FROSTTIE: A randomised controlled trial of FRenotomy Or breastfeeding Support for babies with Tongue-TIE
IRAS reference: 235355
REC reference: 18/SC/0580 (South Central Research Ethics Committee - Oxford B)
ISRCTN: 10268851 (https://doi.org/10.1186/ISRCTN10268851)
Clinical Trials Unit: NPEU Clinical Trials Unit
Sponsor: University of Oxford
Funding body: NIHR Health Technology Assessment (HTA) programme (16/143/01)
Chief Investigator: Professor Marian Knight | NIHR Professor of Maternal and Child Population Health | NPEU, University of Oxford
About the trial
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.
For further details please see the About FROSTTIE page.
The study is currently selecting recruiting sites.
If you are able to provide or facilitate infant feeding support services, with a minimum breastfeeding support level of:
- Initial face-to-face assessment of breastfeeding;
- Advice on positioning and attachment;
- At least one follow-up visit, together with drop-in clinic advice as required, but available on more than one day a week;*
- A standard follow-up visit at 1-2 weeks after frenotomy;*
Your site may be able to take part in this study. *Please note follow-up visits do not necessarily have to take place at your trust for you to take part.
Further details are available from:
NPEU Clinical Trials Unit | University of Oxford | Old Road Campus | Oxford OX3 7LF