FROSTTIE

FROSTTIE: A randomised controlled trial of FRenotomy Or breastfeeding Support for babies with Tongue-TIE

Recruitment
Total
0013
Target
870

The latest infant was recruited at Royal Victoria Infirmary on 12 June 2019

REC Reference:
18/SC/0580
Clinical Trials Unit:
National Perinatal Epidemiology Unit CTU
Sponsor:
University of Oxford
Funder:
NIHR Health Technology Assessment (HTA) Programme
Recruitment Target:
870
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.

FROSTTIE Updates

See all updates

This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (Reference Number 16/143/01). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.