Condition category
Pregnancy and Childbirth
Date applied
04/02/2019
Date assigned
15/02/2019
Last edited
15/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
This is a study for babies with breastfeeding difficulties who are thought to have tongue-tie. 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. It is usually carried out as an outpatient by either a midwife or doctor and babies typically go home the same day. However, there are other reasons for breastfeeding difficulties, including poor positioning and attachment of the baby to the breast. These difficulties can be solved by support from skilled infant feeding counsellors, and it may be that being given this support is more useful to help mothers and babies to continue to breastfeed when the baby is thought to have a tongue-tie and an operation is not needed. The aim of this study is to see whether an operation makes a difference to mothers and their babies. The study will compare babies in the group who have the operation and breastfeeding support to babies in the group who only receive breastfeeding support but not an operation. The main outcome is to compare how many babies in each group are still breastfeeding at three months.

Who can participate?
Babies aged up to 10 weeks with breastfeeding difficulties diagnosed with a tongue-tie are eligible for inclusion, as long as their parents give consent to do so. Some babies will not be able to take part in the trial, for example babies born at less than 34 weeks’ gestation, or if they have a known bleeding disorder, or if they have another condition known to affect breastfeeding (e.g. cleft palate, Down syndrome).

What does the study involve?
After parents have been given information about the trial and decided that they would like their baby to take part, the baby is allocated at random (similar to tossing a coin) to either have an operation or not. All babies receive breastfeeding support whether or not they have an operation. When all the babies in the study are three months old, their mothers are asked whether they are still breastfeeding. Information is also collected about the age of the baby at his/her last breastfeed, the baby’s weight, any problems the baby had after the operation, whether the mothers have any breastfeeding difficulties e.g. pain or are anxious or depressed, and how confident they feel breastfeeding. This information is compared between the two groups to see if there are any differences 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. After six months, mothers are contacted again to see if they are still breastfeeding.

What are the possible benefits and risks of participating?
The findings will help guide care for women and their babies who are trying to breastfeed in the future. There are some risks associated with the frenotomy procedure. These include bleeding, a small risk of infection, and a small risk of salivary duct damage. However, both breastfeeding support and the frenotomy are standard care practices. Therefore the researchers do not believe there are any additional risks as a result of taking part in this study.

Where is the study run from?
The study is co-ordinated from the National Perinatal Epidemiology Unit Clinical Trials Unit (NPEU CTU), based at the University of Oxford. Participants will be recruited from 19 hospitals throughout the UK.

When is the study starting and how long is it expected to run for?
April 2018 to March 2021

Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (UK)

Who is the main contact?
Oliver Hewer
frosttie@npeu.ox.ac.uk

Trial website

www.npeu.ox.ac.uk/frosttie

Contact information

Type

Scientific

Primary contact

Prof Marian Knight

ORCID ID

http://orcid.org/0000-0002-1984-4575

Contact details

National Perinatal Epidemiology Unit
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom
-
marian.knight@npeu.ox.ac.uk

Type

Public

Additional contact

Mr Oliver Hewer

ORCID ID

Contact details

Trial Manager
National Perinatal Epidemiology Unit
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom
+44 (0)1865 617919
oliver.hewer@npeu.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

38654; HTA 16/143/01

Study information

Scientific 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

Acronym

FROSTTIE

Study hypothesis

To investigate whether frenotomy is clinically and cost effective to promote continuation of breastfeeding at three months in infants with breastfeeding difficulties diagnosed with tongue-tie.

Ethics approval

South Central - Oxford B Research Ethics Committee, The Health Research Authority, Whitefriars, Level 3, Block B, Lewin's Mead, Bristol, BS1 2NT, Tel: +44 (0)207 1048058, Email: nrescommittee.southcentral-oxfordb@nhs.net, 10/12/2018, REC ref: 18/SC/0580

Study design

Randomised; Interventional; Design type: Treatment, Process of Care, Management of Care, Surgery

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Tongue-tie

Intervention

The infants entered into the trial will be randomised 1:1 to either:
1. Frenotomy with standard breastfeeding support (intervention arm)
2. No frenotomy with standard breastfeeding support (comparator arm)

Intervention arm:
Infants who are eligible for the trial and whose parents consent for them to participate and who are randomised to frenotomy with breastfeeding support will undergo the procedure according to usual hospital practice. Frenotomy will be carried out by the usual trained practitioner for participating hospitals using their normal technique. Frenotomy is usually a quick procedure in which the tongue is lifted and the frenulum (the tissue between the underside of the tongue and the base of the mouth) is divided. Breastfeeding may be conducted immediately post-procedure, and the baby will undergo an immediate post-frenotomy observed feed. Parents will receive further advice on positioning and attachment together with standard post-frenotomy advice concerning bleeding and other post-frenotomy adverse events. Parents will be provided with details about how to access rapid breastfeeding support in the event of ongoing feeding difficulties and an appointment for at least one follow-up visit.

Comparator arm:
Infants who are eligible for the trial and whose parents consent for them to participate and who are randomised to breastfeeding support only will not undergo frenotomy, but at the frenotomy clinic will undergo an immediate observed feed and will receive further advice on positioning and attachment together with standard post-frenotomy advice concerning bleeding and other post-frenotomy adverse events. Parents will be provided with details about how to access rapid breastfeeding support in the event of ongoing feeding difficulties and an appointment for at least one follow-up visit.

The study will compare how many babies are still breastfeeding at aged 3 months in the two groups, and 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. The trialists will also ask the mothers to complete short questionnaires through a secure web-based data collection platform, or by post or phone if preferred.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Any breastmilk feeding at 3 months according to maternal self-report, defined as any breastmilk feeding in the 24 hours prior to the infant reaching three months of age. A positive response is indicative of continuation of breastfeeding.

Secondary outcome measures

Measured by specific question unless noted, at first follow-up visit and 3 months of age:
1. Mother’s pain while feeding during the previous 24 hours
2. Exclusive breastmilk feeding
3. Exclusive direct breastfeeding
4. Frenotomy in comparator group
5. Repeat frenotomy
6. Bleeding (following frenotomy or frenulum tear)
7. Post-procedure adverse events (tongue cut, scarring, salivary duct damage)
8. Maternal anxiety and depression dimension of EQ-5D-5L
9. Maternal health-related quality of life measured using EQ-5D-5L

Measured by specific question unless noted, at 3 months of age:
1. Mother’s breastfeeding self-efficacy, measured using Breastfeeding Self-Efficacy Scale – Short Form
2. Amount of breastfeeding support used, measured by total number of contacts with any breastfeeding supporter since the FROSTTIE procedure (whether face to face, or by telephone)
3. Infant weight gain from birth
4. Infant post-randomisation weight gain
5. Age of child when s/he last received breastmilk
6. Time spent breastfeeding in previous 24 hours
7. Maternal health-related quality of life, measured using EQ-5D-5L
8. Maternal and infant NHS healthcare resource use

Measured by specific question at 6 months:
1. Any breastmilk feeding

Overall trial start date

01/04/2018

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Infant aged less than 10 weeks referred (by parent or other breastfeeding support service) to an infant feeding service with breastfeeding difficulties and judged to have tongue-tie
2. Parent has given informed consent for participation

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Planned Sample Size: 870; UK Sample Size: 870

Participant exclusion criteria

1. Infants who have breastfeeding difficulties but are not judged to have tongue-tie
2. Babies born at less than 34 weeks’ gestation
3. Babies with a congenital anomaly known to interfere with breastfeeding e.g. cleft palate, Down syndrome
4. Babies with a known bleeding diathesis

Recruitment start date

01/01/2019

Recruitment end date

31/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Royal Albert Edward Infirmary
Wigan Lane
Wigan
WN1 2NN
United Kingdom

Trial participating centre

Royal Cornwall Hospital
Treliske
Truro
TR1 3LJ
United Kingdom

Trial participating centre

Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom

Trial participating centre

George Eliot Hospital
College Street
Nuneaton
CV10 7DJ
United Kingdom

Trial participating centre

Homerton University Hospital
Homerton Row
London
E9 6SR
United Kingdom

Trial participating centre

Milton Keynes University Hospital
Standing Way Eaglestone
Milton Keynes
MK6 5LD
United Kingdom

Trial participating centre

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance Team (CTRG)
Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
-
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/143/01

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol and other study documents will be made available on the website https://www.npeu.ox.ac.uk/frosttie

The trialists will submit for publication in a high impact peer-reviewed journal. They aim to present findings to academic and professional audiences at key conferences. They will also bring the trial results to the attention of the Cochrane review authors so that they may be considered for inclusion in an updated review.

It is NPEU policy to send results to all trial participants, unless they have opted out. The trialists will also share the results with other breastfeeding mothers through national organisations working to support breastfeeding, appropriate websites, social and traditional media as well as with organisations designing services and guidelines about breastfeeding and tongue-tie to help make sure that the services provided in the NHS are based on what they have found.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/03/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/02/2019: Trial’s existence confirmed by NIHR.