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
About this trial
This is an interventional treatment trial for Ankyloglossia
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
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
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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