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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04703946
Other study ID # UIC-ODP-ANDORRA
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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