The Impact of Lingual Frenotomy on Bottle Feeding Mechanics

The Oregon Clinic

Status: Completed

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

Treatments: Procedure: Lingual frenotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03793413

Ghaheri 3

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 3 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

47 participants in 2 patient groups

Surgical group

Experimental group

Treatment:

Procedure: Lingual frenotomy

Observation group

No Intervention group