A randomised controlled trial of frenotomy or breastfeeding support for babies with tongue-tie
| ISRCTN | ISRCTN10268851 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10268851 |
| Secondary identifying numbers | 38654; HTA 16/143/01 |
- Submission date
- 04/02/2019
- Registration date
- 15/02/2019
- Last edited
- 26/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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 about 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 around 22 hospitals throughout the UK.
When is the study starting and how long is it expected to run for?
April 2018 to May 2021
Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (UK)
Who is the main contact?
Victoria Stalker
frosttie@npeu.ox.ac.uk
Contact information
Scientific
National Perinatal Epidemiology Unit
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom
 ORCID ID |
0000-0002-1984-4575 |
|---|---|
| marian.knight@npeu.ox.ac.uk |
Public
Trial Manager
National Perinatal Epidemiology Unit
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom
| Phone | +44 (0)1865 617919 |
|---|---|
| frosttie@npeu.ox.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Process of Care, Management of Care, Surgery |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study 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(s) | 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 |
| 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. Previous 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. Current comparator arm as of 16/09/2019 (amended with protocol dated 28/06/2019): 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. 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 |
| 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) Updated 16/09/2019 (amended with protocol dated 28/06/2019): Amount of breastfeeding support used, measured by total number of contacts with any breastfeeding supporter since the infant joined the trial (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 study start date | 01/04/2018 |
| Overall study end date | 13/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Planned Sample Size: 870; UK Sample Size: 870 |
| Total final enrolment | 169 |
| 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 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 Added 16/09/2019 (amended with protocol dated 25/03/2019): 5. Infant has had a frenotomy prior to recruitment |
| Recruitment start date | 01/01/2019 |
| Recruitment end date | 27/11/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Newcastle upon Tyne
NE1 4LP
United Kingdom
Norwich
NR4 7UY
United Kingdom
Wigan
WN1 2NN
United Kingdom
Truro
TR1 3LJ
United Kingdom
Reading
RG1 5AN
United Kingdom
Nuneaton
CV10 7DJ
United Kingdom
London
E9 6SR
United Kingdom
Bradford
BD9 6RJ
United Kingdom
Leeds
LS1 3EX
United Kingdom
Casterton Avenue
Burnley
BB10 2PQ
United Kingdom
Swindon
SN3 6BB
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Carlisle
Cumbria
CA2 7HY
United Kingdom
Darlington
DL3 6HX
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Durham
DH1 5TW
United Kingdom
Blackburn
BB2 3HH
United Kingdom
Dudley
DY1 2HQ
United Kingdom
Worcester
WR5 1DD
United Kingdom
Manchester
M13 9WL
United Kingdom
Aylesbury
HP21 8AL
United Kingdom
Sponsor information
University/education
Clinical Trials and Research Governance Team (CTRG)
Joint Research Office
Block 60, Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
England
United Kingdom
| ctrg@admin.ox.ac.uk | |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 13/03/2020: 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. The triallists will also submit the protocol for publication. 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 plan | A statement on the management of participant data sharing can be found at https://npeu.ox.ac.uk/ctu/privacy-notice Previous 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v5 | 29/07/2020 | 06/01/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 25/07/2023 | 26/07/2023 | Yes | No |
Additional files
- ISRCTN10268851_PROTOCOL_v5_29Jul2020.pdf
- Uploaded 06/01/2021
Editorial Notes
26/07/2023: Publication reference added.
07/12/2022: The intention to publish date was changed from 31/12/2022 to 30/06/2023.
11/04/2022: The intention to publish date has been changed from 31/03/2023 to 31/12/2022
09/03/2022: The intention to publish date has been changed from 31/03/2022 to 31/03/2023.
25/05/2021: The overall trial end date has been changed from 14/05/2021 to 13/05/2021.
06/01/2021: The following changes have been made:
1. The overall trial end date has been changed from 30/04/2021 to 14/05/2021 and the plain English summary has been updated accordingly.
2. Uploaded protocol version 5.0, 29 July 2020 (not peer reviewed).
01/12/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2020 to 27/11/2020.
2. Recruitment resumed as of June 2020.
3. The overall trial end date has been changed from 31/03/2021 to 30/04/2021.
4. The final enrolment number has been added.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused.
13/03/2020: The following changes have been made:
1. The public contact has been updated.
2. The trial participating centre "Royal United Hospital " has been removed.
3. The trial participating centres "Russells Hall Hospital", "Worcestershire Royal Hospital", "Royal Manchester Children’s Hospital" and "Stoke Mandeville Hospital" have been added.
4. The publication and dissemination plan has been updated.
5. The plain English summary has been updated to reflect the changes above.
17/09/2019: Internal review.
16/09/2019: Contact details, interventions, secondary outcome measures, exclusion criteria, and trial participating centres were updated.
15/02/2019: Trial’s existence confirmed by NIHR.
