Eligibility Criteria, Diagnosis and Degree of Tongue Tie
Q. We would automatically refer babies with a severe tongue-tie for frenotomy. However your eligibility criteria state any score of tongue-tie is eligible. Are we able to take part in the trial if we do not recruit babies with the most severe tongue-tie?
Q. We would not usually refer babies with very mild tongue-tie, or ambiguous tongue-tie, to frenotomy as our experience suggests breastfeeding support is most appropriate. We would find it hard to recruit babies with only mild tongue tie. However your eligibility criteria do not fit with our local policy, as you include all babies. Can we still take part?
There is no agreement over which is the best diagnostic tool to measure a baby’s degree of tongue-tie. Hospitals across the UK have different thresholds regarding what babies should be referred for a frenotomy, and which babies shouldn’t. So what counts as a “severe tongue-tie” might be interpreted differently by different hospitals. Some hospitals might use a score based on a diagnostic tool, while others do not use a score – they might instead consider babies who have been given a high amount of breastfeeding support over a number of weeks but are still struggling. As it stands, both of these approaches may be correct – because there is a lack of sufficient robust evidence around what tool to use, and what criteria for tongue-tie degree/severity to use, and under what circumstances a frenotomy works. Therefore, we have designed a pragmatic trial that will enable us to factor in these different thresholds, and recruit babies with varying degrees of tongue-tie across different centres.
Any baby who would qualify as eligible for a frenotomy according to your local policy, is eligible to join the trial.
If there is a genuine clinical need for a frenotomy, whereby you think withholding it would be detrimental to the baby’s health, then do not recruit.
If on assessment, a frenotomy would not be suitable for this baby according to your local criteria (e.g. if the need for tongue-tie division is questionable or it would be unnecessarily invasive), then do not recruit.
Q. Have you an agreed assessment tool?
Babies judged to have tongue-tie according to your usual local criteria are eligible for the trial. You can use your usual assessment in order to determine if an infant is eligible. Once the baby is randomised into the trial, the BTAT (Bristol Tongue-tie Assessment Tool) will be used and recorded. This will provide a consistent score for all participants entered into the trial.
Q. Why have you chosen the BTAT assessment tool?
It is a simple tool that is easy to perform in a busy clinic setting
It maps well onto other more detailed diagnostic tools, such as the Hazelbaker ATLFF tool
It is used to provide a consistent score across participants once they enter into the trial, but it is not used to diagnose tongue-tie in order to assess eligibility (unless this is the tool you usually use). Diagnosis and eligibility assessment should be done using your usual local criteria.
Q. What technique, or equipment for division do you recommend? What surgical technique will be used by all Trusts?
Trusts vary in the technique they use to divide tongue-ties, and technique may even vary between practitioners within the same trust. Therefore, we are not specifying that this should be done in one particular way. Divisions should be done according to your local preference. We will record the technique that is used for each participant.
Follow-Up and Type of Breastfeeding Support
Q. Will the follow-up visit be at the recruiting site or in their local area? Can community midwives and health visitors carry out the follow-up?
The follow-up visit does not need to occur at the recruiting site and can be carried out in the community, if this is your usual breastfeeding support provision. We will however need to know that the follow-up visit is taking place. We will discuss with sites in advance regarding their follow-up visit provision.
Q. We do not do a follow-up at 1-2 weeks post-frenotomy. Can we still take part?
It is important that a follow-up appointment takes place at 1 – 2 weeks after the baby was randomised to the trial. However, if follow-up appointments are not part of your usual provision, here are some suggestions how this can be delivered:
Bringing in those trial participants specifically for a face-to-face visit (as it will only be 2-3 per month, some sites have suggested this is manageable for trial participants).
Offering a telephone follow-up at 1 – 2 weeks after enrolment with the option of an immediate face-to-face visit/assessment at short notice if required
The follow-up support visit could be undertaken through e.g. community midwife service, as long as we know the women and babies would be getting adequate breastfeeding support and you can check that this visit takes place.
Q. What level of qualification should the person offering breastfeeding support have? Should they be IBCLC certified?
There is no level of qualification we specify, and we do not require staff to be IBCLC certified – we just specify that it should be your usual support.
We have set a minimum level of support available – it should include a minimum of: an initial face-to-face assessment of breastfeeding, for example using the LATCH tool or BFI assessment tool, and advice on positioning and attachment and at least one follow-up visit, together with drop-in clinic advice as required, but available on more than one day a week.
It was necessary to be flexible with this because of the variance across the UK in breastfeeding support provision (in some areas sadly there is none at all). We will be asking parents at 3 months how much breastfeeding support they accessed.
Weighing Facilities and Other Site Specifics
Q. We currently have scales in the treatment room but it will be very upsetting for the baby to be stripped off and weighed prior to the procedure. Does it need to be done on the day?
The baby’s weight can be recorded at any point in the week prior to the procedure, as long as it is a weight measurement taken in clinic (so that it is an accurate measurement).
Q. How many divisions would participant centres need to do to be part of the trial?
We would expect sites to recruit 2-3 participants to the trial per month, or more if capacity allows. The amount of referrals and frenotomies your site performs per month does not preclude your participation as a recruiting site.
Q. Are they going to be blinded or masked randomisations/divisions?
No. The trial originally had a blinded design where parents and trial staff did not know whether babies had received a frenotomy or not. However, for practical reasons, the trial moved to an unblinded design in August 2019.
Q. Why have you stopped attempting a masked study design?
The study is a piece of research commissioned by the NIHR (National Institute of Health Research). They expected the study to investigate the feasibility of masking, but as it has progressed, they were concerned that it was making it difficult to recruit babies to the trial, and so recommended it be removed in order that the trial has the best chance of recruiting enough participants.
Repeat Frenotomy/Requests For Frenotomy in Control Group
Q. If a parent on the trial requests a frenotomy or repeat frenotomy, what should we do?
At any stage after the FROSTTIE procedure, the baby should be assessed and managed based on their clinical need, there and then. If at any point they are deemed to need a frenotomy (e.g. because their clinical wellbeing depends on it), then this does not affect their participation in the trial. A baby’s clinical wellbeing is the most important thing.
If a parent requests a frenotomy, we advise you to deal with this as you would regardless of whether they are in the trial. If clinically it is felt that a frenotomy is needed, this is fine.
Q. What is the time limit for having a frenotomy in the control group (no-frenotomy)?
Our primary outcome is breastfeeding at 3 months of age. If at any stage a baby is referred again and deemed to need a frenotomy, clinical necessity is always the most important thing.
Q. What about if a parent of a baby in the control group goes elsewhere for a private frenotomy?
We will collect data from them to ask if this has happened.
The purpose of a follow-up visit at 1 – 2 weeks (rather than the next day, for example) is to give adequate time for breastfeeding support, to try and mitigate against this.
Q. If a baby in the control (no frenotomy) group has a frenotomy, or if a baby has a repeat frenotomy, does that mean they are no longer in the trial?
No. Baby will remain in the trial until 6 months, unless the parent withdraws consent to provide data. We will be collecting data on repeat frenotomy/requests for frenotomy in the control arm as part of our standard data collection.
Who Can Do Things on The Trial
Q. Who does that principal investigator have to be? Do you want a Consultant PI or can Midwives be PI for this study?
The PI can be a consultant, other doctor or midwife. They can be any person deemed suitability qualified in accordance with your trust’s R&D policy. We require the PI and the lead research nurse/midwife to be GCP trained.
Q. Who can randomise participants?
Anyone delegated to do so by the local PI. This person must be on the delegation log prior to randomisation, and have carried out training to use the NPEU’s randomisation website.
Q. Who can perform the frenotomy?
Anyone who is delegated to by the local PI.
Q. Who can consent participants?
Anyone who is delegated to by the local PI. They should have valid and up to date GCP training in order to consent participants. They must also be on the delegation log prior to taking consent.
Study support and ethical approval
Q. Is the trial ethical?
Yes. It has been approved by the National Research Ethics Service (REC – South Central Oxford B, ref. 18/SC/0580), to be carried out in participating NHS sites in the UK.
Q. Is the study on the NIHR portfolio?
The study is a CRN portfolio adopted study under maternal and reproductive health, with a sub-specialty of children’s health, so regional and local CRN research support is available.
Q. Will there be any direct funding for nurses on the trial?
No. However, the study has been adopted onto the CRN portfolio and is therefore eligible for support through regional CRN research nurses and midwives.
For any further questions or information, please contact the FROSTTIE team on 01865 617919 or email firstname.lastname@example.org