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Lingual Frenulum in Newborn Infants (LINNE)

Study acronym: LINNE
StatusActive, Not Recruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 21, 2025 to Jan 23, 2026
    • Site details revised at 3 of 3 sites
    v4
  2. Study description expanded, about 4 wordsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 3 of 3 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05560750
Lead Sponsor University of Oulu
Conditions
(from sponsor)		 Tongue Tie, Frenulum Breve, Frenulum; Elongation, Breast Feeding
Related terms Ankyloglossia, Breast Feeding
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov