UnknownNot Applicable

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

100 participantsStarted 2019-09-01

Plain-language 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.

Who can participate

Age range

1 Day – 2 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of ankyloglossia in Norway

Timeframe: September 2019 - August 2021

Trial details

NCT IDNCT04056936

SponsorUniversity of Oslo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-08-31

Contact for this trial

Rønnaug Solberg, MD, PhD

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

View on ClinicalTrials.gov More Tongue Tie trials