Clinical trial NCT04056936: The Scope of Tongue-tie in Norway: Its Prevalence and Consequences for Child Health
Official title: The Scope of Tongue-tie in Norway: Its Prevalence and Consequences for Child Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tongue Tie
Ankyloglossia
Keywords: Breastfeeding
Lactational mastitis
Infant nutrition
Infant growth
Speech development
Frenotomy
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: The Hospital of Vestfold
name: Oslo University Hospital
name: Sykehuset Telemark
First posted: 2019-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Infants where the parents do not wish to participate in the study or where the parents do not to understand English or Norwegian.

Primary outcomes:
measure: Prevalence of ankyloglossia in Norway
timeFrame: September 2019 - August 2021
Secondary outcomes:
measure: Proportion of infants treated with a frenotomy
timeFrame: September 2019 - December 2021
measure: Variations in diagnosis of tongue tie and breastfeeding outcomes
timeFrame: September 2019 - December 2021
measure: Severity of breastfeeding problems
timeFrame: September 2019 - December 2021
measure: Adverse events
timeFrame: September 2019 - December 2021
Other outcomes:
measure: Long term followup - Breastfeeding duration and introduction of solids
timeFrame: September 2019 - August 2023
measure: Long term followup - Speech development
timeFrame: September 2019 - August 2023
Locations:
Study officials:
affiliation: University of Oslo
name: Atle Klovning, MD. PhD
role: STUDY_DIRECTOR
References: