Ankyloglossia (tongue-tie) in newborn infants requiring frenotomy, including breastfeeding difficulties associated with restricted tongue movement such as poor latch, maternal nipple pain, ineffective milk transfer, and inadequate weight gain. Ankyloglossia, Tongue-Tie, Frenotomy, Lingual Frenulum, Newborn Infant, Neonate, Breast Feeding, Breastfeeding Difficulties, Surgical Instruments, Medical Devices, Patient Safety, Feasibility Study
Conditions
Interventions
Gavin Tongue Retractor (Thai Petty Patent No. 24030002923), single-use sterile tongue retractor designed specifically for neonatal frenotomy. Manufactured from medical-grade polypropylene random copol
Experimental Device
Gavin Tongue Retractor
Sponsors
Chulabhorn Royal Academy
Eligibility
Sex/Gender
All
Age
4 Hours to 30 Days
Inclusion criteria
Inclusion criteria: 1. Neonates aged 0 to 30 days. 2. Gestational age at birth greater than 35 weeks. 3. Birth weight greater than 2,000 grams. 4. Diagnosed with ankyloglossia by physical examination and meeting at least one of the following criteria: 4.1 Hazelbaker Assessment Tool for Lingual Frenulum Function (HATLFF) function score less than 11. 4.2 HATLFF appearance score less than 8. 4.3 Siriraj Tongue Tie Score of 7 or lower. 4.4 Presence of clinical indications for frenotomy, including maternal nipple pain during breastfeeding, poor latch, ineffective breastfeeding, or inadequate infant weight gain. 5. Parent or legal guardian is able to understand the study information and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Neonates with congenital anomalies of the oral cavity, tongue, or craniofacial structures that may interfere with feeding or the frenotomy procedure. 2. Neonates with known or suspected bleeding disorders, coagulation abnormalities, or a family history suggestive of inherited bleeding disorders. 3. Neonates with any medical condition that, in the opinion of the investigator, would make participation in the study unsafe. 4. Parent or legal guardian declines or withdraws informed consent for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural success rate immediately after end of the intervention percent,Procedural duration immediately after end of the intervention seconds,Data completion rate 7 days after end of the intervention percent | — |
Secondary
| Measure | Time frame |
|---|---|
| Physician satisfaction score immediately after end of the intervention 5-point Likert scale,Change in maternal nipple pain score from baseline to immediately after frenotomy and at 24 hours post-procedure, Visual Analogue Scale (VAS),Change in LATCH Score before frenotomy, immediately after frenotomy, and 24 hours after the procedure LATCH Score,Repeat frenotomy rate 7 days after end of the intervention percent,Procedure-related complication rate with in 96 hours after end of the intervention percent | — |
Countries
Thailand
Contacts
Public ContactPaveewan Suttipongkeat
Chulabhorn Royal Academy
Outcome results
None listed