Ankyloglossia, Breastfeeding Support
Conditions
Keywords
tongue tie, breastfeeding, exercises, infant, pediatric otolaryngology, frenotomy
Brief summary
The goal of this randomized control trial is to determine the impact of post-frenotomy manual manipulation on revision rates and breastfeeding outcomes. We hypothesize that post-frenotomy manipulation will reduce the rate of sublingual frenulum regrowth, and subsequently frenotomy revision rates, thereby improving breastfeeding performance. Infants with ankyloglossia undergoing frenotomy will be randomized into two groups: the intervention group (post-frenotomy manipulation) and the control group (no intervention). Parents in the intervention group will be instructed to perform tongue stretching and suck re-training exercises four times daily for 2-3 weeks, beginning 24 hours post-procedure. To monitor adherence and assess any complications, investigators will conduct a follow-up phone call one week after the procedure. Parents in the control group will not be instructed to perform any post-procedural manipulation. All participants will have a mandatory in-person follow-up 2-3 weeks postoperatively, during which breastfeeding outcomes and the need for frenotomy revision will be evaluated.
Interventions
OTHERPost-frenotomy manual manipulation
Parents assigned to the treatment group will be instructed to perform post-frenotomy stretches and exercises four times daily, after every other feed, until the time of their postoperative visit 2-3 weeks later.
Sponsors
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 90 Days
Healthy volunteers
No
Inclusion criteria
* infants less than 90 days old with ankyloglossia who undergo outpatient frenotomy using cold-steel scissors and will be exclusively or partially breastfed.
Exclusion criteria
* infants older than 90 days, those who will be exclusively bottle fed, infants who undergo concomitant lip tie release, those who undergo laser frenotomy, and infants who have previously undergone a frenotomy. * infants with a gestational age of less than 36 weeks, those in the NICU or post-partum unit, infants who didn't receive the vitamin K injection, and those with congenital anomalies or medical conditions affecting breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of infants who are recommended to undergo repeat frenotomy | From enrollment to the 2-3 week postoperative visit | Recommendations for frenotomy revision will be made by the principal investigator during the post-operative visit, which occurs 2-3 weeks following the procedure. This will include a physical examination to assess post-operative healing, along with an evaluation of the mother's breastfeeding outcomes. |
| Improvement in breastfeeding performance following post-procedural manual manipulation | From enrollment to the 2-3 week postoperative visit | Pre- and post-operative maternal breastfeeding performance will be assessed using the LATCH score, a validated questionnaire that evaluates breastfeeding effectiveness. The pre-operative score will be administered during the initial consultation, while the post-operative score will be taken at the follow-up visit, 2-3 weeks after the procedure. The difference in scores will be analyzed to determine if there is an improvement in maternal breastfeeding outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance with post-frenotomy stretching and exercises | From enrollment to the 1 week postoperative phone call | Parents assigned to the treatment group will receive a phone call one week postoperatively to assess their adherence to the treatment plan. |
Countries
United States
Contacts
Primary ContactEmily A Clementi, BA
Outcome results
None listed