The Impact of Lingual Frenotomy on Bottle Feeding Mechanics

Ankyloglossia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793413
• Other study ID #: Ghaheri 3
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: July 27, 2021

Study information

• Verified date: September 2021
• Source: The Oregon Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 27, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Ankyloglossia
• Feeding and Eating Disorders
• Feeding Disorder of Infancy and Childhood
• Feeding, Bottle

Intervention

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.

Locations

Country	Name	City	State
United States	The Oregon Clinic	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
The Oregon Clinic

Country where clinical trial is conducted

United States, 

References & Publications (7)

Capilouto GJ, Cunningham T, Frederick E, Dupont-Versteegden E, Desai N, Butterfield TA. Comparison of tongue muscle characteristics of preterm and full term infants during nutritive and nonnutritive sucking. Infant Behav Dev. 2014 Aug;37(3):435-45. doi: 1 — View Citation

Capilouto GJ, Cunningham TJ, Mullineaux DR, Tamilia E, Papadelis C, Giannone PJ. Quantifying Neonatal Sucking Performance: Promise of New Methods. Semin Speech Lang. 2017 Apr;38(2):147-158. doi: 10.1055/s-0037-1599112. Epub 2017 Mar 21. — View Citation

Capilouto GJ, Cunningham TJ. Objective assessment of a preterm infant's nutritive sucking from initiation of feeding through hospitalization and discharge. Neonatal Intensive Care. 2016 Winter;29(1):40-45. — View Citation

Elad D, Kozlovsky P, Blum O, Laine AF, Po MJ, Botzer E, Dollberg S, Zelicovich M, Ben Sira L. Biomechanics of milk extraction during breast-feeding. Proc Natl Acad Sci U S A. 2014 Apr 8;111(14):5230-5. doi: 10.1073/pnas.1319798111. Epub 2014 Mar 24. — View Citation

Geddes DT, Langton DB, Gollow I, Jacobs LA, Hartmann PE, Simmer K. Frenulotomy for breastfeeding infants with ankyloglossia: effect on milk removal and sucking mechanism as imaged by ultrasound. Pediatrics. 2008 Jul;122(1):e188-94. doi: 10.1542/peds.2007- — View Citation

Ghaheri BA, Cole M, Fausel SC, Chuop M, Mace JC. Breastfeeding improvement following tongue-tie and lip-tie release: A prospective cohort study. Laryngoscope. 2017 May;127(5):1217-1223. doi: 10.1002/lary.26306. Epub 2016 Sep 19. — View Citation

Ghaheri BA, Cole M, Mace JC. Revision Lingual Frenotomy Improves Patient-Reported Breastfeeding Outcomes: A Prospective Cohort Study. J Hum Lact. 2018 Aug;34(3):566-574. doi: 10.1177/0890334418775624. Epub 2018 May 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Measurement of feeding efficiency	Feeding efficiency can be measured (volume of intake over measured time)	10 days