Randomised controlled trial of early frenotomy in breastfed infants with mild-moderate tongue-tie

Arch Dis Child Fetal Neonatal Ed. 2014 May;99(3):F189-95. doi: 10.1136/archdischild-2013-305031. Epub 2013 Nov 18.


Trial design: A randomised, parallel group, pragmatic trial.

Setting: A large UK maternity hospital.

Participants: Term infants <2 weeks old with a mild or moderate degree of tongue-tie, and their mothers who were having difficulties breastfeeding.

Objectives: To determine if immediate frenotomy was better than standard breastfeeding support.

Interventions: Participants were randomised to an early frenotomy intervention group or a 'standard care' comparison group.

Outcomes: Primary outcome was breastfeeding at 5 days, with secondary outcomes of breastfeeding self-efficacy and pain on feeding. Final assessment was at 8 weeks; 20 also had qualitative interviews. Researchers assessing outcomes, but not participants, were blinded to group assignment.

Results: 107 infants were randomised, 55 to the intervention group and 52 to the comparison group. Five-day outcome measures were available for 53 (96%) of the intervention group and 52 (100%) of the comparison group, and intention-to-treat analysis showed no difference in the primary outcome-Latch, Audible swallowing, nipple Type, Comfort, Hold score. Frenotomy did improve the tongue-tie and increased maternal breastfeeding self-efficacy. At 5 days, there was a 15.5% increase in bottle feeding in the comparison group compared with a 7.5% increase in the intervention group. After the 5-day clinic, 44 of the comparison group had requested a frenotomy; by 8 weeks only 6 (12%) were breastfeeding without a frenotomy. At 8 weeks, there were no differences between groups in the breastfeeding measures or in the infant weight. No adverse events were observed.

Conclusions: Early frenotomy did not result in an objective improvement in breastfeeding but was associated with improved self-efficacy. The majority in the comparison arm opted for the intervention after 5 days.

Keywords: Infant Feeding; Neonatology; Nutrition.

Publication types

  • Comparative Study
  • Pragmatic Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Ankyloglossia
  • Breast Feeding*
  • Feasibility Studies
  • Female
  • Humans
  • Infant, Newborn
  • Lingual Frenum / surgery*
  • Male
  • Midwifery / methods
  • Mothers
  • Mouth Abnormalities / surgery*
  • Pain Measurement
  • Postoperative Complications
  • Qualitative Research
  • Surveys and Questionnaires