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Lingual Frenulum in Newborn Infants (LINNE)

NCT05560750 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • Tongue Tie
  • Frenulum Breve
  • Frenulum; Elongation
  • Breast Feeding

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

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Outi Aikio, MD, PhD · Oulu University Hospital, Dept of Pediatrics; PEDEGO Research unit and MRC Oulu, University of Oulu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2026-01-23
Completion
2028-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560750 on ClinicalTrials.gov