AnkyloglossiaNCT06830148
Post-Procedural Manual Manipulation for Infant Ankyloglossia
A study testing Post-frenotomy manual manipulation in people with Ankyloglossia and Breastfeeding Support, run by Georgetown University at 1 site in United States.
Trial summary
The goal of this randomized control trial is to determine the impact of post-frenotomy manual manipulation on revision rates and breastfeeding outcomes. We hypothesize that post-frenotomy manipulation will reduce the rate of sublingual frenulum regrowth, and subsequently frenotomy revision rates, thereby improving… Read more about this study
- Who is it for?
- Ages Up to 90 days
- Conditions the study is for
- Ankyloglossia, Breastfeeding Support
- What is being tested?
- Post-frenotomy manual manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants less than 90 days old with ankyloglossia who undergo outpatient frenotomy using cold-steel scissors and will be exclusively or partially breastfed.
Who cannot join
- infants older than 90 days, those who will be exclusively bottle fed, infants who undergo concomitant lip tie release, those who undergo laser frenotomy, and infants who have previously undergone a frenotomy.
- infants with a gestational age of less than 36 weeks, those in the NICU or post-partum unit, infants who didn't receive the vitamin K injection, and those with congenital anomalies or medical conditions affecting breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery
Washington D.C., District of Columbia, 20007
Emily A Clementi, BA, (202) 444-8186, eac166@georgetown.edu
About this study
Official title: Effectiveness of Post-Procedural Manual Manipulation for Infant Ankyloglossia in Enhancing Breastfeeding and Reducing Revision Rates: A Prospective Randomized Trial
The goal of this randomized control trial is to determine the impact of post-frenotomy manual manipulation on revision rates and breastfeeding outcomes. We hypothesize that post-frenotomy manipulation will reduce the rate of sublingual frenulum regrowth, and subsequently frenotomy revision rates, thereby improving breastfeeding performance.
Infants with ankyloglossia undergoing frenotomy will be randomized into two groups: the intervention group (post-frenotomy manipulation) and the control group (no intervention). Parents in the intervention group will be instructed to perform tongue stretching and suck "re-training" exercises four times daily for 2-3 weeks, beginning 24 hours post-procedure. To monitor adherence and assess any complications, investigators will conduct a follow-up phone call one week after the procedure. Parents in the control group will not be instructed to perform any post-procedural manipulation. All participants will have a mandatory in-person follow-up 2-3 weeks postoperatively, during which breastfeeding outcomes and the need for frenotomy revision will be evaluated.
- Conditions
- Ankyloglossia, Breastfeeding Support
- Being tested
- Post-frenotomy manual manipulation
- Keywords
- tongue tie, breastfeeding, exercises, infant, pediatric otolaryngology, frenotomy
- Medical subject headings
- Ankyloglossia, Breast Feeding, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-frenotomy manual manipulationOther
Also called Post-procedural exercises
Parents assigned to the treatment group will be instructed to perform post-frenotomy stretches and exercises four times daily, after every other feed, until the time of their postoperative visit 2-3 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | In the treatment group, parents will be instructed to perform postprocedural manipulation after the frenotomy. Receives: Other: Post-frenotomy manual manipulation |
| Control Group | No intervention | In the control group, parents will not receive any instructions to perform "suck re-training" exercises or stretching following the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of infants who are recommended to undergo repeat frenotomy
Recommendations for frenotomy revision will be made by the principal investigator during the post-operative visit, which occurs 2-3 weeks following the procedure. This will include a physical examination to assess post-operative healing, along with an evaluation of the mother's breastfeeding outcomes.
Measured: From enrollment to the 2-3 week postoperative visit
Improvement in breastfeeding performance following post-procedural manual manipulation
Pre- and post-operative maternal breastfeeding performance will be assessed using the LATCH score, a validated questionnaire that evaluates breastfeeding effectiveness. The pre-operative score will be administered during the initial consultation, while the post-operative score will be taken at the follow-up visit, 2-3 weeks after the procedure. The difference in scores will be analyzed to determine if there is an improvement in maternal breastfeeding outcomes.
Measured: From enrollment to the 2-3 week postoperative visit
Secondary outcomes (1)
Compliance with post-frenotomy stretching and exercises
Parents assigned to the treatment group will receive a phone call one week postoperatively to assess their adherence to the treatment plan.
Measured: From enrollment to the 1 week postoperative phone call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start15 Oct 2024
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Earl H. Harley, Jr., MD, Georgetown University
- Investigators
- Earl H Harley, MD, Principal investigator, MedStar Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830148
- Sponsor's protocol ID
- STUDY00008313
- Status last verified
- Nov 2024
- First submitted
- 11 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
LeFort Y, Evans A, Livingstone V, Douglas P, Dahlquist N, Donnelly B, Leeper K, Harley E, Lappin S. Academy of Breastfeeding Medicine Position Statement on Ankyloglossia in Breastfeeding Dyads. Breastfeed Med. 2021 Apr;16(4):278-281. doi: 10.1089/bfm.2021.29179.ylf. No abstract available.
PubMed 33852342Messner AH, Walsh J, Rosenfeld RM, Schwartz SR, Ishman SL, Baldassari C, Brietzke SE, Darrow DH, Goldstein N, Levi J, Meyer AK, Parikh S, Simons JP, Wohl DL, Lambie E, Satterfield L. Clinical Consensus Statement: Ankyloglossia in Children. Otolaryngol Head Neck Surg. 2020 May;162(5):597-611. doi: 10.1177/0194599820915457. Epub 2020 Apr 14.
PubMed 32283998
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Post-Procedural Manual Manipulation for Infant Ankyloglossia in Enhancing Breastfeeding and Reducing Revision Rates: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06830148
- Acronym / sponsor ID
- STUDY00008313
- Conditions
- Ankyloglossia, Breastfeeding Support
- Keywords
- tongue tie, breastfeeding, exercises, infant, pediatric otolaryngology, frenotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 17 Feb 2025 (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.
The goal of this randomized control trial is to determine the impact of post-frenotomy manual manipulation on revision rates and breastfeeding outcomes. We hypothesize that post-frenotomy manipulation will reduce the rate of sublingual frenulum regrowth, and subsequently frenotomy revision rates, thereby improving breastfeeding performance.
Infants with ankyloglossia undergoing frenotomy will be randomized into two groups: the intervention group (post-frenotomy manipulation) and the control group (no intervention). Parents in the intervention group will be instructed to perform tongue stretching and suck "re-training" exercises four times daily for 2-3 weeks, beginning 24 hours post-procedure. To monitor adherence and assess any complications, investigators will conduct a follow-up phone call one week after the procedure. Parents in the control group will not be instructed to perform any post-procedural manipulation. All participants will have a mandatory in-person follow-up 2-3 weeks postoperatively, during which breastfeeding outcomes and the need for frenotomy revision will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Post-frenotomy manual manipulationIn the treatment group, parents will be instructed to perform postprocedural manipulation after the frenotomy. |
| Control Group | No intervention | –In the control group, parents will not receive any instructions to perform "suck re-training" exercises or stretching following the procedure. |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants less than 90 days old with ankyloglossia who undergo outpatient frenotomy using cold-steel scissors and will be exclusively or partially breastfed.
Key exclusion criteria (2 listed)
- infants older than 90 days, those who will be exclusively bottle fed, infants who undergo concomitant lip tie release, those who undergo laser frenotomy, and infants who have previously undergone a frenotomy.
- infants with a gestational age of less than 36 weeks, those in the NICU or post-partum unit, infants who didn't receive the vitamin K injection, and those with congenital anomalies or medical conditions affecting breastfeeding
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 |
|---|---|---|
| Post-frenotomy manual manipulationAlso: Post-procedural exercisesParents assigned to the treatment group will be instructed to perform post-frenotomy stretches and exercises four times daily, after every other feed, until the time of their postoperative visit 2-3 weeks later. | Other | Exercise Group |
Primary outcome
Proportion of infants who are recommended to undergo repeat frenotomy
Time frame: From enrollment to the 2-3 week postoperative visit
Recommendations for frenotomy revision will be made by the principal investigator during the post-operative visit, which occurs 2-3 weeks following the procedure. This will include a physical examination to assess post-operative healing, along with an evaluation of the mother's breastfeeding outcomes.
Improvement in breastfeeding performance following post-procedural manual manipulation
Time frame: From enrollment to the 2-3 week postoperative visit
Pre- and post-operative maternal breastfeeding performance will be assessed using the LATCH score, a validated questionnaire that evaluates breastfeeding effectiveness. The pre-operative score will be administered during the initial consultation, while the post-operative score will be taken at the follow-up visit, 2-3 weeks after the procedure. The difference in scores will be analyzed to determine if there is an improvement in maternal breastfeeding outcomes.
1 secondary outcome
Compliance with post-frenotomy stretching and exercises
Time frame: From enrollment to the 1 week postoperative phone call
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 33852342LeFort Y, Evans A, Livingstone V, Douglas P, Dahlquist N, Donnelly B, Leeper K, Harley E, Lappin S. Academy of Breastfeeding Medicine Position Statement on Ankyloglossia in Breastfeeding Dyads. Breastfeed Med. 2021 Apr;16(4):278-281. doi: 10.1089/bfm.2021.29179.ylf. No abstract available.
- Results publication: PubMed 32283998Messner AH, Walsh J, Rosenfeld RM, Schwartz SR, Ishman SL, Baldassari C, Brietzke SE, Darrow DH, Goldstein N, Levi J, Meyer AK, Parikh S, Simons JP, Wohl DL, Lambie E, Satterfield L. Clinical Consensus Statement: Ankyloglossia in Children. Otolaryngol Head Neck Surg. 2020 May;162(5):597-611. doi: 10.1177/0194599820915457. Epub 2020 Apr 14.
- 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.
Earl H Harley, MD principal investigator
MedStar Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-frenotomy manual manipulation in people with Ankyloglossia and Breastfeeding Support, run by Georgetown University 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily A Clementi, BA ((202) 444-8186, eac166@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of infants who are recommended to undergo repeat frenotomy (time frame: From enrollment to the 2-3 week postoperative visit). The study lists 2 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 NCT06830148, which also lists 2 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 17 Feb 2025.