AnkyloglossiaNCT00967915
Efficacy of Neonatal Release of Ankyloglossia
A study testing Frentomy in people with Ankyloglossia, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
Trial summary
The purpose of this study is to determine if frenotomy for ankyloglossia will improve infant breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the hypothesis that frenotomy will do all of the above. Read more about this study
- Who is it for?
- Ages 0 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Ankyloglossia
- What is being tested?
- Frentomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jul 2009
- 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 0 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Significant ankyloglossia as judged by Hazelbaker scale (HATLFF)
- Report of maternal nipple pain with feeding
- Report of difficulty with infant breast feeding
Who cannot join
- Significant craniofacial defects
- Age >14 days at enrollment
- Any maternal contraindication to breastfeeding
- Neurologic defects that would impair breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
About this study
The purpose of this study is to determine if frenotomy for ankyloglossia will improve infant breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the hypothesis that frenotomy will do all of the above.
Read the detailed description
The primary objective of our study is to determine if frenotomy (or release of tongue tie) for ankyloglossia (tongue tie) will decrease maternal nipple pain with breast feeding and improve infant's ability to breast feed. Our secondary objective is to determine if frenotomy for ankyloglossia will improve the length of time a mother breast feeds. Our hypothesis is that frenotomy will decrease maternal nipple pain, improve infant's breast feeding and prolong the duration of breast feeding.
- Conditions
- Ankyloglossia
- Being tested
- Frentomy, Sham procedure
- Keywords
- Ankyloglossia, Tongue tie, Frenotomy, Frenulectomy, Breast feeding, HATLFF, IBFAT
- Medical subject headings
- Ankyloglossia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FrentomyProcedure or surgery
Frenotomy will be performed. This procedure involves crushing frenulum tissue with straight hemostat for hemostasis and anesthesia while tongue is elevated with elevator. Frenulum then cut to desired length with iris scissors. Patient then returned to parents and immediately breastfeeds without parent observing infant's mouth.
Sham procedureOther
Infant taken into room away from parents and no frenotomy performed. Infant's mouth is examined but no interventions made.
| Study group | Role | What they receive |
|---|---|---|
| Frenotomy | Experimental | Group of neonates that will receive frenotomy for tongue-tie Receives: Procedure: Frentomy |
| No frenotomy | Sham comparator | Group of infants that will undergo sham procedure (no frenotomy performed) Receives: Other: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal nipple pain as judged by R. Melzack's short form pain scale and infant breast feeding as judged by IBFAT scale
Measured: immediately following 1st breast feed, and at 2 week, 2,4,6 12 month follow ups
Secondary outcomes (1)
Length of breast feeding
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startNov 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Single blind
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967915
- Sponsor's protocol ID
- 2007.0077
- Status last verified
- May 2024
- First submitted
- 27 Aug 2009
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Buryk M, Bloom D, Shope T. Efficacy of neonatal release of ankyloglossia: a randomized trial. Pediatrics. 2011 Aug;128(2):280-8. doi: 10.1542/peds.2011-0077. Epub 2011 Jul 18.
PubMed 21768318
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Neonatal Release of Ankyloglossia
- ClinicalTrials.gov ID
- NCT00967915
- Acronym / sponsor ID
- 2007.0077
- Conditions
- Ankyloglossia
- Keywords
- Ankyloglossia, Tongue tie, Frenotomy, Frenulectomy, Breast feeding, HATLFF, IBFAT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- Nov 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 28 Aug 2009 (estimated)
- 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 purpose of this study is to determine if frenotomy for ankyloglossia will improve infant breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the hypothesis that frenotomy will do all of the above.
Detailed description
The primary objective of our study is to determine if frenotomy (or release of tongue tie) for ankyloglossia (tongue tie) will decrease maternal nipple pain with breast feeding and improve infant's ability to breast feed. Our secondary objective is to determine if frenotomy for ankyloglossia will improve the length of time a mother breast feeds. Our hypothesis is that frenotomy will decrease maternal nipple pain, improve infant's breast feeding and prolong the duration of breast feeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frenotomy | Experimental | Procedure: FrentomyGroup of neonates that will receive frenotomy for tongue-tie |
| No frenotomy | Sham comparator | Other: Sham procedureGroup of infants that will undergo sham procedure (no frenotomy performed) |
Who may qualify
- Ages
- 0 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Significant ankyloglossia as judged by Hazelbaker scale (HATLFF)
- Report of maternal nipple pain with feeding
- Report of difficulty with infant breast feeding
Key exclusion criteria (4 listed)
- Significant craniofacial defects
- Age >14 days at enrollment
- Any maternal contraindication to breastfeeding
- Neurologic defects that would impair breast feeding
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 |
|---|---|---|
| FrentomyFrenotomy will be performed. This procedure involves crushing frenulum tissue with straight hemostat for hemostasis and anesthesia while tongue is elevated with elevator. Frenulum then cut to desired length with iris scissors. Patient then returned to parents and immediately breastfeeds without parent observing infant's mouth. | Procedure or surgery | Frenotomy |
| Sham procedureInfant taken into room away from parents and no frenotomy performed. Infant's mouth is examined but no interventions made. | Other | No frenotomy |
Primary outcome
Maternal nipple pain as judged by R. Melzack's short form pain scale and infant breast feeding as judged by IBFAT scale
Time frame: immediately following 1st breast feed, and at 2 week, 2,4,6 12 month follow ups
1 secondary outcome
Length of breast feeding
Time frame: 1 year follow up
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 10 May 2024.
- Derived from this study: PubMed 21768318Buryk M, Bloom D, Shope T. Efficacy of neonatal release of ankyloglossia: a randomized trial. Pediatrics. 2011 Aug;128(2):280-8. doi: 10.1542/peds.2011-0077. Epub 2011 Jul 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frentomy in people with Ankyloglossia, run by United States Naval Medical Center, Portsmouth 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 4 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 10 May 2024. 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. Some participants in this study may receive a placebo. 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?
Maternal nipple pain as judged by R. Melzack's short form pain scale and infant breast feeding as judged by IBFAT scale (time frame: immediately following 1st breast feed, and at 2 week, 2,4,6 12 month follow ups). 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 NCT00967915, which also lists 1 linked publication.
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 10 May 2024.