<?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>IRCT20140610018046N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-16</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Sleep in premature neonates</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mother’s bosom like position on the duration of sleep in premature neonates.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47706</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Education/Guidance, Other design features: A crossover design selected to reduce the effect of interfering factors, Randomization description: Sampling in this study was performed by continuous sampling . Eligible infants were randomly assigned to quadruple blockade in two intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sleep in premature neonates..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After feeding and connecting the electrodes, the baby was first placed in a nest appropriate for his size in the same position as the mother's arms, and his brain tape was recorded for 2 hours using an aEEG device. To prevent the effect of the intervention in the control group, the infant was placed in the wash out stage for 2 hours, and the electrodes were reconnected to his head and placed in his nest lying on his stomach while his head was turned to one side. Similarly, his brain tape was recorded by the aEEG device within 2 hours. Due to the fact that the research environment was low traffic between 14:00 and 20:00 and the number of medical procedures and nursing care was minimal, the study was conducted during this period. Intervention 2: Control group:In the control group, immediately after feeding, three electrodes of the aEEG device were attached to the infant's head and the infant was lying on its stomach for 2 hours with the head turned to one side and in the normal and routine position in the nest in proportion to the body. His brain tape was recorded during these 2 hours.</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:
-Will be done upon request

When:
August 2020

To whom:
Research team

Conditions:
Better care than premature baby

Where to obtain:
Nursing Care Research Center

How to obtain:
Send a request to the head of the Nursing Care Research Center

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sedigheh khanjari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Care Research center,  Building of Nursing and Midwifery in front of Khatam Al-Nabia Hospital,  Rashid Yasemi Ave. Above Vanak Sq, Valiasr Ave.,Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 8867 1613</telephone>
        <email>khanjari.s@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedigheh khanjari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Care Research center, Building of Nursing and Midwifery in front of Khatam Al-Nabia Hospital, Rashid Yasemi Ave. Above Vanak Sq, Valiasr Ave.,Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 8867 1613</telephone>
        <email>khanjari.s@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnancy age 31 to 34 weeks; Birth weight 1500 to 2000 kg; Feed the baby every 2 hours; No restriction on position change; Self-breathing without the need for respiratory support; Lack of congenital disease or brain defects such as intraventricular hemorrhage; Do not use sedatives 24 hours before the study; Failure to perform painful invasive interventions such as vessel sampling or sampling 12 hours before the start of the study; Do not use phototherapy; Failure to use tobacco by the mother or substance abuse during pregnancy; Normal blood sugar</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>15 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Need immediate medical attention while studying
Blood infection
Seizures</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>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After feeding and connecting the electrodes, the baby was first placed in a nest appropriate for his size in the same position as the mother's arms, and his brain tape was recorded for 2 hours using an aEEG device. To prevent the effect of the intervention in the control group, the infant was placed in the wash out stage for 2 hours, and the electrodes were reconnected to his head and placed in his nest lying on his stomach while his head was turned to one side. Similarly, his brain tape was recorded by the aEEG device within 2 hours. Due to the fact that the research environment was low traffic between 14:00 and 20:00 and the number of medical procedures and nursing care was minimal, the study was conducted during this period.</i_keyword>
      <i_keyword>Control group:In the control group, immediately after feeding, three electrodes of the aEEG device were attached to the infant's head and the infant was lying on its stomach for 2 hours with the head turned to one side and in the normal and routine position in the nest in proportion to the body. His brain tape was recorded during these 2 hours</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Situation of sleep in immature neonate. Timepoint: The first week. Method of measurement: Amplitude-integrated Electroencephalography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mother’s bosom like position on the duration of sleep in premature neonates. Timepoint: Immediately after feeding for two hours in the supine position on the baby's nest. Method of measurement: Sleep status was evaluated by aEEG.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-28</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
