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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Newborn infant with at tongue-tie interfering the breastfeeding and patient's study screening scoring exceeding \>8/19

Locations
Other Locations
Finland
Department of Otorhinolaryngology, Oulu University Hospital
RECRUITING
Oulu
Department of Pediatrics, Oulu University Hospital
RECRUITING
Oulu
University of Oulu, Faculty of Humanities, Research Unit of Logopedics
ACTIVE_NOT_RECRUITING
Oulu
Contact Information
Primary
Outi Aikio, MD, PhD
outi.aikio@ppshp.fi
+358 8 3155810
Backup
Venla Lohi, MD, PhD
venla.lohi@oulu.fi
+358 8 3153472
Time Frame
Start Date: 2022-10-03
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 300
Treatments
Experimental: Frenotomy
Patients who will have frenotomy soon after randomisation, on the same or next day
Active_comparator: Oral physiotherapy
Patients whose parents are guided to give the child oral physiotherapy for 1 month
No_intervention: Follow-up
Patients whose frenotomy appointment will be set at 1 month age
Related Therapeutic Areas
Sponsors
Leads: University of Oulu

This content was sourced from clinicaltrials.gov