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ACTIVE NOT RECRUITING
NCT05560750
NA

Lingual Frenulum in Newborn Infants (LINNE)

Sponsor: University of Oulu

View on ClinicalTrials.gov

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

PROCEDURE

Frenotomy

Releasing the tongue-tie with scissors

PROCEDURE

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