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Breastfeeding Improvement Following Tongue-tie and Lip-tie Release

Primary Purpose

Ankyloglossia, Breastfeeding

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lingual Frenotomy and/or maxillary labial frenectomy
Sponsored by
The Oregon Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankyloglossia

Eligibility Criteria

1 Day - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy babies who are breastfeeding 0-12 weeks of age

Exclusion Criteria:

  • Serious comorbid conditions (heart, lung, brain)
  • Prior maternal breast surgery
  • Insufficient glandular tissue
  • Previous tongue/lip surgery
  • Twins/Triplets

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Intervention

    Arm Description

    All patients were in the same arm - this is a cohort study where the group serves as their own control. Patients who did not undergo the procedure were not included in this outcomes study.

    Outcomes

    Primary Outcome Measures

    Nipple Pain
    Using a visual analog scale, nipple pain is evaluated.
    Reflux/GERD
    Using a validated questionnaire (i-GERQ-R)
    Breastfeeding efficiency
    Volume of breastmilk ingested in a specific time frame calculated (mL/min)
    Breastfeeding self-efficacy
    Uses the BSES-SF validated questionnaire

    Secondary Outcome Measures

    Nipple Pain
    Using a visual analog scale, nipple pain is evaluated.
    Reflux/GERD
    Using a validated questionnaire (i-GERQ-R)
    Breastfeeding self-efficacy
    Uses the BSES-SF validated questionnaire

    Full Information

    First Posted
    December 22, 2015
    Last Updated
    December 29, 2015
    Sponsor
    The Oregon Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02642133
    Brief Title
    Breastfeeding Improvement Following Tongue-tie and Lip-tie Release
    Official Title
    Breastfeeding Improvement Following Tongue-tie and Lip-tie Release: A Prospective Cohort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Oregon Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is an observational study to determine outcomes of surgical release of tongue-tie and lip-tie in babies who are experiencing difficulty with breastfeeding.
    Detailed Description
    Breastfeeding rates in the United States initiate at around 80%, but many mothers are unable to effectively breastfeeding because of problems with latch and suction generation. Previous studies have demonstrated how nipple pain is directly linked to ankyloglossia, but most of these studies are done with poor methodology. Clinically, tongue-tie and lip-tie have correlate with numerous other symptoms besides nipple pain. These babies tend to be inefficient nursers, which can affect weight gain. Abnormal intake of air because of the poor latch/seal can lead to reflux symptoms. Finally, there is a significant psychological toll on mothers who want to breastfeed but cannot do so. This study aims to prospectively analyze these outcomes by using validated tools.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankyloglossia, Breastfeeding

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    237 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Other
    Arm Description
    All patients were in the same arm - this is a cohort study where the group serves as their own control. Patients who did not undergo the procedure were not included in this outcomes study.
    Intervention Type
    Procedure
    Intervention Name(s)
    Lingual Frenotomy and/or maxillary labial frenectomy
    Intervention Description
    The procedure is performed with a 1064nm InGaAsP semiconductor diode laser which is a soft tissue laser with variable pulsed wave and wattage settings. The procedure was performed at 0.7-0.8 pulsed watts, 200 microseconds on and 100 microseconds off (actual wattage: 0.47 to 0.53 W) using a 300 micron laser fiber. The tongue is elevated using a grooved director while the laser tip is applied to the frenulum. If present, the anterior frenulum is divided until the submucosal portion of the tie is identified (this is the posterior tongue-tie). A small window in the central mucosa is made and the lateral mucosal walls of the posterior tongue-tie are released, taking care to not disturb the fascia of the underlying genioglossus muscle.
    Primary Outcome Measure Information:
    Title
    Nipple Pain
    Description
    Using a visual analog scale, nipple pain is evaluated.
    Time Frame
    1 week
    Title
    Reflux/GERD
    Description
    Using a validated questionnaire (i-GERQ-R)
    Time Frame
    1 week
    Title
    Breastfeeding efficiency
    Description
    Volume of breastmilk ingested in a specific time frame calculated (mL/min)
    Time Frame
    1 week
    Title
    Breastfeeding self-efficacy
    Description
    Uses the BSES-SF validated questionnaire
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    Nipple Pain
    Description
    Using a visual analog scale, nipple pain is evaluated.
    Time Frame
    1 month
    Title
    Reflux/GERD
    Description
    Using a validated questionnaire (i-GERQ-R)
    Time Frame
    1 month
    Title
    Breastfeeding self-efficacy
    Description
    Uses the BSES-SF validated questionnaire
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    12 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy babies who are breastfeeding 0-12 weeks of age Exclusion Criteria: Serious comorbid conditions (heart, lung, brain) Prior maternal breast surgery Insufficient glandular tissue Previous tongue/lip surgery Twins/Triplets
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bobak A Ghaheri, MD
    Organizational Affiliation
    The Oregon Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23523198
    Citation
    O'Callahan C, Macary S, Clemente S. The effects of office-based frenotomy for anterior and posterior ankyloglossia on breastfeeding. Int J Pediatr Otorhinolaryngol. 2013 May;77(5):827-32. doi: 10.1016/j.ijporl.2013.02.022. Epub 2013 Mar 22.
    Results Reference
    background
    PubMed Identifier
    18573859
    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.
    Results Reference
    background
    PubMed Identifier
    26255605
    Citation
    Pransky SM, Lago D, Hong P. Breastfeeding difficulties and oral cavity anomalies: The influence of posterior ankyloglossia and upper-lip ties. Int J Pediatr Otorhinolaryngol. 2015 Oct;79(10):1714-7. doi: 10.1016/j.ijporl.2015.07.033. Epub 2015 Jul 31.
    Results Reference
    background
    PubMed Identifier
    27641715
    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.
    Results Reference
    derived

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    Breastfeeding Improvement Following Tongue-tie and Lip-tie Release

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