Efficacy of neonatal release of ankyloglossia: a randomized trial

Abstract

Background: Ankyloglossia has been associated with a variety of infant-feeding problems. Frenotomy commonly is performed for relief of ankyloglossia, but there has been a lack of convincing data to support this practice.

Objectives: Our primary objective was to determine whether frenotomy for infants with ankyloglossia improved maternal nipple pain and ability to breastfeed. A secondary objective was to determine whether frenotomy improved the length of breastfeeding.

Methods: Over a 12-month period, neonates who had difficulty breastfeeding and significant ankyloglossia were enrolled in this randomized, single-blinded, controlled trial and assigned to either a frenotomy (30 infants) or a sham procedure (28 infants). Breastfeeding was assessed by a preintervention and postintervention nipple-pain scale and the Infant Breastfeeding Assessment Tool. The same tools were used at the 2-week follow-up and regularly scheduled follow-ups over a 1-year period. The infants in the sham group were given a frenotomy before or at the 2-week follow-up if it was desired.

Results: Both groups demonstrated statistically significantly decreased pain scores after the intervention. The frenotomy group improved significantly more than the sham group (P < .001). Breastfeeding scores significantly improved in the frenotomy group (P = .029) without a significant change in the control group. All but 1 parent in the sham group elected to have the procedure performed when their infant reached 2 weeks of age, which prevented additional comparisons between the 2 groups.

Conclusions: We demonstrated immediate improvement in nipple-pain and breastfeeding scores, despite a placebo effect on nipple pain. This should provide convincing evidence for those seeking a frenotomy for infants with signficant ankyloglossia.

Trial registration: ClinicalTrials.gov NCT00967915.