AnkyloglossiaNCT04703946
Incidence of Short Sublingual Frenulum in Newborns at the Hospital Nostra Senyora de Meritxell.
An observational study of Ankyloglossia, run by Universitat Internacional de Catalunya at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 2 weeksHealthy volunteers can take part
- Conditions the study is for
- Ankyloglossia
- What is being tested?
- observacional
- How many people
- 2,167 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 2 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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%.
Who may be able to join
- The inclusion criteria are patients born from July 2018 to February 2021 (both inclusive) and of both genders.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
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.
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.
Read the 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
- Being tested
- observacional
- Medical subject headings
- Ankyloglossia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observacionalOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankilloglosia
presence or absence of Ankilloglosia
Measured: 2 weeks
Secondary outcomes (1)
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start1 Jan 2018
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnkyloglossiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Guinot-Jimeno, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703946
- Sponsor's protocol ID
- UIC-ODP-ANDORRA
- Status last verified
- May 2021
- First submitted
- 8 Jan 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04703946
- Acronym / sponsor ID
- UIC-ODP-ANDORRA
- Conditions
- Ankyloglossia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,167 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 minute to 2 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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%.
Key inclusion criteria (1 listed)
- The inclusion criteria are patients born from July 2018 to February 2021 (both inclusive) and of both genders.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observacionalAnalyze 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. | Other | – |
Primary outcome
Ankilloglosia
Time frame: 2 weeks
presence or absence of Ankilloglosia
1 secondary outcome
type of short frenulum
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankyloglossia, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankilloglosia (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.