Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.
Ankyloglossia, Breast Feeding, Enlarged Labial Frenum
About this trial
This is an interventional treatment trial for Ankyloglossia
Eligibility Criteria
Inclusion Criteria:
- Newborn is full term (at least 37 weeks) and otherwise in good health.
- Newborn exhibits having ankyloglossia (score of less than 11 with failing lactation management or an appearance score lower than 8, based on HATLFF) and a Class III or Class IV maxillary lip-tie, simultaneously.
- Mother of newborn noted to have nipple pain or difficulty with breastfeeding (LATCH score of <7).
- Mother of newborn has intention to exclusively breastfeed newborn.
- Mother of newborn signs a written informed consent for treatment.
Exclusion Criteria:
- Premature newborns.
- Newborns older than 2 weeks.
- Newborns with craniofacial anomalies (i.e. cleft lip or palate).
- Newborns who are neurologically compromised.
- Mother has condition that could affect the milk supply (i.e diabetes).
- Mother of newborn is not English speaking and not able to read at least at a 6th grade level.
Sites / Locations
- Tampa General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A
Group B
All participants will receive both the lingual frenotomy and sham procedure. Group A infants will receive lingual frenotomy for intervention #1 and a sham procedure for intervention #2. Newborns that continue to have difficulty with breastfeeding after both interventions will undergo intervention #3, a labial frenotomy. Lingual frenotomy: tongue will be elevated, expose frenulum with a grooved director or 2 cotton tipped applicators, and then incise frenulum tissue with a straight scissor. Sham/placebo procedure: infant brought into a procedure room and kept there for as long as the average experimental procedure would take (~5 minutes). Maxillary labial frenotomy: 0.1 ml of 1% lidocaine will be injected into the area, upper lip lifted, frenum stretched, and a laser, (iLaseTM 940 ± 15 nm) or scissors, will be used to release its attachment to the level of the periosteum.
All participating infants will receive both the lingual frenotomy and sham procedure. Group B infants will receive the sham procedure for intervention #1 and a lingual frenotomy for intervention #2. Newborns that continue to have difficulty with breastfeeding after both interventions will undergo intervention #3, a labial frenotomy. Sham/placebo procedure: infant brought into a procedure room and kept there for as long as the average experimental procedure would take (~5 minutes). Lingual frenotomy: tongue will be elevated, expose frenulum with a grooved director or 2 cotton tipped applicators, and then incise frenulum tissue with a straight scissor. Maxillary labial frenotomy: 0.1 ml of 1% lidocaine will be injected into the area, upper lip lifted, frenum stretched, and an iLaseTM 940 ± 15 nm laser used to release its attachment to the level of the periosteum.