<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/NCT03757871</url>
  </required_header>
  <id_info>
    <org_study_id>P171005J</org_study_id>
    <nct_id>NCT03757871</nct_id>
  </id_info>
  <brief_title>Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera</brief_title>
  <acronym>ELAROP</acronym>
  <official_title>Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain management in premature infants is essential because they are exposed to repeated minor&#xD;
      painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown&#xD;
      its analgesic effectiveness in many studies. Laser acupuncture is a simple, fast,&#xD;
      side-effect-free method, but no study exists on the contribution of acupuncture in the&#xD;
      management of pain caused by the examination of the fundus in addition to conventional&#xD;
      therapies (suction, Glucose G30%, anaesthetic eye drops) which are not sufficiently&#xD;
      effective.&#xD;
&#xD;
      Hypothesis: Laser acupuncture is a medical device that would reduce the pain and discomfort&#xD;
      of premature newborns when examining the fundus with a digital camera.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized, single-centre, randomized, double-blind, randomized, controlled clinical trial in&#xD;
      two parallel groups, acupuncture versus placebo as an add-on to the usual analgesic strategy&#xD;
      (Glucose G 30%/suction and administration of a drop of anesthetic eye drops). The main&#xD;
      objective is to evaluate the contribution of acupuncture versus placebo as an add-on to the&#xD;
      G30% glucose solution 2 minutes before the examination associated with the instillation of a&#xD;
      drop of oxybuprocaine administered 1 minute before the start of the examination on pain&#xD;
      assessed at the first eye fundus (FO) by the score premature infant pain profile (PIPP)&#xD;
      measured before the start of the examination (baseline) and on 30 seconds after the&#xD;
      examination of both eyes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2019</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>score at PIPP (premature infant pain profile) ≥ 10</measure>
    <time_frame>24 hours</time_frame>
    <description>Measurement of pain or discomfort defined by a PIPP score ≥ 10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain and discomfort</measure>
    <time_frame>24 hours</time_frame>
    <description>Assess pain and discomfort (score FANS). The FANS score is a validated hetero-rating scale for assessing acute newborn pain when the face is difficult to analyse. On the 0 to 10 side, the absence of pain is defined by a score &lt; 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate variability</measure>
    <time_frame>24 hours</time_frame>
    <description>assessment of heart rate variability (NIPE score)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Laser Stimulation</condition>
  <arm_group>
    <arm_group_label>Laser Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>laser pen acupuncture projecting an infrared beam with a wavelength of 905nm bilaterally for 30 seconds on each point.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo group will have an application of the pen according to the same extinguished laser criteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser stimulation</intervention_name>
    <description>an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.</description>
    <arm_group_label>Laser Stimulation</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premature from 23+0 to 30sa+6d regardless of birth weight with 1st FO for ROP&#xD;
             screening;&#xD;
&#xD;
          -  Premature birth weights &lt; 1250g with a 1st FO for ROP screening;&#xD;
&#xD;
          -  Informed consent of the holder(s) of parental authority;&#xD;
&#xD;
          -  Child benefiting from a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Analgesic or sedative drug treatment (benzodiazepines, morphine and related) within 48&#xD;
             hours of the examination.&#xD;
&#xD;
          -  Known chromosomal abnormality&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Weeks</minimum_age>
    <maximum_age>31 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farnoux Caroline, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Biran Valerie, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Robert Debré</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>April 28, 2020</last_update_submitted>
  <last_update_submitted_qc>April 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinopathy of Prematurity</mesh_term>
  </condition_browse>
  <!-- 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/NCT03757871
org study id: P171005J
nct id: NCT03757871
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pain management in premature infants is essential because they are exposed to repeated minor
      painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown
      its analgesic effectiveness in many studies. Laser acupuncture is a simple, fast,
      side-effect-free method, but no study exists on the contribution of acupuncture in the
      management of pain caused by the examination of the fundus in addition to conventional
      therapies (suction, Glucose G30%, anaesthetic eye drops) which are not sufficiently
      effective.

      Hypothesis: Laser acupuncture is a medical device that would reduce the pain and discomfort
      of premature newborns when examining the fundus with a digital camera.
Randomized, single-centre, randomized, double-blind, randomized, controlled clinical trial in
      two parallel groups, acupuncture versus placebo as an add-on to the usual analgesic strategy
      (Glucose G 30%/suction and administration of a drop of anesthetic eye drops). The main
      objective is to evaluate the contribution of acupuncture versus placebo as an add-on to the
      G30% glucose solution 2 minutes before the examination associated with the instillation of a
      drop of oxybuprocaine administered 1 minute before the start of the examination on pain
      assessed at the first eye fundus (FO) by the score premature infant pain profile (PIPP)
      measured before the start of the examination (baseline) and on 30 seconds after the
      examination of both eyes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: score at PIPP (premature infant pain profile) ≥ 10
time frame: 24 hours
description: Measurement of pain or discomfort defined by a PIPP score ≥ 10
measure: pain and discomfort
time frame: 24 hours
description: Assess pain and discomfort (score FANS). The FANS score is a validated hetero-rating scale for assessing acute newborn pain when the face is difficult to analyse. On the 0 to 10 side, the absence of pain is defined by a score < 3
measure: heart rate variability
time frame: 24 hours
description: assessment of heart rate variability (NIPE score)
arm group label: Laser Stimulation
arm group type: Experimental
description: laser pen acupuncture projecting an infrared beam with a wavelength of 905nm bilaterally for 30 seconds on each point.
arm group label: Placebo
arm group type: Placebo Comparator
description: The placebo group will have an application of the pen according to the same extinguished laser criteria.
intervention type: Device
intervention name: Laser stimulation
description: an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.
arm group label: Laser Stimulation
arm group label: Placebo
criteria: 
gender: All
minimum age: 23 Weeks
maximum age: 31 Weeks
healthy volunteers: No
last name: Farnoux Caroline, PHD
role: Principal Investigator
affiliation: APHP
last name: Biran Valerie, PHD
role: Study Chair
affiliation: APHP
facility: 
country: France
responsible party type: Sponsor
mesh term: Retinopathy of Prematurity