<?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>IRCT20190326043115N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-06</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Swaddling bathing on Oxygen needs  in premature neonates with chronic lung disease (CLD)</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Swaddling bathing on oxygen needs and physiologic parameters (body temperature, HR and RR) among premature neonates with chronic lung disease (CLD): a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38643</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random numbers table will be used to randomly assign people to study groups. Each participant is assigned a code, and then, by selecting a one-digit refinement on the random number table and moving to a specific side on the number table, the required number of people in each group is determined. The even numbers will be allocated to the intervention group and the odds numbers to the control group, Blinding description: The study is planned in such a way that the data analyzer does not know which study group is control or experimental groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The need for oxygen in infants with chronic lung disease (CLD)..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, infants are bathed three times, once a day, at a certain time of the day, according to the Swaddle Bathing protocol in the bathtub. Oxygen requirements, body temperature, respiration rate and heart rate will be measured 10 minutes before, 10 minutes and 1 hour after bathing. Room temperature is 26-27 degrees Celsius and water temperature is 38 to 40 degrees Celsius. The bath time is between 6-8 minutes before the baby's feeding time and with the presence, support and participation of at least one parent. The baby's body temperature is fully monitored during the bath to avoid hypothermia and to control stressful symptoms. Bathing will be done using a bathtub, shampoo and other special equipment and in full compliance with the baby's bath protocol as well as hygienic instructions. After bathing, we prepare the baby for nourishment and skin-to-skin contact with the mother. Intervention 2: Control group: There is no intervention in the control group, but the amount of oxygen required, body temperature, number of breaths and heart rate 10 minutes before and 10 minutes and 1 hour after bathing as the intervention group (three times, one day in Intermediate will be measured at a set time of day.</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:
Information about age, sex, weight, height, multiple children, smoking mother and mother demographic profile.

When:
Since 1399

To whom:
Researchers, doctors and nurses and medical centers

Conditions:
Research development and improvement in treatment routine

Where to obtain:
Tabriz University of Medical Sciences, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences

How to obtain:
Written request from Tabriz University of Medical Sciences, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences. Visit the center in person

Comments:
I do not have</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Zad Mahmoud</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 112; 2 closed alley; 11 alley; Koie Janbazan</address>
        <city>Ajabshir</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5541635631</zip>
        <telephone>+98 41 3762 1302</telephone>
        <email>zadmahmood61@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Arshadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz School of Nursing and Midwifery; South Shariati street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947-977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>arshadi9429@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Preterm infants with CLD hospitalized in the NICU (infants in need of oxygen for more than 28 days and reaching a calendar age of 32 to 36 weeks (Postconceptional Age))
Has received oxygen
At least one parent is present during the bath
Physiological stability at the start of the study (in the last 24 hours there is no decreased saturation, hypothermia, decreased or increased heart rate)
Bathing instructions by a neonatal subspecialist
The venous line is cut off</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a congenital anomaly
Any type of wound, including surgical wounds on the skin</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J06</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute upper respiratory infections of multiple and unspecified sites</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, infants are bathed three times, once a day, at a certain time of the day, according to the Swaddle Bathing protocol in the bathtub. Oxygen requirements, body temperature, respiration rate and heart rate will be measured 10 minutes before, 10 minutes and 1 hour after bathing. Room temperature is 26-27 degrees Celsius and water temperature is 38 to 40 degrees Celsius. The bath time is between 6-8 minutes before the baby's feeding time and with the presence, support and participation of at least one parent. The baby's body temperature is fully monitored during the bath to avoid hypothermia and to control stressful symptoms. Bathing will be done using a bathtub, shampoo and other special equipment and in full compliance with the baby's bath protocol as well as hygienic instructions. After bathing, we prepare the baby for nourishment and skin-to-skin contact with the mother.</i_keyword>
      <i_keyword>Control group: There is no intervention in the control group, but the amount of oxygen required, body temperature, number of breaths and heart rate 10 minutes before and 10 minutes and 1 hour after bathing as the intervention group (three times, one day in Intermediate will be measured at a set time of day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxygen needs. Timepoint: It will be measured three times at certain times of the day, every other day, 10 minutes before and 10 minutes and 1 hour after bathing. Method of measurement: In measuring the need for oxygen, the concentration of saturated oxygen using a blender and the duration of oxygen therapy per day will be measured using a finger oxygen meter that is fixed to the baby's foot.</prim_outcome>
      <prim_outcome>Body temperature. Timepoint: It will be measured three times at certain times of the day, every other day, 10 minutes before and 10 minutes and 1 hour after bathing. Method of measurement: Using a digital armpit thermometer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: It will be measured three times at certain times of the day, every other day, 10 minutes before and 10 minutes and 1 hour after bathing. Method of measurement: Using a finger probe connected to the monitor.</prim_outcome>
      <prim_outcome>Respiratory Rate. Timepoint: It will be measured three times at certain times of the day, every other day, 10 minutes before and 10 minutes and 1 hour after bathing. Method of measurement: By observing and counting chest movements.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-20</approval_date>
        <contact_name>Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery; South Shariati street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
