Clinical trial NCT03793413: The Impact of Lingual Frenotomy on Bottle Feeding Mechanics
Official title: The Impact of Lingual Frenotomy on Bottle Feeding Mechanics: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankyloglossia
Feeding, Bottle
Feeding Disorder of Infancy and Childhood
Keywords: tongue tie
ankyloglossia
infant feeding
bottle feeding
Lead sponsor: The Oregon Clinic
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 47
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Improved sucking parameter on the NFANT bottle feeding system - amplitude
timeFrame: 10 days
measure: Improved sucking parameter on the NFANT bottle feeding system - sucking frequency
timeFrame: 10 days
measure: Improved sucking parameter on the NFANT bottle feeding system - sucking duration
timeFrame: 10 days
measure: Improved sucking parameter on the NFANT bottle feeding system - sucking smoothness
timeFrame: 10 days
Secondary outcomes:
measure: Measurement of infant reflux
timeFrame: 10 days
measure: Measurement of feeding efficiency
timeFrame: 10 days
Other outcomes:
Locations:
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
Study officials:
affiliation: The Oregon Clinic
name: Bobak Ghaheri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.2007-2553. Epub 2008 Jun 23.
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.
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.
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.
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.
citation: 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: 10.1016/j.infbeh.2014.05.010. Epub 2014 Jun 20.
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.