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NCT Number: NCT03793413

The Impact of Lingual Frenotomy on Bottle Feeding Mechanics

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.

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Key information

Conditions

Ankyloglossia Behavior Bottle Feeding Feeding Behavior Feeding Disorder of Infancy and Childhood Feeding, Bottle Stomatognathic Diseases

Age range

3 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Oregon Clinic

Portland, Oregon, 97220, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lingual frenotomy

Procedure

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 outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. Measurement of feeding efficiency

    Time frame: 10 days

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

Sponsors and collaborators

Lead sponsor

The Oregon Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 4, 2019
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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