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 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. Can we still take part?
It is important that a follow-up appointment takes place at 1 – 2 weeks. However, if this is not part of your usual provision, here are some suggestions how it 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 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?
Yes, at least for the pilot phase of the study (the first 9 months of recruitment). Parents should not witness the procedure directly. Ideally, the person performing the follow-up procedure should not be the same person as who performed the FROSTTIE procedure, and therefore will also be blinded/masked to the study intervention.
Q. Why are you attempting a masked study design?
There are numerous reasons, mostly to due to the potential for bias, both within the clinical community and participant population.
There is genuine uncertainty and disagreement about the effectiveness of frenotomy, and knowledge of the trial allocation might have an impact on the outcomes we are measuring.
There is a potential placebo effect of frenotomy.
The study is a piece of research commissioned by the NIHR (National Institute of Health Research), who have identified it as a research question of high importance to the NHS. Acknowledging these issues around bias and uncertainty, the NIHR expected the study to investigate the feasibility of masking.
Q. Who is masked in the study?
As far as possible, it is a double-blinded study, meaning the parents and follow-up staff members are masked to the trial allocation.
The only people in the study that are unmasked are the person performing the FROSTTIE procedure, and for safety reasons one staff member (outside of the trial team) within the NPEU.
The person performing the procedure can be the same person recruiting and randomising, however if possible they should not be the person who performs the follow-up visit.
Q. Will it work?
We are monitoring the feasibility of blinding for the first 9 months of recruitment (the pilot phase of the trial). We will ask parents directly if they become unmasked. If it is completely unfeasible or futile, then we will move to an unblinded study.
Q. Is it 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. How do you think we should attempt masking the procedure?
Babies will have an appointment to have the FROSTTIE procedure (either a frenotomy or no frenotomy). The only thing we are asking, is that parents do not directly witness the procedure. Some examples include the following, depending on your facilities and preference:
The mother/parents wait in a separate room (if they agree)
The mother/parents are in the same room but behind a curtain
They are shielded from view from one of the staff members carrying out the procedure
They look away
Q. When we assess babies, if they are suitable for frenotomy then we ask parents to sign our Trust's consent form, consenting to have the procedure done. How should we manage this with babies randomised to the non-frenotomy arm, as they won't be having a procedure?
If your Trust requires a consent form to be completed for surgery, please complete for infants on both arms. Write “FROSTTIE Procedure” if necessary to ensure parents are not unmasked.
Q. What about babies in the non-frenotomy arm? We would not feel comfortable carrying out an unnecessary invasive procedure, or to purposefully distress the baby or make them cry. What about the use of gauze or prescription of post-frenotomy medicines. How do you expect us to do this?
We are not expecting or asking sites to carry out any unnecessary or invasive procedures for babies on the control arm. All that we are asking, is that parents do not directly witness the procedure.
We would not therefore, expect you to use gauze; or to prescribe anaesthetics; or to make them cry for no reason.
Q. We teach mums to look for clinical signs after frenotomy. How can I give the parents post-care advice if it’s a masked study design? Will it not unmask them?
Parents can be given the standard frenotomy post-care literature, and told the clinical signs to look out for following frenotomy.
If there are clinical signs, and the parents think they have found out what arm their baby is in because of those clinical signs, then we will collect this data. We are monitoring the feasibility of a masked study design for the pilot (the first 9 months) and if it unfeasible we will move to an unmasked study design.
It shouldn’t really be any different to e.g. a drug trial with a placebo, whereby participants are told to look out for clinical signs associated with investigational products.
Q. At the follow-up visit, won’t the clinician/midwife/breastfeeding supporter become unmasked?
There is a possibility that the staff member may become unmasked, through physical examination of the baby’s mouth or other means.
It is not necessary to report it if the staff member becomes unmasked, but the staff member should not intentionally disclose whether or not a baby has had a frenotomy to the parents.
Q. What should we do if parents ask us about the trial arm at the follow-up visit?
The staff member should act with discretion and only inform the parent if there is a genuine clinical need to tell them in order to guide the baby’s clinical care.
Parents will have been told at consent, that it is a blinded study
You can explain that you could guess, but will not know for certain which group the baby is in.
Reassure them that you are advising them based on what you think is best for the baby now, regardless of what group they are in
In many cases, appropriate clinical management may be achieved by managing them as if they have received the frenotomy, e.g. providing standard post-frenotomy advice
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. Should we do another masked procedure?
Do not perform another masked procedure. At this stage, the parent and follow-up clinician will become unmasked.
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. However, this person should not be the same person who performs the follow-up visit.
Q. Who does the follow-up visit? Can it be the same person who does the frenotomy?
Ideally, the person performing the follow-up visit should be any person other than whoever performed the FROSTTIE procedure.
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.
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