FROSTTIE
Research type
Research Study
Full title
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
IRAS ID
235355
Contact name
Marian Knight
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Clinicaltrials.gov Identifier
21, UKCRC registration number
Duration of Study in the UK
5 years, 5 months, 30 days
Research summary
Research Summary
Many mothers and babies experience difficulties in starting 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, called a frenotomy, to release the tongue-tie by dividing this piece of skin under the tongue.
Currently, we do not know if this operation helps mothers and their babies to continue breastfeeding, or whether breastfeeding support alone is what they need. To answer this question we will compare babies given breastfeeding support with babies who have had breastfeeding support and have also had a frenotomy.
We will include 870 babies, of which 435 will be randomly allocated to receive just breastfeeding support, and 435 allocated to receive breastfeeding support and frenotomy. We will compare how many babies are still breastfeeding at aged three months in the two groups. We will also look at the level of breastfeeding, the support provided, any further surgery on the tongue-tie and the mother’s quality of life and perceptions of the level of breastfeeding of their baby. Information will be collected from the medical records by the clinical research team at the feeding support hospitals. We will also ask the mothers to complete short questionnaires through a secure web-based data collection platform, or by post or phone if preferred. The findings of this study will help guide care for women and their babies who are trying to breastfeed in the future.
Summary of Results
"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. 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.
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).
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."
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0580
Date of REC Opinion
13 Dec 2018
REC opinion
Further Information Favourable Opinion