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Lingual Frenulum in Newborn Infants (LINNE)
Sponsor: University of Oulu
Summary
Oral cavity's structural variations are involved in the successful breastfeeding of the newborn infants. The tongue-tie has been shown to cause breastfeeding problems. This project investigates the oral structural properties of the newborn infants and the efficacy and safety of their treatment options in breastfeeding problems. The project includes two studies: 1. A prospective follow-up study that investigates the epidemiology and associations between oral structures and breastfeeding problems in term and preterm infants; 2. A randomised, controlled study that investigates the efficacy and safety of tongue-tie treatments. Follow-up visits are planned two to three months, one year, and five years after randomisation along with a 6 months' e-questionnaire for all study patients. The study provides information at the population level.
Official title: Lingual Frenulum in Newborn Infants (LINNE): Prospective, Observational Study of the Oral Structural Variations, Their Correlations to the Functional Distinctions, and a Randomized, Controlled Trial on the Treatment of the Tongue-tie
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2022-10-03
Completion Date
2028-12-31
Last Updated
2026-01-08
Healthy Volunteers
No
Interventions
Frenotomy
Releasing the tongue-tie with scissors
Oral physiotherapy
Gentle parental activation of the mouth area and the tongue for 1 month
Locations (3)
Department of Otorhinolaryngology, Oulu University Hospital
Oulu, Finland
Department of Pediatrics, Oulu University Hospital
Oulu, Finland
University of Oulu, Faculty of Humanities, Research Unit of Logopedics
Oulu, Finland