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FROSTTIE Trial Results

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

Sometime ago you and your baby took part in the FROSTTIE trial looking at breastfeeding support for babies with tongue-tie. Unfortunately the trial met with challenges due to the COVID-19 pandemic and had to stop sooner than we had planned. We are now in a position to share the findings with you and would like to thank you for contributing to this important area of research.

Why did we do this trial?

Many mothers and babies experience difficulties in establishing breastfeeding. In some babies it is thought that their difficulties may be linked to a condition called tongue-tie, in which a piece of skin tightly joins the middle part of the underside of the tongue to the base of the baby's mouth. This can be treated by an operation to divide the tight part/skin in the middle of the underneath of the tongue.

We planned to carry out a trial of 870 babies to find out whether an operation together with breastfeeding support helps more mothers and babies with tongue-tie to continue breastfeeding until the baby is 3 months old compared to breastfeeding support on its own and whether the costs were different between the two groups of mothers and babies.

What did we do?

The trial started recruiting in March 2019. However, we were only able to recruit 169 babies as the trial was stopped because of slow recruitment, changes to services in the COVID-19 pandemic and a high proportion of the babies in the breastfeeding support group going on to have an operation.

What did we find?

There were no differences in the rate of breastfeeding at 3 months between the babies in the group who had an operation straightaway and those in the group that had breastfeeding support alone, or had an operation later. More than four in every five babies in both groups were still breastmilk feeding at 3 months. Three babies who had an operation, around 1 in 50 babies, had a complication of the operation (bleeding, scarring or a cut to the tube that makes saliva).

What does this mean for babies with tongue-tie?

Because of the small size of the study, we cannot say whether an operation to divide a tongue-tie along with breastfeeding support helps babies with tongue-tie and breastfeeding difficulties or has different costs. We will need to try different types of research to answer the question.

You can read more about the findings of the FROSTTIE trial by visiting:

Updated: Wednesday, 20 December 2023 08:16 (v16)

Contact us

For more information about FROSTTIE, please view the contact details page