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
About this trial
This is an interventional treatment trial for Ankyloglossia focused on measuring ankyloglossia, breastfeeding, lip tie
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
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
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
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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
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Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study
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