<?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>IRCT20191215045749N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-29</date_registration>
      <primary_sponsor>Vice chancellor for research, Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of oral sucrose on Premature Newborns pain ";" The effect of kangaroo Mother care on Premature Newborns pain; "</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of oral sucrose application and kangaroo Mother care on some physiological variables and pain of venous blood sampling in premature Newborns admitted to Neonatal Intensive Care Units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46284</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, intravenous blood sampling is performed between 8 am and 9 am by a skilled and experienced neonatal staff in each hospital who is considered as a research assistant and will be stable during the study.Couples of the week will be referred to Hafez Hospital and individual days to Hazrat Zeinab Hospital for sampling, Randomization description: The neonatal randomization was based on 3-digit permutation block method.
ABC
ACB
BCA
BAC
CBA
CAB
C: infants in control group    A: infants in kangaroo care group  B: Infants in oral sucrose group, Blinding description: In the two experimental groups, the pain score was assessed by a nurse colleague with experience of working in the neonatal ward and not knowing the allocation of samples to the relevant groups by using the Neonatal Infant Pain Scale (NIPS). He is well trained. The nurse will assess the pain score by examining the recorded videos.</study_design>
      <phase>3</phase>
      <hc_freetext>Pain from intravenous blood sampling in premature newborns.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Newborns in kangaroo care group receive kangaroo Mother Care 30 minutes before intravenous blood sampling. Intervention 2: Intervention group: In neonates of oral sucrose group, 2 min before intravenous blood sampling 0.5 ml of 24% oral sucrose solution is poured onto the anterior part of the tongue using a syringe. Intervention 3: Control group: In the control group, routine care will be taken and will not receive any intervention before venous blood sampling.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narjes Nasri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery of Fatemeh, Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936-13119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>n_nasri@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences- Fatemeh School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zahra Hadian Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh School of Nursing and Midwifery, Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936-13119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>zhadian@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences - Fatemeh Nursing and Midwifery School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Premature Infants with Gestational Age of 28-37( Infant Age not exceeding 37 weeks after Birth) with stable clinical status.
Birth weight 1500 grams or more
Absence of cardiac, respiratory, infectious, neurological and metabolic defects
Apgar score of 7-10 at the first and fifth minutes
Feeding the baby from the mouth.
Failure to take painful measures one hour before starting study
No intrauterine growth retardation
Having a sucking reflex and response to painful stimulation.
No infant with diabetes
No necrotizing enterocolitis
No use of pharmacological and non-pharmacological measures of pain control during the past 24 hours
Age after birth 48 hours or more, so that the corrected age should not exceed 37 weeks.
Maternal non-addiction to cigarettes, alcohol, and drugs during pregnancy.
Moms with a good general outlook and a willingness to cooperate and not have a specific underlying illness in the mother</inclusion_criteria>
      <agemin>7 months</agemin>
      <agemax>8 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Blood sampling from more than one place.</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>Intervention group: Newborns in kangaroo care group receive kangaroo Mother Care 30 minutes before intravenous blood sampling</i_keyword>
      <i_keyword>Intervention group: In neonates of oral sucrose group, 2 min before intravenous blood sampling 0.5 ml of 24% oral sucrose solution is poured onto the anterior part of the tongue using a syringe.</i_keyword>
      <i_keyword>Control group: In the control group, routine care will be taken and will not receive any intervention before venous blood sampling</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Score. Timepoint: 5 minutes before, during and 5 minutes after venous blood sampling. Method of measurement: Neonatal Infant Pain Scale.</prim_outcome>
      <prim_outcome>Respiration Rate. Timepoint: 5 minutes before, during and 5 minutes after venous blood sampling. Method of measurement: Oximeter Pulse.</prim_outcome>
      <prim_outcome>Heart Rate. Timepoint: 5 minutes before, during and 5 minutes after venous blood sampling. Method of measurement: Oximeter Pulse.</prim_outcome>
      <prim_outcome>Percentage of Arterial Blood Oxygen. Timepoint: 5 minutes before, during and 5 minutes after venous blood sampling. Method of measurement: Oximeter Pulse.</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>Vice chancellor for research, Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-15</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
