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

Ankyloglossia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04056936
• Other study ID #: 2018/FO201556
• Status: Not yet recruiting
• Start date: September 1, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2019
• Source: University of Oslo
• Contact: Rønnaug Solberg, MD, PhD
• Phone: + 47-91843808
• Email: Ronnaug.Solberg[@]rr-research.no
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2020
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Ankyloglossia
• Tongue Tie

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Oslo	Oslo University Hospital, Sykehuset Telemark, The Hospital of Vestfold

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Prevalence of ankyloglossia in Norway	The to assess the prevalence of tongue-tie in newborn infants in Norway.	September 2019 - August 2021
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	Severity of adverse events related to the treatment of the infant as assessed by CTCAE v5.0.	September 2019 - December 2021