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The Impact of Lingual Frenotomy on Bottle Feeding Mechanics

Primary Purpose

Ankyloglossia, Feeding, Bottle, Feeding Disorder of Infancy and Childhood

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lingual frenotomy
Sponsored by
The Oregon Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankyloglossia focused on measuring tongue tie, ankyloglossia, infant feeding, bottle feeding

Eligibility Criteria

3 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • The Oregon Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical group

Observation group

Arm Description

Outcomes

Primary Outcome Measures

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)
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.
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.
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.

Secondary Outcome Measures

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.
Measurement of feeding efficiency
Feeding efficiency can be measured (volume of intake over measured time)

Full Information

First Posted
December 29, 2018
Last Updated
September 12, 2021
Sponsor
The Oregon Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03793413
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
July 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Oregon Clinic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankyloglossia, Feeding, Bottle, Feeding Disorder of Infancy and Childhood
Keywords
tongue tie, ankyloglossia, infant feeding, bottle feeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical group
Arm Type
Experimental
Arm Title
Observation group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Lingual frenotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improved sucking parameter on the NFANT bottle feeding system - amplitude
Description
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
Title
Improved sucking parameter on the NFANT bottle feeding system - sucking frequency
Description
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
Title
Improved sucking parameter on the NFANT bottle feeding system - sucking duration
Description
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
Title
Improved sucking parameter on the NFANT bottle feeding system - sucking smoothness
Description
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
Secondary Outcome Measure Information:
Title
Measurement of infant reflux
Description
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
Title
Measurement of feeding efficiency
Description
Feeding efficiency can be measured (volume of intake over measured time)
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bobak Ghaheri, MD
Organizational Affiliation
The Oregon Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18573859
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.
Results Reference
result
PubMed Identifier
27641715
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.
Results Reference
result
PubMed Identifier
29787680
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.
Results Reference
result
PubMed Identifier
24706845
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.
Results Reference
result
PubMed Identifier
28324904
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.
Results Reference
result
PubMed Identifier
24956503
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.
Results Reference
result
PubMed Identifier
28008218
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.
Results Reference
result

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The Impact of Lingual Frenotomy on Bottle Feeding Mechanics

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