Investigating tongue-tie treatments in newborns
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
NA · University of Oulu · NCT05560750
This study is testing different treatments for tongue-tie in newborns to see if they can help improve breastfeeding success for mothers and their babies.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | University of Oulu (other) |
| Locations | 3 sites (Oulu and 2 other locations) |
| Trial ID | NCT05560750 on ClinicalTrials.gov |
What this trial studies
This project examines the structural variations in the oral cavity of newborn infants and their impact on breastfeeding success, particularly focusing on tongue-tie. It includes a prospective follow-up study to explore the epidemiology of oral structures and breastfeeding issues, as well as a randomized controlled trial assessing the efficacy and safety of various treatments for tongue-tie. The study aims to improve breastfeeding experiences for mothers and satisfaction for parents through effective treatment options. Follow-up assessments will occur at multiple intervals to evaluate long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are newborn infants diagnosed with tongue-tie that interferes with breastfeeding.
Not a fit: Patients with severe anomalies or illnesses, or those facing communication barriers that prevent participation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance breastfeeding success rates and improve parental satisfaction through effective treatment of tongue-tie in newborns.
How similar studies have performed: Other studies have shown promising results with similar approaches to treating tongue-tie, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oulu and 2 other locations
- Department of Otorhinolaryngology, Oulu University Hospital — Oulu, Finland (RECRUITING)
- Department of Pediatrics, Oulu University Hospital — Oulu, Finland (RECRUITING)
- University of Oulu, Faculty of Humanities, Research Unit of Logopedics — Oulu, Finland (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Outi Aikio, MD, PhD — Oulu University Hospital, Dept of Pediatrics; PEDEGO Research unit and MRC Oulu, University of Oulu
- Study coordinator: Outi Aikio, MD, PhD
- Email: outi.aikio@ppshp.fi
- Phone: +358 8 3155810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tongue Tie, Frenulum Breve, Frenulum, Elongation, Breast Feeding, Tongue tie, Frenulum lingualis, Frenotomy