NCT04056936

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

June 24, 2019

Last Update Submit

August 14, 2019

Conditions

Tongue TieAnkyloglossia

Keywords

BreastfeedingLactational mastitisInfant nutritionInfant growthSpeech developmentFrenotomy

Outcome Measures

Primary Outcomes (1)

  • Prevalence of ankyloglossia in Norway

    The to assess the prevalence of tongue-tie in newborn infants in Norway.

    September 2019 - August 2021

Secondary Outcomes (4)

  • Proportion of infants treated with a frenotomy

    September 2019 - December 2021

  • Variations in diagnosis of tongue tie and breastfeeding outcomes

    September 2019 - December 2021

  • Severity of breastfeeding problems

    September 2019 - December 2021

  • Adverse events

    September 2019 - December 2021

Other Outcomes (2)

  • Long term followup - Breastfeeding duration and introduction of solids

    September 2019 - August 2023

  • Long term followup - Speech development

    September 2019 - August 2023

Study Arms (3)

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

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.

Interventions

FrenotomyPROCEDURE

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.

Also known as: Breastfeeding support
Infants diagnosed with a tongue-tie and a frenotomy

Eligibility Criteria

Age1 Day - 2 Weeks
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AnkyloglossiaBreast Feeding

Interventions

Oral Frenectomy

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Atle Klovning, MD. PhD

    University of Oslo

    STUDY DIRECTOR

Central Study Contacts

Rønnaug Solberg, MD, PhD

CONTACT

+ 47-91843808Ronnaug.Solberg@rr-research.no

Solveig T Holmsen, MD, MPH

CONTACT

+47-95824029soholm@ous-hf.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD. Associate Professor

Study Record Dates

First Submitted

June 24, 2019

First Posted

August 14, 2019

Study Start

September 1, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2022

Last Updated

August 19, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share