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

Ankyloglossia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703946
• Other study ID #: UIC-ODP-ANDORRA
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2021
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2167
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

Inclusion Criteria:

• The inclusion criteria are patients born from July 2018 to February 2021 (both inclusive) and of both genders.

Exclusion Criteria:

• The exclusion criteria are all those who were born abroad and who after 24 hours go to the Hospital of Andorra, those urgently transferred to other foreign centers after birth, as well as those who present medical records with lack of information.

Related Conditions & MeSH terms

• Ankyloglossia

Intervention

Other:
• observacional
Analyze the incidence of short sublingual frenulum in newborns of the Hospital Nostra Senyora de Meritxell of the Principat of Andorra. Association or not of the AG with auxological parameters (weight, height, cranial perimeter) at birth. Association or not of the AG with sex. Association or not of the AG with gestational age. Association or not of the AG with other minor and major malformations.

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat del Vallès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	height	height	2 weeks
Other	weight	weight	2 weeks
Other	cranial perimeter	cranial perimeter	2 weeks
Other	sex	sex	2 weeks
Other	type of lactation	type of lactation	2 weeks
Other	hereditary factor (if the parents presented/present or not AG)	hereditary factor (if the parents presented/present or not AG)	2 weeks
Primary	Ankilloglosia	presence or absence of Ankilloglosia	2 weeks
Secondary	type of short frenulum	One of the anatomical classification of the lingual frenulum is that of Coryllos, which classifies the lingual frenulum depending on its proximity to the lingual apex, based on 4 types	2 weeks