc in size, with the edge of the cup tangential to the baby's lower lip. With the movements of the tongue, the baby began to suckle. Feeding was completed when the predetermined volume of milk was consumed. The rate of rejection of milk or wasted milk by weighing the gas placed under the chin by a digital scale with a sensitivity of one tenth of a gram, which differed from the weight of infants Weighed. Intervention 2: Intervention group: The finger feeding technique was performed in a manner similar to that described by Fuji Naga et al., 2016. First, the tip of the feeding tube was cut and fixed with adhesive tape into the little finger of the glove. The finger pad was then inserted upwards into the baby's mouth and in front of the roof of his mouth. As the baby began to suck his finger, he gently pressed the plunger onto the syringe and the milk was drawn into the baby's mouth. So, the baby was eager to suck and swallow milk. Intervention 3: Control group: In the control group, feeding was performed routinely. In the routine method, infants were fed by droppers. In the drip feeding, the baby's head and torso were placed at an angle of 35 to 45 degrees and the prescribed amount of milk was reduced from the volume of the gavage and given with the drip.</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>khadijeh dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali St., Shahid Sadoughi School of Nursing and Midwifery, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>info@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>khadijeh dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safaieh, Bouali St., Shahid Sadoughi School of Nursing and Midwifery, Yazd</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>dehghanish@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>gestational age 32-36 weeks
inability to breast feeding</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>term and post term infants
feeding in other ways before the study
neonates with  neural  and cardiac and respiratory abnormalities, congenital diseases of the head and neck, necrotizing enterocolitis, genetic syndromes
infants in need of resuscitation, Apgar score less than 5 in the 5 minute, infants in need of mechanical ventilation
Grade 3 and 4 intracranial hemorrhage, sepsis, respiratory disorders</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>Intervention group: Infants was fed by cup 4 times a day for 7 days, each time for 15-20 minutes. In this group, the infants were kept securely in a blanket in a sitting or semi-sitting position, and the infant's body was placed level. The milk from the mother or from the human milk bank was placed in a small cup, usually 30 to 50 cc in size, with the edge of the cup tangential to the baby's lower lip. With the movements of the tongue, the baby began to suckle. Feeding was completed when the predetermined volume of milk was consumed. The rate of rejection of milk or wasted milk by weighing the gas placed under the chin by a digital scale with a sensitivity of one tenth of a gram, which differed from the weight of infants Weighed.</i_keyword>
      <i_keyword>Intervention group: The finger feeding technique was performed in a manner similar to that described by Fuji Naga et al., 2016. First, the tip of the feeding tube was cut and fixed with adhesive tape into the little finger of the glove. The finger pad was then inserted upwards into the baby's mouth and in front of the roof of his mouth. As the baby began to suck his finger, he gently pressed the plunger onto the syringe and the milk was drawn into the baby's mouth. So, the baby was eager to suck and swallow milk.</i_keyword>
      <i_keyword>Control group: In the control group, feeding was performed routinely. In the routine method, infants were fed by droppers. In the drip feeding, the baby's head and torso were placed at an angle of 35 to 45 degrees and the prescribed amount of milk was reduced from the volume of the gavage and given with the drip.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average weight of premature infants. Timepoint: The mean weight of premature infants in three groups was measured before the intervention and then daily at the beginning of the morning shift before feeding and after the intervention. Method of measurement: The weight of uncoated infants was measured by a special weight scale for infants with zyklus med model and an accuracy factor of 5 grams by the researcher from trained personnel working in the department and recorded in a special form.</prim_outcome>
      <prim_outcome>Percentage of feeding tolerance of premature infants. Timepoint: Before the start of each feeding. Method of measurement: To evaluate the feeding tolerance of infants, before the start of each feeding, the remaining amount of milk was measured using a syringe attached to the gastric catheter by gastric lavage. If this rate was more than 30% of breastfed or any of the clinical symptoms such as distension, vomiting, blood in the stool and fecal remnants, the cause of intolerance to nutrition was considered and recorded in the registration form.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-05</approval_date>
        <contact_name>Ethics.research.ac.ir</contact_name>
        <contact_address>Bahonar Square, the central building of Yazd University of Medical Sciences yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
