The Impact of Lingual Frenotomy on Bottle Feeding Mechanics

Not Applicable

Completed

• Conditions: Feeding, Bottle; Ankyloglossia; Feeding Disorder of Infancy and Childhood
• Interventions: Procedure: Lingual frenotomy

• Registration Number: NCT03793413
• Lead Sponsor: The Oregon Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-29
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-04
• Study Start: 2019-08-01
• Primary Completion: 2020-08-01
• Study Completion: 2021-07-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-12
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical group	Lingual frenotomy	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Measurement of infant reflux	10 days	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.
Measurement of feeding efficiency	10 days	Feeding efficiency can be measured (volume of intake over measured time)

Trial Locations

Locations (1)

The Oregon Clinic; 🇺🇸 Portland, Oregon, United States