AnkyloglossiaNCT03793413
The Impact of Lingual Frenotomy on Bottle Feeding Mechanics
A study testing Lingual frenotomy in people with Ankyloglossia and Feeding, Bottle, run by The Oregon Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Ankyloglossia, Feeding, Bottle, Feeding Disorder of Infancy and Childhood
- What is being tested?
- Lingual frenotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 27 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Babies who are already fully or partially bottlefeeding
- Have already worked with lactation consultant prior to appointment
- Diagnosis of tongue tie
Who cannot join
- Severe neurologic/cardiac/pulmonary comorbid diseases
- Twins/Triplets
- Other oral pathology (ie cleft lip/palate)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Lingual frenotomy
- Keywords
- tongue tie, ankyloglossia, infant feeding, bottle feeding
- Medical subject headings
- Ankyloglossia, Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual frenotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Experimental | Not described Receives: Procedure: Lingual frenotomy |
| Observation group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 days
Secondary outcomes (2)
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.
Measured: 10 days
Measurement of feeding efficiency
Feeding efficiency can be measured (volume of intake over measured time)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2020
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnkyloglossiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Oregon Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bobak Ghaheri, MD, The Oregon Clinic
- Investigators
- Bobak Ghaheri, MD, Principal investigator, The Oregon Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793413
- Sponsor's protocol ID
- Ghaheri 3
- Status last verified
- Sep 2021
- First submitted
- 29 Dec 2018
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18573859Ghaheri 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.
PubMed 27641715Ghaheri 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.
PubMed 29787680Elad 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.
PubMed 24706845Capilouto 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.
PubMed 28324904Capilouto 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.
PubMed 24956503Capilouto 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.
PubMed 28008218
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lingual Frenotomy on Bottle Feeding Mechanics: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03793413
- Acronym / sponsor ID
- Ghaheri 3
- Keywords
- tongue tie, ankyloglossia, infant feeding, bottle feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- The Oregon ClinicUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical group | Experimental | Procedure: Lingual frenotomy |
| Observation group | No intervention | – |
Who may qualify
- Ages
- 3 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Babies who are already fully or partially bottlefeeding
- Have already worked with lactation consultant prior to appointment
- Diagnosis of tongue tie
Key exclusion criteria (3 listed)
- Severe neurologic/cardiac/pulmonary comorbid diseases
- Twins/Triplets
- Other oral pathology (ie cleft lip/palate)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lingual frenotomyA 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. | Procedure or surgery | Surgical group |
Primary outcome
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)
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.
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.
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.
2 secondary outcomes
Measurement of infant reflux
Time frame: 10 days
Measurement of feeding efficiency
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Results publication: PubMed 18573859Geddes 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 publication: PubMed 27641715Ghaheri 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 publication: PubMed 29787680Ghaheri 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 publication: PubMed 24706845Elad 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 publication: PubMed 28324904Capilouto 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 publication: PubMed 24956503Capilouto 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 publication: PubMed 28008218Capilouto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bobak Ghaheri, MD principal investigator
The Oregon Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lingual frenotomy in people with Ankyloglossia and Feeding, Bottle, run by The Oregon Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved sucking parameter on the NFANT bottle feeding system - amplitude (time frame: 10 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03793413, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.