- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02642133
Breastfeeding Improvement Following Tongue-tie and Lip-tie Release
Breastfeeding Improvement Following Tongue-tie and Lip-tie Release: A Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nipple Pain
Time Frame: 1 week
|
Using a visual analog scale, nipple pain is evaluated.
|
1 week
|
Reflux/GERD
Time Frame: 1 week
|
Using a validated questionnaire (i-GERQ-R)
|
1 week
|
Breastfeeding efficiency
Time Frame: 1 week
|
Volume of breastmilk ingested in a specific time frame calculated (mL/min)
|
1 week
|
Breastfeeding self-efficacy
Time Frame: 1 week
|
Uses the BSES-SF validated questionnaire
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nipple Pain
Time Frame: 1 month
|
Using a visual analog scale, nipple pain is evaluated.
|
1 month
|
Reflux/GERD
Time Frame: 1 month
|
Using a validated questionnaire (i-GERQ-R)
|
1 month
|
Breastfeeding self-efficacy
Time Frame: 1 month
|
Uses the BSES-SF validated questionnaire
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bobak A Ghaheri, MD, The Oregon Clinic
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TOC ENT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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