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

摘要: Trial design A randomised, parallel group, pragmatic trial. Setting 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 randomised to an early intervention group ‘standard care’ comparison group. Outcomes Primary outcome at 5 days, secondary outcomes self-efficacy pain on feeding. Final assessment 8 weeks; 20 also had qualitative interviews. Researchers assessing outcomes, but not participants, blinded assignment. Results 107 55 the 52 group. Five-day measures available for 53 (96%) (100%) intention-to-treat analysis showed no difference in primary outcome— L atch, udible swallowing, nipple T ype, C omfort, H score. Frenotomy did improve tongue-tie increased maternal self-efficacy. At there 15.5% increase bottle feeding compared 7.5% group. After 5-day clinic, 44 requested frenotomy; by 8 weeks only 6 (12%) without frenotomy. 8 weeks, differences between groups infant weight. No adverse events observed. Conclusions Early result objective improvement associated improved The majority arm opted after 5 days.