Post-Procedural Manual Manipulation for Infant Ankyloglossia

Официальное название

Effectiveness of Post-Procedural Manual Manipulation for Infant Ankyloglossia in Enhancing Breastfeeding and Reducing Revision Rates: A Prospective Randomized Trial

Обзор

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.

Вмешательства

• Другое Post-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.

Первичные конечные точки

• Proportion of infants who are recommended to undergo repeat frenotomy [Срок оценки: From enrollment to the 2-3 week postoperative visit]
• Improvement in breastfeeding performance following post-procedural manual manipulation [Срок оценки: From enrollment to the 2-3 week postoperative visit]

Вторичные конечные точки (1)

• Compliance with post-frenotomy stretching and exercises [Срок оценки: From enrollment to the 1 week postoperative phone call]

Критерии участия

Критерии включения

• infants less than 90 days old with ankyloglossia who undergo outpatient frenotomy using cold-steel scissors and will be exclusively or partially breastfed.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery — Washington D.C.

Публикации

• LeFort Y, Evans A, Livingstone V, Douglas P, Dahlquist N, Donnelly B, Leeper K, Harley E, Lappin S. Academy of Breastfeeding Medicine Position Statement on Ankyloglossia in Breastfeeding Dyads. Breastfeed Med. 2021 Apr;16(4):278-281. doi: 10.1089/bfm.2021.29179.ylf. No abstract available. PMID 33852342
• Messner AH, Walsh J, Rosenfeld RM, Schwartz SR, Ishman SL, Baldassari C, Brietzke SE, Darrow DH, Goldstein N, Levi J, Meyer AK, Parikh S, Simons JP, Wohl DL, Lambie E, Satterfield L. Clinical Consensus Statement: Ankyloglossia in Children. Otolaryngol Head Neck Surg. 2020 May;162(5):597-611. doi: 10.1177/0194599820915457. Epub 2020 Apr 14. PMID 32283998

Идентификаторы

NCT: NCT06830148 · STUDY00008313

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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