Breastfeeding Improvement Following Tongue-tie and Lip-tie Release

Study Overview
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Brief Summary
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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
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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.

Official Title
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Breastfeeding Improvement Following Tongue-tie and Lip-tie Release: A Prospective Cohort Study

Conditions
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Ankyloglossia, Breastfeeding

Intervention / Treatment
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* Procedure: Lingual Frenotomy and/or maxillary labial frenectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>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. | Procedure: Lingual Frenotomy and/or maxillary labial frenectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nipple Pain | Using a visual analog scale, nipple pain is evaluated. | 1 week | 
| Reflux/GERD | Using a validated questionnaire (i-GERQ-R) | 1 week | 
| Breastfeeding efficiency | Volume of breastmilk ingested in a specific time frame calculated (mL/min) | 1 week | 
| Breastfeeding self-efficacy | Uses the BSES-SF validated questionnaire | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nipple Pain | Using a visual analog scale, nipple pain is evaluated. | 1 month | 
| Reflux/GERD | Using a validated questionnaire (i-GERQ-R) | 1 month | 
| Breastfeeding self-efficacy | Uses the BSES-SF validated questionnaire | 1 month |