The Impact of Lingual Frenotomy on Bottle Feeding Mechanics

Study Overview
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Brief Summary
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Conservative estimates show that 3-5% of all infants have tongue tie. These studies only focus on visible, anterior tongue tie. Deeper, more visibly subtle cases of ankyloglossia have not been included in these incidence numbers, so the percentage of children with ankyloglossia is much higher than previously thought. Previous research by the investigators demonstrates that posterior tongue tie can be as problematic as anterior ties. An available FDA-approved feeding solution allows for the measurement of infant sucking motions. This allows for detection of changes following surgical intervention. Previous ultrasound studies show the importance of the upward movement of the tongue, but further lingual movement parameters following frenotomy have not been reported. The primary goal of this study is to record changes in lingual movement following lingual frenotomy. The investigators plan to compare improvements over time between a control, non-intervention group and a frenotomy group. Secondary goals include recording validated outcomes of reflux and feeding efficiency.

Official Title
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The Impact of Lingual Frenotomy on Bottle Feeding Mechanics: a Randomized, Controlled Trial

Conditions
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Ankyloglossia, Feeding, Bottle, Feeding Disorder of Infancy and Childhood

Intervention / Treatment
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* Procedure: Lingual frenotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Babies who are already fully or partially bottlefeeding Have already worked with lactation consultant prior to appointment Diagnosis of tongue tie Exclusion Criteria: Severe neurologic/cardiac/pulmonary comorbid diseases Twins/Triplets Other oral pathology (ie cleft lip/palate)

Ages Eligible for Study
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Minimum Age: 3 Weeks
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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical group<br> | Procedure: Lingual frenotomy<br>* A lingual frenotomy will be performed using a CO2 laser - using the NFANT bottle feeding system, the intervention arm will be compared against the observation arm to determine if there are changes in lingual mobility parameters during bottle feeding.<br>|
| No Intervention: Observation group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved sucking parameter on the NFANT bottle feeding system - amplitude | The NFANT bottle feeding system automatically generates measurements of sucking parameters. The first sucking parameter to be measured is calibrated nipple movement (amplitude) | 10 days | 
| Improved sucking parameter on the NFANT bottle feeding system - sucking frequency | The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking frequency. | 10 days | 
| Improved sucking parameter on the NFANT bottle feeding system - sucking duration | The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking duration. | 10 days | 
| Improved sucking parameter on the NFANT bottle feeding system - sucking smoothness | The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking smoothness. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of infant reflux | Use of a validated survey (the infant gastroesophageal reflux questionnaire revised or I-GERQ-R questionnaire). The I-GERQ-R utilizes ordinal response scales to measure the severity of symptoms associated with infant gas- troesophageal reflux disease (GERD). Scoring involves the sum- marization of 12 items (score range, 0-42), where lower scores reflect lower symptom severity. | 10 days | 
| Measurement of feeding efficiency | Feeding efficiency can be measured (volume of intake over measured time) | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tongue tie, ankyloglossia, infant feeding, bottle feeding