<?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>IRCT20231120060117N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-17</date_registration>
      <primary_sponsor>College of Nursing, University of Baghdad</primary_sponsor>
      <public_title>Effect of Nesting Technique on Preterm Physiological Indicators</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Nesting Technique Intervention on Preterms Physiological Indicators</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73918</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>Preterm neonate gestational age between 28 – 37 weeks without congenital anomalies and assertive devices..</hc_freetext>
      <i_freetext>Intervention 1: intervention group A: the preterm neonates within the included criteria, will be placed in nesting technique (prone position). for six hours, and check their physiological parameters (temperature, heart rate, respiratory rate) every 2 hours. Intervention 2: Intervention group B: the preterm neonates within the included criteria, will be placed in nesting technique (supine position). for six hours, and check their physiological parameters (temperature, heart rate, respiratory rate) every 2 hours. Intervention 3: Intervention group C: the preterm neonates within the included criteria, will be placed in nesting technique (lateral position). for six hours, and check their physiological parameters (temperature, heart rate, respiratory rate) every 2 hours. Intervention 4: Control group: the preterm neonates within the included criteria, were not placed in the nesting technique, and their physiological parameters (temperature, heart rate, respiratory rate) will be checked every 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:
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.

When:
God willing, once the process of data collection, analysis, and successful publishing of the manuscript, all the related files will become available for 6 months after publication.

To whom:
All the related files will be shared with any scientific interested parties.

Conditions:
It may be used after seeking the author's permission and acknowledging his contribution.

Where to obtain:
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: adraa.hussein@conursing.uobaghdad.edu.iq

How to obtain:
N/A

Comments:
Profound appreciation is due to the IRCT members for their genuine efforts in helping researchers fulfill their academic endeavors.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Adraa Hussein Shawq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bab AL-Muadum</address>
        <city>Baghdad</city>
        <country1>Iraq</country1>
        <zip>10001</zip>
        <telephone>+964 770 263 8810</telephone>
        <email>adraa.hussein@conursing.uobaghdad.edu.iq</email>
        <affiliation>College of Nursing, University of Baghdad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Adraa Hussein Shawq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bab AL-Muadum</address>
        <city>Baghdad</city>
        <country1>Iraq</country1>
        <zip>10001</zip>
        <telephone>+964 770 263 8810</telephone>
        <email>adraa.hussein@conursing.uobaghdad.edu.iq</email>
        <affiliation>College of Nursing, University of Baghdad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Neonates admitted to NICU with spontaneous breathing without the need for assistive devices.
Parents of admitted NICU babies willing to give consent.
preterm without obvious congenital anomalies.
the responsible physician was agreed.</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>14 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>a preterm neonate who was on the ventilator, CPAP, Oxygen, septicemia, seriously ill, and congenital anomalies.
serious illnesses medical or surgical.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O60</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preterm labor</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_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 A: the preterm neonates within the included criteria, will be placed in nesting technique (prone position). for six hours, and check their physiological parameters (temperature, heart rate, respiratory rate) every 2 hours.</i_keyword>
      <i_keyword>Intervention group B: the preterm neonates within the included criteria, will be placed in nesting technique (supine position). for six hours, and check their physiological parameters (temperature, heart rate, respiratory rate) every 2 hours.</i_keyword>
      <i_keyword>Intervention group C: the preterm neonates within the included criteria, will be placed in nesting technique (lateral position). for six hours, and check their physiological parameters (temperature, heart rate, respiratory rate) every 2 hours.</i_keyword>
      <i_keyword>Control group: the preterm neonates within the included criteria, were not placed in the nesting technique, and their physiological parameters (temperature, heart rate, respiratory rate) will be checked every 2 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>More stability physiological parameter (temperature) of preterm neonates. Timepoint: neonates who applied the nesting technique will measure temperature grade pre-test and post-test for two hours for three days consecutively. Method of measurement: direct observational record by using a hospital electronic thermometer.</prim_outcome>
      <prim_outcome>More stability physiological parameter (heart rate) of preterm neonates. Timepoint: neonates who applied the nesting technique will measure heart rate pre-test and post-test for two hours for three days consecutively. Method of measurement: direct observational record by manual counting thorough a pediatric stethoscope.</prim_outcome>
      <prim_outcome>More stability physiological parameter (respiratory rate) of preterm neonates. Timepoint: neonates who applied the nesting technique will measure respiratory rate pre-test and post-test for two hours for three days consecutively. Method of measurement: direct observational record by manual counting of abdominal movement.</prim_outcome>
      <prim_outcome>More stability physiological parameter (oxygen saturation) of preterm neonates. Timepoint: neonates who applied the nesting technique will monitor oxygen saturation pre-test and post-test for two hours for three days consecutively. Method of measurement: direct observational record by monitoring oxygen saturation through a hospital pulse oximeter.</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>The author of the trial is the funding source.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-01</approval_date>
        <contact_name>Research Ethical Approval Committee, at the College of Nursing</contact_name>
        <contact_address>Bab AL-Muadum Baghdad Baghdad Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
