Neonatal Tongue-tiePhase 1/2NCT01274247
Use of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn
A Phase 1/2 study testing Topical Benzocaine in people with Neonatal Tongue-tie and Maternal Nipple Pain Upon Breastfeeding, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Frenotomy of tongue-tie is commonly performed to resolve breastfeeding difficulties, eg maternal nipple pain and infant's latching difficulties. The procedure carries minor discomfort for the infants. Read more about this study
- Who is it for?
- Ages 12 hours to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Tongue-tie, Maternal Nipple Pain Upon Breastfeeding, Neonatal Latch Difficulties
- What is being tested?
- Topical Benzocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Jun 2012
- Phase
- Phase 1/2
- 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 12 hours to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full term Newborn infant
- Tongue-tie upon physical examination
- Maternal complains of nipple pain or difficult latch
Who cannot join
- Abnormal oral or nasopharyngeal anatomy
- Any known congenital malformations
- Prematurity
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Neonatology, Tel AViv Medical Center
Tel Aviv, 64239
About this study
Official title: Time of Cry After Lingual Frenotomy in Infants With Lingual Frenulum and Breastfeeding Difficulties, With or Without Use of Topical Benzocaine Analgesia
Frenotomy of tongue-tie is commonly performed to resolve breastfeeding difficulties, eg maternal nipple pain and infant's latching difficulties. The procedure carries minor discomfort for the infants. It is not known whether the use of topical benzocaine, a very bitter tasting material' applied to the tongue-tie would decrease the length of cry. We will measure the duration of crying in infants treated with topical benzocaine to the duration in those not treated with the mediation.
- Being tested
- Topical Benzocaine
- Keywords
- Tongue-tie, Ankyloglossia
- Medical subject headings
- Ankyloglossia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical BenzocaineDrug
Topical administration of a drop of benzocaine to the lingual frenulum
| Study group | Role | What they receive |
|---|---|---|
| Topical Benzocaine | Active comparator | For infants treated with topical benzocaine prior to the procedure Receives: Drug: Topical Benzocaine |
| no benzocaine | No intervention | No benzocaine applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of cry after lingual frenotomy
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: The study ethics committee recommended concluding the study for longer crying time with benzocaine and very short crying time in all participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Tongue-tieStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shaul Dollberg, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274247
- Sponsor's protocol ID
- TASMC-10-SD-0385-CTIL
- Status last verified
- Aug 2012
- First submitted
- 10 Jan 2011
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time of Cry After Lingual Frenotomy in Infants With Lingual Frenulum and Breastfeeding Difficulties, With or Without Use of Topical Benzocaine Analgesia
- ClinicalTrials.gov ID
- NCT01274247
- Acronym / sponsor ID
- TASMC-10-SD-0385-CTIL
- Keywords
- Tongue-tie, Ankyloglossia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study ethics committee recommended concluding the study for longer crying time with benzocaine and very short crying time in all participants.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Jan 2011 (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.
Frenotomy of tongue-tie is commonly performed to resolve breastfeeding difficulties, eg maternal nipple pain and infant's latching difficulties. The procedure carries minor discomfort for the infants. It is not known whether the use of topical benzocaine, a very bitter tasting material' applied to the tongue-tie would decrease the length of cry. We will measure the duration of crying in infants treated with topical benzocaine to the duration in those not treated with the mediation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Benzocaine | Active comparator | Drug: Topical BenzocaineFor infants treated with topical benzocaine prior to the procedure |
| no benzocaine | No intervention | –No benzocaine applied |
Who may qualify
- Ages
- 12 hours to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Full term Newborn infant
- Tongue-tie upon physical examination
- Maternal complains of nipple pain or difficult latch
Key exclusion criteria (3 listed)
- Abnormal oral or nasopharyngeal anatomy
- Any known congenital malformations
- Prematurity
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 |
|---|---|---|
| Topical BenzocaineTopical administration of a drop of benzocaine to the lingual frenulum | Drug | Topical Benzocaine |
Primary outcome
Duration of cry after lingual frenotomy
Time frame: 10 minutes
Results and safety
The study was stopped early (reason given: The study ethics committee recommended concluding the study for longer crying time with benzocaine and very short crying time in all participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
Related trials for Neonatal Tongue-tie
Active, not recruiting
Case Series of Infants With Anterior Ankyloglossia Being Treated by the Sublingual Neonatal Incision Platform Device
Ankyloglossia
Active, not recruiting
Lingual Frenulum in Newborn Infants (LINNE)
Tongue Tie, Frenulum Breve
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.
Shaul Dollberg, MD principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Topical Benzocaine in people with Neonatal Tongue-tie and Maternal Nipple Pain Upon Breastfeeding, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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: stopped early, as of the sponsor's last update on 2 Aug 2012. 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 Israel. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study ethics committee recommended concluding the study for longer crying time with benzocaine and very short crying time in all participants.). Results are not available in the source record.
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?
Duration of cry after lingual frenotomy (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2012.