Status:
COMPLETED
Analgesia in Lingual Frenulotomy in the Newborn
Lead Sponsor:
IRCCS Burlo Garofolo
Conditions:
Frenulum Breve
Eligibility:
All Genders
1-10 years
Phase:
NA
Brief Summary
Ankyloglossia (tongue-tie) is a congenital anomaly characterized by a short lingual frenulum that limits the physiological tongue movement and occurs with an estimated prevalence between 4 and 10% of ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Term newborns (37 - 41 weeks of gestational age) within the first 10 days of life;
- Birth weight ≥ 2500 grams;
- Presence of ankyloglossia;
- Indication to the frenulotomy according to the Hazelbaker Assessment Tool for Lingual Frenulum Function (HATLFF): anatomical-functional evaluation with a score lower than 8.
- Exclusion Criteria:
- Syndromic diagnosis (genetic/hereditary);
- Pathology of main organ (heart disease, brain disease etc.);
- Drugs intake that may interfere with the collected data (sedatives).
Exclusion
Key Trial Info
Start Date :
September 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04440462
Start Date
September 18 2020
End Date
December 31 2024
Last Update
May 7 2025
Active Locations (1)
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1
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Trieste, Trieste, Italy, 34137