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

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.

Study Overview

• Status: Unknown
• Conditions: Ankyloglossia; Tongue Tie
• Intervention / Treatment: Procedure: Frenotomy

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 weeks (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Frenotomy; 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.; Other Names: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term followup - Breastfeeding duration and introduction of solids	Duration of any breastfeeding in months and any problems with the introduction of solids is mapped 3 years after inclusion in the study.	September 2019 - August 2023
Long term followup - Speech development	Problems with child's speech development at the age of 3 years. Referral to treatment by Speech Language Pathologist.	September 2019 - August 2023

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Oslo University Hospital; The Hospital of Vestfold; Sykehuset Telemark
• Investigators: Study Director: Atle Klovning, MD. PhD, University of Oslo

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Breastfeeding; Infant growth; Infant nutrition; Lactational mastitis; Speech development; Frenotomy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Ankyloglossia
• Other Study ID Numbers: 2018/FO201556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No