<?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>IRCT20220124053823N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-16</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>"Effect of  Premature Infant Oral Motor Intervention in neonatal outcomes"; "Effect of  Maternal stress in outcomes in neonatal outcomes"</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect between Premature Infant Oral Motor Intervention (PIOMI) and Maternal stress with neonatal outcomes in preterm neonates</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61627</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premature Infant.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:When oral feeding is started in premature infants, the study begins. The volume of milk tolerated will be charted each day and the amount reached to the full volume of milk, ie equivalent to 3 cc per weight, will be calculated as a full fed full cut off. After starting oral feeding, the intervention method was stimulation in the cheeks for 30 seconds and in each species twice, stimulation in the lips for 30 seconds once, budding of the lips for 30 seconds once, gingival stimulation for 30 seconds twice, stimulation of the lateral sides of the tongue and cheeks for 15 seconds once, stimulation of the middle septum of the tongue and palate for 30 seconds twice and finally non-nutritional sucking with a pacifier for two minutes and the rate of respiration and Maternal stress will also be assessed as a questionnaire. Then, the duration of full feeding and the volume of nutritional tolerance and the score of the standard perceived stress questionnaire all before the intervention and three days after the intervention and the day of discharge (to check the reduction of maternal stress) in the checklist for each patient and finally The length of hospital stay is recorded. Intervention 2: Control group: Parents and children receive only routine hospital care. Then, the duration of full feeding and the volume of nutritional tolerance and the score of the standard perceived stress questionnaire all before the intervention and three days after the intervention and the day of discharge (to check the reduction of maternal stress) in the checklist for each patient and finally The length of hospital stay is recorded.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after unidentified individuals.

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions will be available

Conditions:
The use of data is allowed by mentioning the source

Where to obtain:
Afsaneh Akhundzadeh - Sardasht - Arak University of Medical Sciences 3319693345 Aziz_eghbali@yahoo.com Fatemeh Shahjouee No. 23, Kowsar One St., 12 meters from Motahhari., Kohanz., Shahriar., Tehran 3351856639 shahjueefatemeh@gmail.com

How to obtain:
The applicant must first register his / her request through the mentioned communication channels, and after reviewing the request for information, the information will be provided on condition of confidentiality and without identity information. This process will take a minimum of one month and a maximum of 2 months.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Shahjouee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 23, Kowsar One St., 12 meters from Motahhari., Kohanz., Shahriar., Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3351856639</zip>
        <telephone>+98 21 6522 8400</telephone>
        <email>shahjueefatemeh@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afsaneh Akhundzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Third floor., School of medicin Arak University of Medical Sciences., Sardasht,. Arak</address>
        <city>arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319693345</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>Aziz_eghbali@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All premature infants aged 27 to 33 weeks of gestation
Hospitalized in the neonatal intensive care unit
Satisfaction of parents of infants</inclusion_criteria>
      <agemin>189 days</agemin>
      <agemax>231 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Infants with cleft palate, cleft lip and congenital malformation (based on information recorded in the file)
Septicemia
heart disease
Necrotizing enterocolitis
Grade 3 and 4 intraventricular hemorrhage</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preterm newborn, gestational age 28 completed weeks</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:When oral feeding is started in premature infants, the study begins. The volume of milk tolerated will be charted each day and the amount reached to the full volume of milk, ie equivalent to 3 cc per weight, will be calculated as a full fed full cut off. After starting oral feeding, the intervention method was stimulation in the cheeks for 30 seconds and in each species twice, stimulation in the lips for 30 seconds once, budding of the lips for 30 seconds once, gingival stimulation for 30 seconds twice, stimulation of the lateral sides of the tongue and cheeks for 15 seconds once, stimulation of the middle septum of the tongue and palate for 30 seconds twice and finally non-nutritional sucking with a pacifier for two minutes and the rate of respiration and Maternal stress will also be assessed as a questionnaire. Then, the duration of full feeding and the volume of nutritional tolerance and the score of the standard perceived stress questionnaire all before the intervention and three days after the intervention and the day of discharge (to check the reduction of maternal stress) in the checklist for each patient and finally The length of hospital stay is recorded.</i_keyword>
      <i_keyword>Control group: Parents and children receive only routine hospital care. Then, the duration of full feeding and the volume of nutritional tolerance and the score of the standard perceived stress questionnaire all before the intervention and three days after the intervention and the day of discharge (to check the reduction of maternal stress) in the checklist for each patient and finally The length of hospital stay is recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal stress score in the standard perceived stress questionnaire of Cohen et al. Timepoint: Before the intervention and three days after the intervention and the day of discharge. Method of measurement: Perceived stress standard questionnaire.</prim_outcome>
      <prim_outcome>Nutritional tolerance score in the daily chart. Timepoint: قبل از آغاز مداخله و سه روز بعد از مداخله و روز ترخیص. Method of measurement: View.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-19</approval_date>
        <contact_name>Ethics committee of arak University of Medical Sciences</contact_name>
        <contact_address>Third Floor., Imam Musa Kazem Building., University Complex of the Great Prophet (PBUH)., Basij Square., Sardasht Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
