Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.

University of South Florida120 enrolled

Overview

We are proposing to conduct a randomized, controlled trial of newborns in the maternal infant care areas at Tampa General Hospital. Participants who are determined eligible for the study (classified to have ankyloglossia via the HATLFF and either a Class III or IV maxillary labial frenum) will be randomly assigned to one of two groups: Group A or Group B. Group A will receive a sham procedure for intervention #1 and a lingual frenotomy procedure for intervention #2. Group B will receive a lingual frenotomy procedure 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, and breastfeeding will be monitored afterwards.

The study is a randomized control studies which aims to contribute data to a previous study on the effects of ankyloglossia (tongue-tie) on breastfeeding, and to also provide new information on the effects of maxillary lip-tie on breastfeeding. Participants who are determined eligible for the study (classified to have ankyloglossia via the HATLFF and either a Class III or IV maxillary labial frenum) will be randomly assigned to one of two groups: Group A or Group B. Group A will receive a sham procedure for intervention #1 and a lingual frenotomy procedure for intervention #2. Group B will receive a lingual frenotomy procedure 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, and breastfeeding will be monitored afterwards. These results will be analyzed to determine when lingual frenotomies, labial frenotomies, or both are necessary to improve breastfeeding pain and LATCH scores. The study aims to prove that the simple and low risk frenotomy procedure should be considered as treatment for both ankyloglossia and maxillary lip-tie, preventing breastfeeding complications as well as many other future problems such as with speech and self esteem. It is hypothesized that the use of frenotomies as treatment for ankyloglossia and maxillary lip-tie will improve breastfeeding success for breastfeeding couplets with newborns with both ankyloglossia and maxillary lip-tie. It is expected to see an increase in LATCH score to \>7 for breastfeeding sessions and a significant decrease in scoring on the pain scale after frenotomy intervention, while it is expected to see little change in LATCH and pain scale assessment scores after sham procedures. Overall data is not expected to vary significantly between Group A and Group B. It is also hypothesized that a lingual frenotomy alone will be sufficient to improve breastfeeding success without the need to also conduct a labial frenotomy.

Interventions

Lingual FrenotomyPROCEDURE

For newborns receiving the ankyloglossia frenotomy, the tongue will be elevated and the frenulum exposed with a grooved director or 2 cotton tipped applicators. The frenulum tissue will then be incised with a straight scissor. If thick, it will be crushed with a straight clamp to provide anesthesia and decrease bleeding, and the exposed and previously clamped tongue frenulum will be incised with a straight scissor.

Labial FrenotomyPROCEDURE

For newborns receiving the maxillary labial frenotomy, 0.1 ml of 1% lidocaine will be injected into the area. The upper lip will be lifted and the frenum stretched. Then an iLaseTM 940 ± 15 nm laser will be used to release its attachment to the level of the periosteum.

Sham ProcedurePROCEDURE

Eligibility

Sex: ALLMax age: 2 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: 1. Newborn is full term (at least 37 weeks) and otherwise in good health. 2. 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. 3. Mother of newborn noted to have nipple pain or difficulty with breastfeeding (LATCH score of \<7). 4. Mother of newborn has intention to exclusively breastfeed newborn. 5. Mother of newborn signs a written informed consent for treatment. Exclusion Criteria: 1. Premature newborns. 2. Newborns older than 2 weeks. 3. Newborns with craniofacial anomalies (i.e. cleft lip or palate). 4. Newborns who are neurologically compromised. 5. Mother has condition that could affect the milk supply (i.e diabetes). 6. Mother of newborn is not English speaking and not able to read at least at a 6th grade level.

Outcomes

Primary Outcomes

Change in Wong-Baker FACES Pain Rating Scale

This visual pain analog scale is used to measure breastfeeding pain experienced by the mother.

Time frame: after breastfeeding before intervention #1, after breastfeeding after intervention #1, after breastfeeding after intervention #2, and during 1 week follow-up (also after intervention #3 if applicable)

Change in LATCH score

Latch, Audible swallowing, Type of nipple, Comfort, and Hold (LATCH) Breastfeeding Quality Assessment