Tongue TieNCT04056936
The Scope of Tongue-tie in Norway: Its Prevalence and Consequences for Child Health
An observational study of Tongue Tie and Ankyloglossia, run by University of Oslo.
Trial summary
The study is a prospective multi-centre clinical follow-up study of prevalence and severity of tongue-tie in neonates in Norway. During one year around 2600 newborn infants will be examined for tongue-tie in the two participating hospitals. Read more about this study
- Who is it for?
- Ages 1 day to 2 weeks
- Conditions the study is for
- Tongue Tie, Ankyloglossia
- What is being tested?
- Frenotomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 31 Aug 2022
- Phase
- Observational
- 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 1 day to 2 weeks
- All sexes
- Child
Study population: Infants 0 days to 2 weeks old diagnosed with a tongue tie in the counties of Telemark and Vestfold during the study enrollment period September 2019 - August 2020.
Who may be able to join
- Subject must be born in a participating hospital during the study period.
- Subjects that are recruited for follow-up must have a diagnose of tongue-tie as determined by the pediatrician in the hospital.
- Infants with a tongue-tie that have been treated with a frenotomy and infants that have not received treatment.
Who cannot join
- Infants where the parents do not wish to participate in the study or where the parents do not to understand English or Norwegian.
Trial locations and contacts
No sites are listed yet.
About this study
The study is a prospective multi-centre clinical follow-up study of prevalence and severity of tongue-tie in neonates in Norway. During one year around 2600 newborn infants will be examined for tongue-tie in the two participating hospitals. The infants diagnosed with a tongue tie, will be followed to assess the proportion of infants treated and the severity. Feeding outcomes will be observed up to 6 months of age.
Read the detailed description
A tongue-tie may cause problems for child and mother. There are no previous studies from Norway that have assessed the magnitude and severity of tongue-tie in infants. The prevalence of tongue-tie in Norway and to what degree it influences mother and child health is unknown. It is of great importance to address a problem with possible negative effect on breastfeeding and maternal and child health. Current clinical practice varies due to incomplete knowledge of the condition. An unknown proportion of infants with tongue-tie may not be diagnosed or receive treatment. Current international research recommends treatment of tongue-tie if it causes breastfeeding problems. This project will add significant knowledge about tongue-tie in Norway.
The project supports:
- Filling knowledge gaps by researching the prevalence and severity of the condition.
- Obtaining new knowledge for the health services by establishing assessment of tongue-tie prevalence in Norway. This can be used for planning of the healthcare services.
- Improving existing practice by describing the condition and implementing best practice diagnosis and treatment.
- Creating societal benefits by improving infant nutrition and maternal health.
During the year of the study, the pediatricians at each hospital will assess the prevalence of tongue-tie in all newborn infants in their hospital. The examination will be part of the standard newborn examination which usually takes place during the 2nd day of life. A simple and short registration form will be filled out electronically, noting the type of tongue-tie and symptoms for each infant with the diagnosis. In addition, the diagnosis Ankyloglossia Q38.1 will be registered in the electronic journal system. The examination of the infant's mouth is completely safe and is already performed to asses if there is a cleft palate. The pediatrician will examine the area under the tongue in addition to the palate. All newborn infants will be examined to obtain a trustworthy prevalence. If a frenotomy is required and performed, this will be registered in the registration form and the procedure code for frenotomy EJC 20 will be registered in the electronic journal system. The breastfeeding self-efficacy tool (BSES-SF) is used for patient reported outcome measures.as well as WHO's breastfeeding indicators
To map the severity determining any possible consequences a tongue-tie may have for breastfeeding and infant nutrition the investigators will follow-up a cohort of tongue-tied infants to register if the feeding, growth, thriving and speech of the infant/child is affected by a tongue-tie.
- Conditions
- Tongue Tie, Ankyloglossia
- Being tested
- Frenotomy
- Keywords
- Breastfeeding, Lactational mastitis, Infant nutrition, Infant growth, Speech development, Frenotomy
- 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.
FrenotomyProcedure or surgery
Also called Breastfeeding support
To map the severity determining any possible consequences a tongue-tie may have for breastfeeding and infant nutrition we will follow-up a cohort of tongue-tied infants to register if the feeding, growth, thriving and speech of the infant/child is affected by a tongue-tie.
| Study group | Role | What they receive |
|---|---|---|
| Infants diagnosed with a tongue-tie and a frenotomy | If a tongue-tie is present at the routine newborn examination, the infant can be included in the study. If the infant also has breastfeeding problems and there is a decreased tongue mobility and poor sucking ability, the pediatrician may find indication for frenotomy. If the frenotomy is performed before discharge the infant is included in this group. All Mother-infant dyads will get breastfeeding support. Receives: Procedure: Frenotomy | |
| Infants diagnosed with a tongue-tie and no frenotomy | The infants that are recruited to the tongue-tie cohort that do not receive treatment before discharge. The pediatrician evaluates that the tongue tie does not cause any functional problems and no treatment is performed before discharge. All Mother-infant dyads will get breastfeeding support. | |
| All infants born in Telemark and Vestfold Counties | All the infants born in the study period that will contribute to the prevalence study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ankyloglossia in Norway
The to assess the prevalence of tongue-tie in newborn infants in Norway.
Measured: September 2019 - August 2021
Secondary outcomes (4)
Proportion of infants treated with a frenotomy
The number of infants treated on indication after the standardized diagnostic approach and the method of treatment have been introduced in the centers of intervention.
Measured: September 2019 - December 2021
Variations in diagnosis of tongue tie and breastfeeding outcomes
Number of infants with the diagnosis Q38.1 in the intervention counties compared to counties that are not a part of the study.
Measured: September 2019 - December 2021
Severity of breastfeeding problems
Breastfeeding problems and the duration of exclusive breastfeeding measured in months in the tongue tied infants that receive treatment compared to those who are not treated.
Measured: September 2019 - December 2021
Adverse events
Severity of adverse events related to the treatment of the infant as assessed by CTCAE v5.0.
Measured: September 2019 - December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue TieStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital of Vestfold, Oslo University Hospital, Sykehuset Telemark
- Responsible party
- Principal investigator, Atle Klovning, University of Oslo
- Investigators
- Atle Klovning, MD. PhD, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056936
- Sponsor's protocol ID
- 2018/FO201556
- Status last verified
- Aug 2019
- First submitted
- 24 Jun 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Scope of Tongue-tie in Norway: Its Prevalence and Consequences for Child Health
- ClinicalTrials.gov ID
- NCT04056936
- Acronym / sponsor ID
- 2018/FO201556
- Conditions
- Tongue Tie, Ankyloglossia
- Keywords
- Breastfeeding, Lactational mastitis, Infant nutrition, Infant growth, Speech development, Frenotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- The Hospital of Vestfold, Oslo University Hospital, Sykehuset Telemark
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 14 Aug 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.
The study is a prospective multi-centre clinical follow-up study of prevalence and severity of tongue-tie in neonates in Norway. During one year around 2600 newborn infants will be examined for tongue-tie in the two participating hospitals. The infants diagnosed with a tongue tie, will be followed to assess the proportion of infants treated and the severity. Feeding outcomes will be observed up to 6 months of age.
Detailed description
A tongue-tie may cause problems for child and mother. There are no previous studies from Norway that have assessed the magnitude and severity of tongue-tie in infants. The prevalence of tongue-tie in Norway and to what degree it influences mother and child health is unknown. It is of great importance to address a problem with possible negative effect on breastfeeding and maternal and child health. Current clinical practice varies due to incomplete knowledge of the condition. An unknown proportion of infants with tongue-tie may not be diagnosed or receive treatment. Current international research recommends treatment of tongue-tie if it causes breastfeeding problems. This project will add significant knowledge about tongue-tie in Norway.
The project supports:
- Filling knowledge gaps by researching the prevalence and severity of the condition.
- Obtaining new knowledge for the health services by establishing assessment of tongue-tie prevalence in Norway. This can be used for planning of the healthcare services.
- Improving existing practice by describing the condition and implementing best practice diagnosis and treatment.
- Creating societal benefits by improving infant nutrition and maternal health.
During the year of the study, the pediatricians at each hospital will assess the prevalence of tongue-tie in all newborn infants in their hospital. The examination will be part of the standard newborn examination which usually takes place during the 2nd day of life. A simple and short registration form will be filled out electronically, noting the type of tongue-tie and symptoms for each infant with the diagnosis. In addition, the diagnosis Ankyloglossia Q38.1 will be registered in the electronic journal system. The examination of the infant's mouth is completely safe and is already performed to asses if there is a cleft palate. The pediatrician will examine the area under the tongue in addition to the palate. All newborn infants will be examined to obtain a trustworthy prevalence. If a frenotomy is required and performed, this will be registered in the registration form and the procedure code for frenotomy EJC 20 will be registered in the electronic journal system. The breastfeeding self-efficacy tool (BSES-SF) is used for patient reported outcome measures.as well as WHO's breastfeeding indicators
To map the severity determining any possible consequences a tongue-tie may have for breastfeeding and infant nutrition the investigators will follow-up a cohort of tongue-tied infants to register if the feeding, growth, thriving and speech of the infant/child is affected by a tongue-tie.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infants diagnosed with a tongue-tie and a frenotomy | – | Procedure: FrenotomyIf a tongue-tie is present at the routine newborn examination, the infant can be included in the study. If the infant also has breastfeeding problems and there is a decreased tongue mobility and poor sucking ability, the pediatrician may find indication for frenotomy. If the frenotomy is performed before discharge the infant is included in this group. All Mother-infant dyads will get breastfeeding support. |
| Infants diagnosed with a tongue-tie and no frenotomy | – | –The infants that are recruited to the tongue-tie cohort that do not receive treatment before discharge. The pediatrician evaluates that the tongue tie does not cause any functional problems and no treatment is performed before discharge. All Mother-infant dyads will get breastfeeding support. |
| All infants born in Telemark and Vestfold Counties | – | –All the infants born in the study period that will contribute to the prevalence study. |
Who may qualify
- Ages
- 1 day to 2 weeks
- Sex
- All
- Age groups
- Child
- Study population
- Infants 0 days to 2 weeks old diagnosed with a tongue tie in the counties of Telemark and Vestfold during the study enrollment period September 2019 - August 2020.
Key inclusion criteria (3 listed)
- Subject must be born in a participating hospital during the study period.
- Subjects that are recruited for follow-up must have a diagnose of tongue-tie as determined by the pediatrician in the hospital.
- Infants with a tongue-tie that have been treated with a frenotomy and infants that have not received treatment.
Key exclusion criteria (1 listed)
- Infants where the parents do not wish to participate in the study or where the parents do not to understand English or Norwegian.
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 |
|---|---|---|
| FrenotomyAlso: Breastfeeding supportTo map the severity determining any possible consequences a tongue-tie may have for breastfeeding and infant nutrition we will follow-up a cohort of tongue-tied infants to register if the feeding, growth, thriving and speech of the infant/child is affected by a tongue-tie. | Procedure or surgery | Infants diagnosed with a tongue-tie and a frenotomy |
Primary outcome
Prevalence of ankyloglossia in Norway
Time frame: September 2019 - August 2021
The to assess the prevalence of tongue-tie in newborn infants in Norway.
4 secondary outcomes
Proportion of infants treated with a frenotomy
Time frame: September 2019 - December 2021
Variations in diagnosis of tongue tie and breastfeeding outcomes
Time frame: September 2019 - December 2021
Severity of breastfeeding problems
Time frame: September 2019 - December 2021
Adverse events
Time frame: September 2019 - December 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- 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.
Atle Klovning, MD. PhD study director
University of Oslo
Questions about this trial
What is this clinical trial studying?
An observational study of Tongue Tie and Ankyloglossia, run by University of Oslo.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rønnaug Solberg, MD, PhD (+ 47-91843808, Ronnaug.Solberg@rr-research.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ankyloglossia in Norway (time frame: September 2019 - August 2021). 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 19 Aug 2019.