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Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study

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 focused on measuring ankyloglossia, breastfeeding, lip tie

Eligibility Criteria

1 Day - 8 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy babies who are breastfeeding
  • Had a previous frenotomy prior to presenting to the P.I.

Exclusion Criteria:

  • Twins, triplets
  • Maternal breast surgery or IGT
  • Premature birth
  • Significant heart/lung/brain disease of infant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    Nipple pain
    Reflux (i-GERQ-R)
    Maternal breastfeeding self-efficacy (BSES-SF)

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2016
    Last Updated
    September 19, 2017
    Sponsor
    The Oregon Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02936518
    Brief Title
    Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study
    Official Title
    Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    A previously published study (https://www.ncbi.nlm.nih.gov/pubmed/27641715) identified breastfeeding improvements following lingual frenotomy and/or maxillary labial frenectomy. In the previous cohort, babies were excluded from the study if they had previously undergone an attempted frenotomy prior to seeing the P.I. in the office. The proposed study will only look at those babies who did undergo a previous frenotomy to determine: the presence of continued problematic breastfeeding symptoms if further tongue tie or lip tie release improves those outcomes

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankyloglossia, Breastfeeding
    Keywords
    ankyloglossia, breastfeeding, lip tie

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Lingual frenotomy and/or maxillary labial frenectomy
    Primary Outcome Measure Information:
    Title
    Nipple pain
    Time Frame
    1 week post-procedure
    Title
    Reflux (i-GERQ-R)
    Time Frame
    1 week and 1 month post-procedure
    Title
    Maternal breastfeeding self-efficacy (BSES-SF)
    Time Frame
    1 week and 1 month post-procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    8 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy babies who are breastfeeding Had a previous frenotomy prior to presenting to the P.I. Exclusion Criteria: Twins, triplets Maternal breast surgery or IGT Premature birth Significant heart/lung/brain disease of infant

    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
    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
    background

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    Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study

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