<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/NCT03793413</url>
  </required_header>
  <id_info>
    <org_study_id>Ghaheri 3</org_study_id>
    <nct_id>NCT03793413</nct_id>
  </id_info>
  <brief_title>The Impact of Lingual Frenotomy on Bottle Feeding Mechanics</brief_title>
  <official_title>The Impact of Lingual Frenotomy on Bottle Feeding Mechanics: a Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Oregon Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Oregon Clinic</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>
      Conservative estimates show that 3-5% of all infants have tongue tie. These studies only&#xD;
      focus on visible, anterior tongue tie. Deeper, more visibly subtle cases of ankyloglossia&#xD;
      have not been included in these incidence numbers, so the percentage of children with&#xD;
      ankyloglossia is much higher than previously thought. Previous research by the investigators&#xD;
      demonstrates that posterior tongue tie can be as problematic as anterior ties.&#xD;
&#xD;
      An available FDA-approved feeding solution allows for the measurement of infant sucking&#xD;
      motions. This allows for detection of changes following surgical intervention. Previous&#xD;
      ultrasound studies show the importance of the upward movement of the tongue, but further&#xD;
      lingual movement parameters following frenotomy have not been reported.&#xD;
&#xD;
      The primary goal of this study is to record changes in lingual movement following lingual&#xD;
      frenotomy. The investigators plan to compare improvements over time between a control,&#xD;
      non-intervention group and a frenotomy group. Secondary goals include recording validated&#xD;
      outcomes of reflux and feeding efficiency.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Actual">July 27, 2021</completion_date>
  <primary_completion_date type="Actual">August 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improved sucking parameter on the NFANT bottle feeding system - amplitude</measure>
    <time_frame>10 days</time_frame>
    <description>The NFANT bottle feeding system automatically generates measurements of sucking parameters. The first sucking parameter to be measured is calibrated nipple movement (amplitude)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improved sucking parameter on the NFANT bottle feeding system - sucking frequency</measure>
    <time_frame>10 days</time_frame>
    <description>The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking frequency.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improved sucking parameter on the NFANT bottle feeding system - sucking duration</measure>
    <time_frame>10 days</time_frame>
    <description>The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking duration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improved sucking parameter on the NFANT bottle feeding system - sucking smoothness</measure>
    <time_frame>10 days</time_frame>
    <description>The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking smoothness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of infant reflux</measure>
    <time_frame>10 days</time_frame>
    <description>Use of a validated survey (the infant gastroesophageal reflux questionnaire revised or I-GERQ-R questionnaire). The I-GERQ-R utilizes ordinal response scales to measure the severity of symptoms associated with infant gas- troesophageal reflux disease (GERD). Scoring involves the sum- marization of 12 items (score range, 0-42), where lower scores reflect lower symptom severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of feeding efficiency</measure>
    <time_frame>10 days</time_frame>
    <description>Feeding efficiency can be measured (volume of intake over measured time)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Ankyloglossia</condition>
  <condition>Feeding, Bottle</condition>
  <condition>Feeding Disorder of Infancy and Childhood</condition>
  <arm_group>
    <arm_group_label>Surgical group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lingual frenotomy</intervention_name>
    <description>A lingual frenotomy will be performed using a CO2 laser - using the NFANT bottle feeding system, the intervention arm will be compared against the observation arm to determine if there are changes in lingual mobility parameters during bottle feeding.</description>
    <arm_group_label>Surgical group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Babies who are already fully or partially bottlefeeding&#xD;
&#xD;
          -  Have already worked with lactation consultant prior to appointment&#xD;
&#xD;
          -  Diagnosis of tongue tie&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe neurologic/cardiac/pulmonary comorbid diseases&#xD;
&#xD;
          -  Twins/Triplets&#xD;
&#xD;
          -  Other oral pathology (ie cleft lip/palate)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Weeks</minimum_age>
    <maximum_age>12 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bobak Ghaheri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Oregon Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Oregon Clinic</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Geddes DT, Langton DB, Gollow I, Jacobs LA, Hartmann PE, Simmer K. Frenulotomy for breastfeeding infants with ankyloglossia: effect on milk removal and sucking mechanism as imaged by ultrasound. Pediatrics. 2008 Jul;122(1):e188-94. doi: 10.1542/peds.2007-2553. Epub 2008 Jun 23.</citation>
    <PMID>18573859</PMID>
  </results_reference>
  <results_reference>
    <citation>Ghaheri BA, Cole M, Fausel SC, Chuop M, Mace JC. Breastfeeding improvement following tongue-tie and lip-tie release: A prospective cohort study. Laryngoscope. 2017 May;127(5):1217-1223. doi: 10.1002/lary.26306. Epub 2016 Sep 19.</citation>
    <PMID>27641715</PMID>
  </results_reference>
  <results_reference>
    <citation>Ghaheri BA, Cole M, Mace JC. Revision Lingual Frenotomy Improves Patient-Reported Breastfeeding Outcomes: A Prospective Cohort Study. J Hum Lact. 2018 Aug;34(3):566-574. doi: 10.1177/0890334418775624. Epub 2018 May 22.</citation>
    <PMID>29787680</PMID>
  </results_reference>
  <results_reference>
    <citation>Elad D, Kozlovsky P, Blum O, Laine AF, Po MJ, Botzer E, Dollberg S, Zelicovich M, Ben Sira L. Biomechanics of milk extraction during breast-feeding. Proc Natl Acad Sci U S A. 2014 Apr 8;111(14):5230-5. doi: 10.1073/pnas.1319798111. Epub 2014 Mar 24.</citation>
    <PMID>24706845</PMID>
  </results_reference>
  <results_reference>
    <citation>Capilouto GJ, Cunningham TJ, Mullineaux DR, Tamilia E, Papadelis C, Giannone PJ. Quantifying Neonatal Sucking Performance: Promise of New Methods. Semin Speech Lang. 2017 Apr;38(2):147-158. doi: 10.1055/s-0037-1599112. Epub 2017 Mar 21.</citation>
    <PMID>28324904</PMID>
  </results_reference>
  <results_reference>
    <citation>Capilouto GJ, Cunningham T, Frederick E, Dupont-Versteegden E, Desai N, Butterfield TA. Comparison of tongue muscle characteristics of preterm and full term infants during nutritive and nonnutritive sucking. Infant Behav Dev. 2014 Aug;37(3):435-45. doi: 10.1016/j.infbeh.2014.05.010. Epub 2014 Jun 20.</citation>
    <PMID>24956503</PMID>
  </results_reference>
  <results_reference>
    <citation>Capilouto GJ, Cunningham TJ. Objective assessment of a preterm infant's nutritive sucking from initiation of feeding through hospitalization and discharge. Neonatal Intensive Care. 2016 Winter;29(1):40-45.</citation>
    <PMID>28008218</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>September 12, 2021</last_update_submitted>
  <last_update_submitted_qc>September 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Oregon Clinic</investigator_affiliation>
    <investigator_full_name>Bobak Ghaheri, MD</investigator_full_name>
    <investigator_title>Otolaryngologist</investigator_title>
  </responsible_party>
  <keyword>tongue tie</keyword>
  <keyword>ankyloglossia</keyword>
  <keyword>infant feeding</keyword>
  <keyword>bottle feeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ankyloglossia</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
  </condition_browse>
  <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/NCT03793413
org study id: Ghaheri 3
nct id: NCT03793413
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Conservative estimates show that 3-5% of all infants have tongue tie. These studies only
      focus on visible, anterior tongue tie. Deeper, more visibly subtle cases of ankyloglossia
      have not been included in these incidence numbers, so the percentage of children with
      ankyloglossia is much higher than previously thought. Previous research by the investigators
      demonstrates that posterior tongue tie can be as problematic as anterior ties.

      An available FDA-approved feeding solution allows for the measurement of infant sucking
      motions. This allows for detection of changes following surgical intervention. Previous
      ultrasound studies show the importance of the upward movement of the tongue, but further
      lingual movement parameters following frenotomy have not been reported.

      The primary goal of this study is to record changes in lingual movement following lingual
      frenotomy. The investigators plan to compare improvements over time between a control,
      non-intervention group and a frenotomy group. Secondary goals include recording validated
      outcomes of reflux and feeding efficiency.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improved sucking parameter on the NFANT bottle feeding system - amplitude
time frame: 10 days
description: The NFANT bottle feeding system automatically generates measurements of sucking parameters. The first sucking parameter to be measured is calibrated nipple movement (amplitude)
measure: Improved sucking parameter on the NFANT bottle feeding system - sucking frequency
time frame: 10 days
description: The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking frequency.
measure: Improved sucking parameter on the NFANT bottle feeding system - sucking duration
time frame: 10 days
description: The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking duration.
measure: Improved sucking parameter on the NFANT bottle feeding system - sucking smoothness
time frame: 10 days
description: The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking smoothness.
measure: Measurement of infant reflux
time frame: 10 days
description: Use of a validated survey (the infant gastroesophageal reflux questionnaire revised or I-GERQ-R questionnaire). The I-GERQ-R utilizes ordinal response scales to measure the severity of symptoms associated with infant gas- troesophageal reflux disease (GERD). Scoring involves the sum- marization of 12 items (score range, 0-42), where lower scores reflect lower symptom severity.
measure: Measurement of feeding efficiency
time frame: 10 days
description: Feeding efficiency can be measured (volume of intake over measured time)
arm group label: Surgical group
arm group type: Experimental
arm group label: Observation group
arm group type: No Intervention
intervention type: Procedure
intervention name: Lingual frenotomy
description: A lingual frenotomy will be performed using a CO2 laser - using the NFANT bottle feeding system, the intervention arm will be compared against the observation arm to determine if there are changes in lingual mobility parameters during bottle feeding.
arm group label: Surgical group
criteria: 
gender: All
minimum age: 3 Weeks
maximum age: 12 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Bobak Ghaheri, MD
role: Principal Investigator
affiliation: The Oregon Clinic
facility: 
country: United States
citation: Geddes DT, Langton DB, Gollow I, Jacobs LA, Hartmann PE, Simmer K. Frenulotomy for breastfeeding infants with ankyloglossia: effect on milk removal and sucking mechanism as imaged by ultrasound. Pediatrics. 2008 Jul;122(1):e188-94. doi: 10.1542/peds.2007-2553. Epub 2008 Jun 23.
PMID: 18573859
citation: Ghaheri BA, Cole M, Fausel SC, Chuop M, Mace JC. Breastfeeding improvement following tongue-tie and lip-tie release: A prospective cohort study. Laryngoscope. 2017 May;127(5):1217-1223. doi: 10.1002/lary.26306. Epub 2016 Sep 19.
PMID: 27641715
citation: Ghaheri BA, Cole M, Mace JC. Revision Lingual Frenotomy Improves Patient-Reported Breastfeeding Outcomes: A Prospective Cohort Study. J Hum Lact. 2018 Aug;34(3):566-574. doi: 10.1177/0890334418775624. Epub 2018 May 22.
PMID: 29787680
citation: Elad D, Kozlovsky P, Blum O, Laine AF, Po MJ, Botzer E, Dollberg S, Zelicovich M, Ben Sira L. Biomechanics of milk extraction during breast-feeding. Proc Natl Acad Sci U S A. 2014 Apr 8;111(14):5230-5. doi: 10.1073/pnas.1319798111. Epub 2014 Mar 24.
PMID: 24706845
citation: Capilouto GJ, Cunningham TJ, Mullineaux DR, Tamilia E, Papadelis C, Giannone PJ. Quantifying Neonatal Sucking Performance: Promise of New Methods. Semin Speech Lang. 2017 Apr;38(2):147-158. doi: 10.1055/s-0037-1599112. Epub 2017 Mar 21.
PMID: 28324904
citation: Capilouto GJ, Cunningham T, Frederick E, Dupont-Versteegden E, Desai N, Butterfield TA. Comparison of tongue muscle characteristics of preterm and full term infants during nutritive and nonnutritive sucking. Infant Behav Dev. 2014 Aug;37(3):435-45. doi: 10.1016/j.infbeh.2014.05.010. Epub 2014 Jun 20.
PMID: 24956503
citation: Capilouto GJ, Cunningham TJ. Objective assessment of a preterm infant's nutritive sucking from initiation of feeding through hospitalization and discharge. Neonatal Intensive Care. 2016 Winter;29(1):40-45.
PMID: 28008218
responsible party type: Principal Investigator
investigator affiliation: The Oregon Clinic
investigator full name: Bobak Ghaheri, MD
investigator title: Otolaryngologist
mesh term: Ankyloglossia
mesh term: Feeding and Eating Disorders
sharing ipd: No