BreastfeedingNCT00970255
Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties
A study testing Lingual Frenulum frenotomy in people with Breastfeeding, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Upper lingual frenulum have been implicated as a cause for pain during breastfeeding and latch problems. The investigators hypothesize that performing frenotomy of the frenulum may improve breastfeeding. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Lingual Frenulum frenotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2009to Oct 2015
- 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 Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- breastfeeding infants
- maternal nipple pain
- latching problems
Who cannot join
- oral cavity anomalies
- breast anatomical anomalies
- untreated tongue-tie in infant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Labial Frenulum Clipping on Nipple Pain and Latch Problems in Breastfeeding Infants
Upper lingual frenulum have been implicated as a cause for pain during breastfeeding and latch problems. The investigators hypothesize that performing frenotomy of the frenulum may improve breastfeeding. The investigators will include breastfeeding infants with pain or latch problems in whom the lingual frenulum had been treated but breastfeeding problems were not resolved. The investigators plan to study the effect of frenotomy of the upper lingual frenulum on maternal pain (using pain score by visual analog scale) and/or latch score.
- Conditions
- Breastfeeding
- Being tested
- Lingual Frenulum frenotomy, Sham frenotomy
- Keywords
- Breastfeeding difficulties, lingual frenulum, labial frenulum, frenotomy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual Frenulum frenotomyProcedure or surgery
Clipping the lingual frenulum with scissors
Sham frenotomyProcedure or surgery
Sham Clipping the lingual frenulum with scissors
| Study group | Role | What they receive |
|---|---|---|
| Frenotomy | Active comparator | Not described Receives: Procedure: Lingual Frenulum frenotomy |
| Sham Frenotomy | Sham comparator | Not described Receives: Procedure: Sham frenotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score by Visual Analog Scale
Measured: Within 30 minutes
Latch Score
Measured: Within 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2015 (estimated)
Why it stopped: Difficulty in recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970255
- Sponsor's protocol ID
- TASMC-08-SD-0559-CTIL
- Status last verified
- Aug 2012
- First submitted
- 1 Sep 2009
- 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
- Effect of Labial Frenulum Clipping on Nipple Pain and Latch Problems in Breastfeeding Infants
- ClinicalTrials.gov ID
- NCT00970255
- Acronym / sponsor ID
- TASMC-08-SD-0559-CTIL
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding difficulties, lingual frenulum, labial frenulum, frenotomy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Difficulty in recruiting participants
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2009
- Primary completion
- Oct 2015 (estimated)
- First posted
- 2 Sep 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.
Upper lingual frenulum have been implicated as a cause for pain during breastfeeding and latch problems. The investigators hypothesize that performing frenotomy of the frenulum may improve breastfeeding. The investigators will include breastfeeding infants with pain or latch problems in whom the lingual frenulum had been treated but breastfeeding problems were not resolved. The investigators plan to study the effect of frenotomy of the upper lingual frenulum on maternal pain (using pain score by visual analog scale) and/or latch score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frenotomy | Active comparator | Procedure: Lingual Frenulum frenotomy |
| Sham Frenotomy | Sham comparator | Procedure: Sham frenotomy |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- breastfeeding infants
- maternal nipple pain
- latching problems
Key exclusion criteria (3 listed)
- oral cavity anomalies
- breast anatomical anomalies
- untreated tongue-tie in infant
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 Frenulum frenotomyClipping the lingual frenulum with scissors | Procedure or surgery | Frenotomy |
| Sham frenotomySham Clipping the lingual frenulum with scissors | Procedure or surgery | Sham Frenotomy |
Primary outcome
Pain score by Visual Analog Scale
Time frame: Within 30 minutes
Latch Score
Time frame: Within 30 Minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
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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 Lingual Frenulum frenotomy in people with 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: paused, 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. 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?
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?
Pain score by Visual Analog Scale (time frame: Within 30 minutes). 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?
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.