<?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>IRCT20210109049974N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-11</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of kangaroo mother care and tactile-kinesthetic stimulation on weight gain of late preterm infants in hospitalized in neonatal intensive care units.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of kangaroo mother care and tactile-kinesthetic stimulation on weight gain of late preterm infants in hospitalized in neonatal intensive care units in the Mousavi hospital affiliated to Zanjan University of Medical Sciences. 2020. :A Randomized Clinical Trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54290</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The function of random numbers was used to randomize and assign people to groups; Randomization using Excel software is as follows:
First, in one column, the groups are entered as A, B, c and below; Because the number of samples in each group is set to 30 (including sample loss), therefore, 30, B, A c should be entered in order. In the opposite column, random numbers are generated using the RAND command. In the next step, using the sort command, the generated random numbers are sorted from small to large or vice versa, which changes the order of the groups, i.e. c A, B. Using the new order, people are assigned to different groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Maternal kangaroo care and kinetic tactile stimulation.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: in the tactile-kinetic stimulation intervention group, late preterm infants will receive tactile-kinetic stimulation three times a day (morning, noon, night) for 15 minutes for 7 days. This intervention will be performed by mothers on babies in three 5-minute stages. The stages of the intervention will be as follows:- The first stage: (touch stage) which was done in the palm position and relatively strong tactile stimuli applied by the palms of the baby's mother on the baby's head, neck, shoulders and back It was found that these stimulations lasted for 5 seconds in each turn of tactile stimulation and the duration of this stage was 5 minutes. The firmness that is applied by the palms of the baby's mother on the forehead, cheeks, chest, abdomen, upper and lower limbs, palms and feet of the baby. This stage should last 5 minutes. The third stage: (Kinetic stage) This stage of tactile stimulation will be done in the open arch position and includes passive movements of bending and straightening the upper limbs in the shoulder and elbow joints and the lower limbs in It is the location of the hip, knee and ankle joints. These passive movements will be performed 5 times in each joint, each movement will last 2 seconds and the total time for this step will be 5 minutes. Intervention 2: The second intervention group: In the mother's kangaroo care intervention group, the late preterm babies will be placed on the mother's chest by the relevant nurse for 7 days and 3 times a day for 60 minutes, and there will be skin contact between the mother and the baby. The nude that is in a stable physiological condition will be established. Intervention 3: Control group: In this research, the control group will be late premature babies who are hospitalized in the neonatal intensive care unit and receive the usual nursing interventions.</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>Soheila Mirloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alley of culture, Sepehr residential complex, phase 2, block 6, 7th floor, unit 3</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4519949858</zip>
        <telephone>+98 24 3352 9480</telephone>
        <email>mirlous08@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Lida Nick Farid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Vali Asr St. - Niayesh Intersection - in front of Shahid Rajaei Heart Hospital - School of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>l.nikfarid@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Fetal age 34-37 weeks
Hemodynamic stability
Feeding through the digestive system (oral or digestive tube) with breast milk or formula
Staying in the neonatal intensive care unit for at least one week
Birth of a singleton
Iranian nationality
The presence of the biological mother, who is literate and willing and able to perform interventions correctly in the hospital</inclusion_criteria>
      <agemin>238 days</agemin>
      <agemax>259 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Discharge the baby before the end of the intervention
Transfer to another department before the end of the intervention
Having a diagnosis of genetic, cardiac, respiratory, central nervous system problems (acquired and congenital)
The need for any surgery
Having a history of intrauterine growth retardation
History of substance abuse in the mother</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: in the tactile-kinetic stimulation intervention group, late preterm infants will receive tactile-kinetic stimulation three times a day (morning, noon, night) for 15 minutes for 7 days. This intervention will be performed by mothers on babies in three 5-minute stages. The stages of the intervention will be as follows:- The first stage: (touch stage) which was done in the palm position and relatively strong tactile stimuli applied by the palms of the baby's mother on the baby's head, neck, shoulders and back It was found that these stimulations lasted for 5 seconds in each turn of tactile stimulation and the duration of this stage was 5 minutes. The firmness that is applied by the palms of the baby's mother on the forehead, cheeks, chest, abdomen, upper and lower limbs, palms and feet of the baby. This stage should last 5 minutes. The third stage: (Kinetic stage) This stage of tactile stimulation will be done in the open arch position and includes passive movements of bending and straightening the upper limbs in the shoulder and elbow joints and the lower limbs in It is the location of the hip, knee and ankle joints. These passive movements will be performed 5 times in each joint, each movement will last 2 seconds and the total time for this step will be 5 minutes.</i_keyword>
      <i_keyword>The second intervention group: In the mother's kangaroo care intervention group, the late preterm babies will be placed on the mother's chest by the relevant nurse for 7 days and 3 times a day for 60 minutes, and there will be skin contact between the mother and the baby. The nude that is in a stable physiological condition will be established.</i_keyword>
      <i_keyword>Control group: In this research, the control group will be late premature babies who are hospitalized in the neonatal intensive care unit and receive the usual nursing interventions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: Before study, during study, after study. Method of measurement: Digital baby measuring scales.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-15</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>no.3,7th floor,block6,The residential complex of Farhang Town  sepehr, Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
