The Scope of Tongue-tie in Norway: Its Prevalence and Consequences for Child Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Scope of Tongue-tie in Norway: Its Prevalence and Consequences for Child Health

Conditions
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Tongue Tie, Ankyloglossia

Intervention / Treatment
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* Procedure: Frenotomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 2 Weeks

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants diagnosed with a tongue-tie and a frenotomy<br>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. | Procedure: Frenotomy<br>* 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.<br>* Other names: Breastfeeding support;|
| Infants diagnosed with a tongue-tie and no frenotomy<br>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<br>All the infants born in the study period that will contribute to the prevalence study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of ankyloglossia in Norway | The to assess the prevalence of tongue-tie in newborn infants in Norway. | September 2019 - August 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | September 2019 - December 2021 | 
| Adverse events | Severity of adverse events related to the treatment of the infant as assessed by CTCAE v5.0. | September 2019 - December 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Lactational mastitis, Infant nutrition, Infant growth, Speech development, Frenotomy