FROSTTIE: A randomised controlled trial of FRenotomy Or breastfeeding Support for babies with Tongue-TIE
- REC Reference:
- Clinical Trials Unit:
- National Perinatal Epidemiology Unit CTU
- University of Oxford
- NIHR Health Technology Assessment (HTA) Programme
- Recruitment Target:
- Duration of Study:
- April 2018 - March 2021
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.
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 information is available by contacting Oliver Hewer or Madeleine Hurd.