An interventional study of Lingual frenotomy in Ankyloglossia, Feeding, Bottle and Feeding Disorder of Infancy and Childhood, sponsored by The Oregon Clinic. Completed at 1 site in United States. Open to participants aged 3 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-14.
Sponsored by The Oregon Clinic · Not applicable, Interventional, and Treatment
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.
32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.
This study's enrollment of 47 is below the median of 105 across 22 interventional studies indexed under Ankyloglossia.
Browse Ankyloglossia studies →The Oregon Clinic is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Procedure: Lingual 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.
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 days
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.
Time frame: 10 days
Measurement of feeding efficiency
Feeding efficiency can be measured (volume of intake over measured time)
Time frame: 10 days
Plan to share: No
Ran from Aug 2019 to primary completion in Aug 2020, 12 months.
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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