Clinical Trial

Lingual Frenulum in Newborn Infants (LINNE)

Study acronym: LINNE
Active, Not Recruiting
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Record status
This record was last updated January 8, 2026 (before its estimated January 23, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-09-26; most recent amendment 2026-01-07.
Status change: Recruiting → Active, Not Recruiting 2026-01-07
Status change: Not Yet Recruiting → Recruiting 2022-11-01
Trial Details
NCT Number NCT05560750
Lead Sponsor University of Oulu
Conditions Tongue Tie, Frenulum Breve, Frenulum; Elongation, Breast Feeding
Enrollment 300 participants
Start Date 2022-10-03
Primary Completion 2026-01-23 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-08