NCT03793413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

December 29, 2018

Last Update Submit

September 12, 2021

Conditions

AnkyloglossiaFeeding, BottleFeeding Disorder of Infancy and Childhood

Keywords

tongue tieankyloglossiainfant feedingbottle feeding

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Measurement of infant reflux

    10 days

  • Measurement of feeding efficiency

    10 days

Study Arms (2)

Surgical group

EXPERIMENTAL
Procedure: Lingual frenotomy

Observation group

NO INTERVENTION

Interventions

Lingual frenotomyPROCEDURE

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.

Surgical group

Eligibility Criteria

Age3 Weeks - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Babies who are already fully or partially bottlefeeding
  • Have already worked with lactation consultant prior to appointment
  • Diagnosis of tongue tie

You may not qualify if:

  • Severe neurologic/cardiac/pulmonary comorbid diseases
  • Twins/Triplets
  • Other oral pathology (ie cleft lip/palate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Oregon Clinic

Portland, Oregon, 97220, United States

Location

Related Publications (7)

  • 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.

    PMID: 18573859RESULT

  • 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.

    PMID: 27641715RESULT

  • 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.

    PMID: 29787680RESULT

  • 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.

    PMID: 24706845RESULT

  • 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.

    PMID: 28324904RESULT

  • 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.

    PMID: 24956503RESULT

  • 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.

    PMID: 28008218RESULT

MeSH Terms

Conditions

AnkyloglossiaBottle Feeding

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesFeeding BehaviorBehavior

Study Officials

  • Bobak Ghaheri, MD

    The Oregon Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Otolaryngologist

Study Record Dates

First Submitted

December 29, 2018

First Posted

January 4, 2019

Study Start

August 1, 2019

Primary Completion

August 1, 2020

Study Completion

July 27, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)