<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/NCT04440462</url>
  </required_header>
  <id_info>
    <org_study_id>RC 13/2019</org_study_id>
    <nct_id>NCT04440462</nct_id>
  </id_info>
  <brief_title>Analgesia in Lingual Frenulotomy in the Newborn</brief_title>
  <acronym>RE-GLU</acronym>
  <official_title>Lingual Frenulotomy in the Newborn: a Randomized Clinical Trial to Evaluate the Analgesic Effect of a Water and Sugar Solution in a Minor Surgical Procedure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Burlo Garofolo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Burlo Garofolo</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ankyloglossia (tongue-tie) is a congenital anomaly characterized by a short lingual frenulum&#xD;
      that limits the physiological tongue movement and occurs with an estimated prevalence between&#xD;
      4 and 10% of the newborns. This condition can be associated with difficulty in breastfeeding&#xD;
      which can be painful for the mother, dysfunctional swallowing and future speech difficulties.&#xD;
      The prevalence of nipple pain among women breastfeeding newborns with ankyloglossia is&#xD;
      estimated to be between 36 and 80%. Since an early intervention can prevent the difficulties&#xD;
      that may occur during the child's growth and can also improve the mothers and patients'&#xD;
      quality of life, it is important to evaluate the lingual frenulum in the first days of life.&#xD;
      The treatment of ankyloglossia consists in the frenulotomy which allows the release of the&#xD;
      lingual frenulum and is a relatively simple procedure with few side effects and minimal&#xD;
      post-operative. Different methods performed with or without local anaesthesia by means of&#xD;
      scissors, blade, laser (etc.) are described in literature for the procedure the newborn.&#xD;
&#xD;
      The hypothesis of the study is that the addition of a water and sugar solution to the&#xD;
      standard analgesia with lidocaine may lead to a greater benefit in terms of pain control and&#xD;
      determine the activation of different brain areas.&#xD;
&#xD;
      The primary aim of the study is to evaluate whether the administration of a water and sugar&#xD;
      solution to newborns undergoing frenulotomy receiving topical lidocaine as standard analgesic&#xD;
      protocol, may lead to an additional benefit in terms of pain reduction evaluated according to&#xD;
      the Neonatal Infant Pain Scale (NIPS).&#xD;
&#xD;
      The secondary aim of the study is to evaluate through a Hitachi multichannel near-infrared&#xD;
      spectroscopy (NIRS) the effects of the addition of a water and sugar solution to the standard&#xD;
      analgesic protocol with topical lidocaine on the cortical activation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 18, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain reduction</measure>
    <time_frame>30 seconds after the frenulotomy</time_frame>
    <description>The perception of pain in newborns will be evaluated according to the Internationally Validated Neonatal Infant Pain Scale (NIPS).This scale detects the presence of six behavioral expression signs of neonatal pain (facial expression, crying, respiratory pattern, arms and legs' activity, arousal state) and ranges from 0 (absence of pain) to 7 (maximal pain level).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain reduction</measure>
    <time_frame>During the frenulotomy</time_frame>
    <description>The perception of pain in newborns will be evaluated according to the Internationally Validated Neonatal Infant Pain Scale (NIPS).This scale detects the presence of six behavioral expression signs of neonatal pain (facial expression, crying, respiratory pattern, arms and legs' activity, arousal state) and ranges from 0 (absence of pain) to 7 (maximal pain level).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortical oxy-haemoglobin change</measure>
    <time_frame>30 seconds after the frenulotomy</time_frame>
    <description>Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2) (Hitachi multichannel NIRS system)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Frenulum Breve</condition>
  <arm_group>
    <arm_group_label>Sugar and water solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 ml of a water and sugar solution (3 full-teaspoons of granulated sugar dissolved in half glass of water)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sterile water</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 ml of sterile water</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sugar and water solution</intervention_name>
    <description>2 ml of a water and sugar solution (3 full-teaspoons of granulated sugar dissolved in half glass of water)</description>
    <arm_group_label>Sugar and water solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sterile water</intervention_name>
    <description>2 ml of sterile water</description>
    <arm_group_label>Sterile water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Term newborns (37 - 41 weeks of gestational age) within the first 10 days of life;&#xD;
&#xD;
          2. Birth weight ≥ 2500 grams;&#xD;
&#xD;
          3. Presence of ankyloglossia;&#xD;
&#xD;
          4. Indication to the frenulotomy according to the Hazelbaker Assessment Tool for Lingual&#xD;
             Frenulum Function (HATLFF): anatomical-functional evaluation with a score lower than&#xD;
             8.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Syndromic diagnosis (genetic/hereditary);&#xD;
&#xD;
          2. Pathology of main organ (heart disease, brain disease etc.);&#xD;
&#xD;
          3. Drugs intake that may interfere with the collected data (sedatives).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>10 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maddalena Chermetz, DDS MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for maternal and child health Burlo Garofolo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Milena Cadenaro, DDS MSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>Institute for maternal and child health Burlo Garofolo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chiara Navarra, DDS MSc PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for maternal and child health Burlo Garofolo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Milena Cadenaro, DDS MSc PhD</last_name>
    <phone>+390403785675</phone>
    <email>milena.cadenaro@burlo.trieste.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chiara Navarra, DDS MSc PhD</last_name>
    <phone>+390403785675</phone>
    <email>chiara.navarra@burlo.trieste.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute for Maternal and Child Health - IRCCS Burlo Garofolo-</name>
      <address>
        <city>Trieste</city>
        <zip>34137</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Milena Cadenaro</last_name>
      <email>milena.cadenaro@burlo.trieste.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ankyloglossia</keyword>
  <keyword>Frenulotomy</keyword>
  <keyword>water and sugar solution</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT04440462
org study id: RC 13/2019
nct id: NCT04440462
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Ankyloglossia (tongue-tie) is a congenital anomaly characterized by a short lingual frenulum
      that limits the physiological tongue movement and occurs with an estimated prevalence between
      4 and 10% of the newborns. This condition can be associated with difficulty in breastfeeding
      which can be painful for the mother, dysfunctional swallowing and future speech difficulties.
      The prevalence of nipple pain among women breastfeeding newborns with ankyloglossia is
      estimated to be between 36 and 80%. Since an early intervention can prevent the difficulties
      that may occur during the child's growth and can also improve the mothers and patients'
      quality of life, it is important to evaluate the lingual frenulum in the first days of life.
      The treatment of ankyloglossia consists in the frenulotomy which allows the release of the
      lingual frenulum and is a relatively simple procedure with few side effects and minimal
      post-operative. Different methods performed with or without local anaesthesia by means of
      scissors, blade, laser (etc.) are described in literature for the procedure the newborn.

      The hypothesis of the study is that the addition of a water and sugar solution to the
      standard analgesia with lidocaine may lead to a greater benefit in terms of pain control and
      determine the activation of different brain areas.

      The primary aim of the study is to evaluate whether the administration of a water and sugar
      solution to newborns undergoing frenulotomy receiving topical lidocaine as standard analgesic
      protocol, may lead to an additional benefit in terms of pain reduction evaluated according to
      the Neonatal Infant Pain Scale (NIPS).

      The secondary aim of the study is to evaluate through a Hitachi multichannel near-infrared
      spectroscopy (NIRS) the effects of the addition of a water and sugar solution to the standard
      analgesic protocol with topical lidocaine on the cortical activation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain reduction
time frame: 30 seconds after the frenulotomy
description: The perception of pain in newborns will be evaluated according to the Internationally Validated Neonatal Infant Pain Scale (NIPS).This scale detects the presence of six behavioral expression signs of neonatal pain (facial expression, crying, respiratory pattern, arms and legs' activity, arousal state) and ranges from 0 (absence of pain) to 7 (maximal pain level).
measure: Pain reduction
time frame: During the frenulotomy
description: The perception of pain in newborns will be evaluated according to the Internationally Validated Neonatal Infant Pain Scale (NIPS).This scale detects the presence of six behavioral expression signs of neonatal pain (facial expression, crying, respiratory pattern, arms and legs' activity, arousal state) and ranges from 0 (absence of pain) to 7 (maximal pain level).
measure: Cortical oxy-haemoglobin change
time frame: 30 seconds after the frenulotomy
description: Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2) (Hitachi multichannel NIRS system)
arm group label: Sugar and water solution
arm group type: Experimental
description: 2 ml of a water and sugar solution (3 full-teaspoons of granulated sugar dissolved in half glass of water)
arm group label: Sterile water
arm group type: Active Comparator
description: 2 ml of sterile water
intervention type: Other
intervention name: Sugar and water solution
description: 2 ml of a water and sugar solution (3 full-teaspoons of granulated sugar dissolved in half glass of water)
arm group label: Sugar and water solution
intervention type: Other
intervention name: Sterile water
description: 2 ml of sterile water
arm group label: Sterile water
criteria: 
gender: All
minimum age: 1 Day
maximum age: 10 Days
healthy volunteers: No
last name: Maddalena Chermetz, DDS MSc
role: Principal Investigator
affiliation: Institute for maternal and child health Burlo Garofolo
last name: Milena Cadenaro, DDS MSc PhD
role: Study Director
affiliation: Institute for maternal and child health Burlo Garofolo
last name: Chiara Navarra, DDS MSc PhD
role: Principal Investigator
affiliation: Institute for maternal and child health Burlo Garofolo
last name: Milena Cadenaro, DDS MSc PhD
phone: +390403785675
email: milena.cadenaro@burlo.trieste.it
last name: Chiara Navarra, DDS MSc PhD
phone: +390403785675
email: chiara.navarra@burlo.trieste.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor
sharing ipd: No