FROSTTIE is a multi-centred randomised trial for babies with breastfeeding difficulties who are thought to have tongue-tie and who are receiving breastfeeding support and there is uncertainty about whether frenotomy would help continuation of breastfeeding.
The aim of the trial is to find out if skilled support for breastfeeding on its own, or together with a frenotomy helps mothers and their babies to breastfeed.
Babies aged <10 weeks with breastfeeding difficulties diagnosed with a tongue-tie are eligible for inclusion, as long as the parents are willing to enter the trial and have the decision about frenotomy decided randomly. All babies will continue to receive breastfeeding support.
The main outcome is to measure how many babies in each group are still breastfeeding at three months. Information about other outcomes for mother and baby will also be collected at three months. At 6 months old, mothers will be contacted again for information about breastfeeding.
The trial team will undertake a subgroup analysis to examine the effect of frenotomy amongst babies who may be considered to have more and less severe tongue-tie.
The study is sponsored by the University of Oxford, and is run by the National Perinatal Epidemiology Unit, Clinical Trials Unit (NPEU CTU) at the University of Oxford.
The study is funded by the National Institute of Health Research, HTA programme (ref. 16/143/01).
It has been approved by South Central - Oxford B Research Ethics Committee (ref. 18/SC/0580), the Health Research Authority (HRA) and Health and Care Research Wales (HCRW).
For more information about the trial, please contact Oliver Hewer (FROSTTIE Trial Manager):