Ankyloglossia, Feeding, Bottle, Feeding Disorder of Infancy and Childhood
Conditions
Keywords
tongue tie, ankyloglossia, infant feeding, bottle feeding
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.
Interventions
PROCEDURELingual frenotomy
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.
Sponsors
The Oregon Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 12 Weeks
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed