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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04056936
Enrollment
100
Registered
2019-08-14
Start date
2019-09-01
Completion date
2022-08-31
Last updated
2019-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankyloglossia, Tongue Tie

Keywords

Breastfeeding, Lactational mastitis, Infant nutrition, Infant growth, Speech development, Frenotomy

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.

Interventions

PROCEDUREFrenotomy

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.

Sponsors

The Hospital of Vestfold
CollaboratorOTHER
Oslo University Hospital
CollaboratorOTHER
Sykehuset Telemark
CollaboratorOTHER_GOV
University of Oslo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 2 Weeks

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of ankyloglossia in NorwaySeptember 2019 - August 2021The to assess the prevalence of tongue-tie in newborn infants in Norway.

Secondary

MeasureTime frameDescription
Variations in diagnosis of tongue tie and breastfeeding outcomesSeptember 2019 - December 2021Number of infants with the diagnosis Q38.1 in the intervention counties compared to counties that are not a part of the study.
Severity of breastfeeding problemsSeptember 2019 - December 2021Breastfeeding 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.
Proportion of infants treated with a frenotomySeptember 2019 - December 2021The number of infants treated on indication after the standardized diagnostic approach and the method of treatment have been introduced in the centers of intervention.
Adverse eventsSeptember 2019 - December 2021Severity of adverse events related to the treatment of the infant as assessed by CTCAE v5.0.

Other

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

Contacts

Primary ContactRønnaug Solberg, MD, PhD
Ronnaug.Solberg@rr-research.no+ 47-91843808
Backup ContactSolveig T Holmsen, MD, MPH
soholm@ous-hf.no+47-95824029

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026