The Impact of Lingual Frenotomy on Bottle Feeding Mechanics

September 12, 2021 updated by: Bobak Ghaheri, MD, The Oregon Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97220
        • The Oregon Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 weeks to 2 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Surgical group
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.
NO_INTERVENTION: Observation group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved sucking parameter on the NFANT bottle feeding system - amplitude
Time Frame: 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)
10 days
Improved sucking parameter on the NFANT bottle feeding system - sucking frequency
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking smoothness.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of infant reflux
Time Frame: 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.
10 days
Measurement of feeding efficiency
Time Frame: 10 days
Feeding efficiency can be measured (volume of intake over measured time)
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Oregon Clinic

Investigators

  • Principal Investigator: Bobak Ghaheri, MD, The Oregon Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ACTUAL)

August 1, 2020

Study Completion (ACTUAL)

July 27, 2021

Study Registration Dates

First Submitted

December 29, 2018

First Submitted That Met QC Criteria

January 3, 2019

First Posted (ACTUAL)

January 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 12, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ghaheri 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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