FROSTTIE

A randomised controlled trial of FRenotomy and breastfeeding support Or breastfeeding Support without frenotomy to investigate continuation of breastfeeding for babies with Tongue-TIE

Trial started: 2018  Trial ended: 2021 

Summary

Objectives

To investigate whether frenotomy is clinically and cost-effective in promoting continuation of breastfeeding at 3 months in infants with breastfeeding difficulties diagnosed with tongue-tie.

Methods

A multicentre, unblinded, randomised, parallel-group controlled trial conducted in 12 infant feeding services in the UK. Infants aged up to 10 weeks referred to an infant feeding service with breastfeeding difficulties and judged to have tongue-tie were randomly allocated to frenotomy with standard breastfeeding support or standard breastfeeding support without frenotomy.

Outcome measures

Primary outcome: Any breastmilk feeding at 3 months according to maternal self-report. Secondary outcomes: Mother’s pain, exclusive breastmilk feeding, exclusive direct breastfeeding, frenotomy, adverse events, maternal anxiety and depression, maternal and infant NHS health-care resource use, cost-effectiveness, and any breastmilk feeding at 6 months of age.

Results

Between March 2019 and November 2020, 169 infants were randomised, 80 to the frenotomy with breastfeeding support arm and 89 to the breastfeeding support arm, from a planned sample size of 870 infants. The trial was stopped in the context of the COVID-19 pandemic because of withdrawal of breastfeeding support services, slow recruitment and crossover between arms. In the frenotomy with breastfeeding support arm, 74/80 infants (93%) received their allocated intervention, compared with 23/89 (26%) in the breastfeeding support arm. Primary outcome data were available for 163/169 infants (96%). There was no evidence of a difference between the groups in the rate of breastmilk feeding at 3 months, which was high in both groups [67/76 (88%) vs 75/87 (86%); adjusted risk ratio 1.02, 95% confidence interval 0.90 to 1.16]. Adverse events were reported for three infants after surgery [bleeding (n = 1), salivary duct damage (n = 1), accidental cut to the tongue and salivary duct damage (n = 1)]. Cost-effectiveness could not be determined with the information available.

Conclusions

This trial does not provide sufficient information to assess whether frenotomy in addition to breastfeeding support improves breastfeeding rates in infants diagnosed with tongue-tie.

Adapted from: Knight M, Ramakrishnan R, Ratushnyak S, et al. Frenotomy with breastfeeding support versus breastfeeding support alone for infants with tongue-tie and breastfeeding difficulties: the FROSTTIE RCT. Health Technology Assessment. 2023;27(11). https://doi.org/10.3310/WBBW2302. Licensed under the Creative Commons Attribution 4.0 International (CC BY 4.0) Licence (https://creativecommons.org/licenses/by/4.0/). Adapted for presentation on this website