<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03268148</url>
  </required_header>
  <id_info>
    <org_study_id>201700474A3C501</org_study_id>
    <nct_id>NCT03268148</nct_id>
  </id_info>
  <brief_title>Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants</brief_title>
  <official_title>Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants: an Open-label, Randomized-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neonates undergo several painful procedures and these pain experiences can alter clinical&#xD;
      outcome and behavior. The investigators aim to investigate the analgesic effect of low level&#xD;
      laser for procedural pain during heel lancing of term neonates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This open-label, randomized controlled trial involves 130 term newborn infants (gestational&#xD;
      ages between 37 weeks to 42 weeks) who need heel lancing for newborn screening. Subjects are&#xD;
      randomly assigned to low level laser group or breast milk group. Subjects in breast milk&#xD;
      group are given 5ml expressed breast milk by mouth using a syringe tube inserted to the&#xD;
      participant's oral cavity over a 2-minute period. LaserPen is applied to the local point for&#xD;
      20 seconds where heel-lancing will be performed in the low level laser group. Then heel&#xD;
      lancing is performed and two observers who are blinded to the intervention record the&#xD;
      physiological (heart rate and oxygen saturation) and behavioral parameters (duration of&#xD;
      crying and modified neonatal facial coding scores) following the procedure. Heart rate&#xD;
      variation of participants is record by CheckMyHeart ECG monitor. The salivary swab method is&#xD;
      used to detect the infant's salivary cortisol and amylase level as biomarker for stress&#xD;
      evaluation. During the study course, digital cameras continuously record participants'&#xD;
      behavior. Independent t-test, chi-squared test and one way ANOVA are used for statistical&#xD;
      analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>low level laser group and breast milk group</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Two independent assessors blinded to intervention read the video, and then record vital signs and pain score. The videos are cut from heel-lancing to the end so that the assessors do not know whether the neonate receive low level laser or breast milk.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>pain assessment</measure>
    <time_frame>immediately after heel-lancing</time_frame>
    <description>latency of first cry, crying time, squeezing time, neonatal facial coding system(NFCS), Neonatal Pain, Agitation and Sedation Scale (NPASS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>stress biomarker</measure>
    <time_frame>baseline, immediately after heel-lancing, 20 minutes after heel-lancing</time_frame>
    <description>The salivary swab method is used to detect the infant's salivary cortisol and amylase level at 3 time point.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Procedural Pain</condition>
  <arm_group>
    <arm_group_label>low level laser group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LaserPen is applied to the local point for 20 seconds where heel-lancing will be performed in the low level laser group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>breast milk group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in breast milk group are given 5ml expressed breast milk by mouth using a syringe tube inserted to the participant's oral cavity over a 2-minute period before heel-lancing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LaserPen</intervention_name>
    <description>low level laser is used before heel-lancing for newborn screening</description>
    <arm_group_label>low level laser group</arm_group_label>
    <other_name>power 150mW, wavelength 810nm, RJ-laser</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy fullterm neonates (37-42 gestational age)&#xD;
&#xD;
          -  Apgar score &gt;= 7&#xD;
&#xD;
          -  will receive newborn screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &gt;42 or &lt; 37 gestational age&#xD;
&#xD;
          -  perinatal asphyxia&#xD;
&#xD;
          -  major malformations or any other disease that need intensive care&#xD;
&#xD;
          -  drug withdrawal received previous treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Days</minimum_age>
    <maximum_age>4 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bei-yu Wu, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Ou-Yang MC, Chen IL, Chen CC, Chung MY, Chen FS, Huang HC. Expressed breast milk for procedural pain in preterm neonates: a randomized, double-blind, placebo-controlled trial. Acta Paediatr. 2013 Jan;102(1):15-21. doi: 10.1111/apa.12045. Epub 2012 Nov 1.</citation>
    <PMID>23057434</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>February 26, 2020</last_update_submitted>
  <last_update_submitted_qc>February 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Bei-yu Wu</investigator_full_name>
    <investigator_title>Atteding doctor</investigator_title>
  </responsible_party>
  <keyword>neonates</keyword>
  <keyword>pain</keyword>
  <keyword>low level laser</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Procedural</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03268148
org study id: 201700474A3C501
nct id: NCT03268148
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Neonates undergo several painful procedures and these pain experiences can alter clinical
      outcome and behavior. The investigators aim to investigate the analgesic effect of low level
      laser for procedural pain during heel lancing of term neonates.
This open-label, randomized controlled trial involves 130 term newborn infants (gestational
      ages between 37 weeks to 42 weeks) who need heel lancing for newborn screening. Subjects are
      randomly assigned to low level laser group or breast milk group. Subjects in breast milk
      group are given 5ml expressed breast milk by mouth using a syringe tube inserted to the
      participant's oral cavity over a 2-minute period. LaserPen is applied to the local point for
      20 seconds where heel-lancing will be performed in the low level laser group. Then heel
      lancing is performed and two observers who are blinded to the intervention record the
      physiological (heart rate and oxygen saturation) and behavioral parameters (duration of
      crying and modified neonatal facial coding scores) following the procedure. Heart rate
      variation of participants is record by CheckMyHeart ECG monitor. The salivary swab method is
      used to detect the infant's salivary cortisol and amylase level as biomarker for stress
      evaluation. During the study course, digital cameras continuously record participants'
      behavior. Independent t-test, chi-squared test and one way ANOVA are used for statistical
      analysis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: low level laser group and breast milk group
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Two independent assessors blinded to intervention read the video, and then record vital signs and pain score. The videos are cut from heel-lancing to the end so that the assessors do not know whether the neonate receive low level laser or breast milk.
measure: pain assessment
time frame: immediately after heel-lancing
description: latency of first cry, crying time, squeezing time, neonatal facial coding system(NFCS), Neonatal Pain, Agitation and Sedation Scale (NPASS)
measure: stress biomarker
time frame: baseline, immediately after heel-lancing, 20 minutes after heel-lancing
description: The salivary swab method is used to detect the infant's salivary cortisol and amylase level at 3 time point.
arm group label: low level laser group
arm group type: Experimental
description: LaserPen is applied to the local point for 20 seconds where heel-lancing will be performed in the low level laser group.
arm group label: breast milk group
arm group type: No Intervention
description: Subjects in breast milk group are given 5ml expressed breast milk by mouth using a syringe tube inserted to the participant's oral cavity over a 2-minute period before heel-lancing.
intervention type: Device
intervention name: LaserPen
description: low level laser is used before heel-lancing for newborn screening
arm group label: low level laser group
other name: power 150mW, wavelength 810nm, RJ-laser
criteria: 
gender: All
minimum age: 2 Days
maximum age: 4 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Bei-yu Wu, doctor
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
citation: Ou-Yang MC, Chen IL, Chen CC, Chung MY, Chen FS, Huang HC. Expressed breast milk for procedural pain in preterm neonates: a randomized, double-blind, placebo-controlled trial. Acta Paediatr. 2013 Jan;102(1):15-21. doi: 10.1111/apa.12045. Epub 2012 Nov 1.
PMID: 23057434
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Bei-yu Wu
investigator title: Atteding doctor
mesh term: Pain, Procedural
sharing ipd: Undecided