NCT04703946

Incidence of Short Sublingual Frenulum in Newborns at the Hospital Nostra Senyora de Meritxell.

Ankyloglossia in Neonates. Incidence of Short Sublingual Frenulum in Newborns at the Hospital Nostra Senyora de Meritxell. Relationship With Auxological Data, Associated Malformations or Diseases and Hereditary Component of the Newborn.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,167 (actual)
• Sponsor: Universitat Internacional de Catalunya · Academic / Other
• Sex: All
• Age: 1 Minute – 2 Weeks
• Healthy volunteers: Accepted

Summary

The aim of the study was to analyze the incidence of short sublingual frenulum in newborns of the Hospital Nostra Senyora de Meritxell of the Principat of Andorra.

Detailed description

Thus, the objective of this study was to determine the incidence of AG in newborns of the Hospital Nostra Senyora de Meritxell of the Principat of Andorra, as well as the relationship with auxological data, associated malformations or diseases and hereditary component of the newborn. A random sample of 2167 individuals is enough to estimate, with a confidence of 95% and an accuracy of +/- 1 percentage units, a population percentage that is projected to be around 6%. The percentage of replenishment required is projected to be 0%. With this sample, it will be sufficient to estimate the children who have ankyloglossia, the % of relatives who also have it (a population percentage that is projected to be around 25%). Confidential and anonymous collection of data from patients' medical records for a period of 2 years and 8 months, and write them down in a database to finally correlate them and see if there is any association with the parameters studied.

Conditions

• Ankyloglossia

Interventions

Type	Name	Description
OTHER	observacional	Analyze the incidence of short sublingual frenulum in newborns of the Hospital Nostra Senyora de Meritxell of the Principat of Andorra. 1. Association or not of the AG with auxological parameters (weight, height, cranial perimeter) at birth. 2. Association or not of the AG with sex. 3. Association or not of the AG with gestational age. 4. Association or not of the AG with other minor and major malformations.

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2021-01-11
• Last updated: 2021-05-11

Locations

1 site across 1 country: Spain