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Search / Trial NCT05560750

Lingual Frenulum in Newborn Infants (LINNE)

Launched by UNIVERSITY OF OULU · Sep 26, 2022

Trial Information

Current as of November 12, 2025

Recruiting

Keywords

Tongue Tie Frenulum Lingualis Frenotomy Oral Physiotherapy Newborn Infant Breastfeeding Breastfeeding Complications Logopedic Evaluation

ClinConnect Summary

The LINNE trial is studying how certain tongue issues in newborns, known as tongue-tie, can affect breastfeeding. Tongue-tie happens when the tissue connecting the tongue to the bottom of the mouth is too short or tight, making it hard for babies to latch on and feed properly. This study aims to understand how common these issues are in both full-term and premature babies and to evaluate different treatment options for tongue-tie to see which ones are safe and effective.

To participate in this trial, newborns must have a tongue-tie that is making breastfeeding difficult, with a specific scoring system showing significant problems. Unfortunately, babies with serious health issues or those whose parents have communication barriers won't be included. Families who join the study can expect follow-up visits at two to three months, one year, and five years after their child’s treatment, along with a short online questionnaire after six months. Overall, this research will help gather important information about how to better support breastfeeding for infants with tongue-tie.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Newborn infant with at tongue-tie interfering the breastfeeding and patient's study screening scoring exceeding \>8/19
  • Exclusion Criteria:
  • Child's severe anomaly or illness; the parent's severe illness; a communication problem between parents and researchers (e.g. language barrier); any other practical reason that prevents the child to have the procedure or the parents to provide the oral physiotherapy

About University Of Oulu

The University of Oulu, located in Finland, is a leading research institution known for its commitment to advancing scientific knowledge and innovation in various fields, including health sciences. As a clinical trial sponsor, the University of Oulu leverages its extensive academic expertise, state-of-the-art facilities, and collaborative networks to conduct rigorous and ethically sound clinical research. The university emphasizes interdisciplinary approaches and strives to translate research findings into practical applications that improve patient outcomes and contribute to public health. Through its clinical trials, the University of Oulu aims to foster advancements in medical science while adhering to the highest standards of integrity and compliance.

Locations

Oulu, Finland

Oulu, Finland

Oulu, Finland

Patients applied

0 patients applied

Trial Officials

Outi Aikio, MD, PhD

Principal Investigator

Oulu University Hospital, Dept of Pediatrics; PEDEGO Research unit and MRC Oulu, University of Oulu

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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