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
Funder: Department of Health and Social Care

Abstract: DESIGN: Multicentre (individually) randomised controlled trial. SETTING: Infant feeding support services TARGET POPULATION: Infants with breastfeeding difficulties judged to have tongue-tie. INCLUSION CRITERIA: any baby aged up to 10 weeks referred (by mother or other breastfeeding support service) to an infant feeding service with feeding difficulties and judged to have tongue tie. EXCLUSION CRITERIA: babies older than 10 weeks, or who have breastfeeding difficulties but are not judged to have tongue-tie, or who have a congenital anomaly known to interfere with breastfeeding or who have a known bleeding diathesis. HEALTH TECHNOLOGIES BEING ADDRESSED: Intervention: frenotomy with breastfeeding support. Frenotomy will be carried out by the usual trained practitioner for participating hospitals (midwife, ENT surgeon, paediatric surgeon) using their usual technique. Breastfeeding support will be the usual support provided by participating hospitals, to include a minimum of: an initial face to face assessment and at least one follow-up visit, and available access to drop-in clinic advice as required. Comparator: breastfeeding support only, as defined above. MEASUREMENT OF COSTS AND OUTCOMES: Primary outcome: Any breastmilk feeding at 3 months according to maternal self-report, defined as any breastmilk feeding in the 24h prior to the infant reaching three months of age. A positive response is indicative of continuation of breastfeeding. Secondary outcomes measured at 3 months: mother’s breastfeeding self-efficacy (Breastfeeding Self- Efficacy Scale – Short Form (Dennis 2003)), mother’s pain, amount of breastfeeding support used, infant weight gain, exclusive breastmilk feeding, exclusive direct breastfeeding, age of child when he/she last received breastmilk, time spent breastfeeding in previous 24h, request for frenotomy, repeat frenotomy, bleeding (following frenotomy or frenulum tear), post surgery adverse events (tongue cut, scarring, salivary duct damage), maternal anxiety or depression (anxiety and depression dimension of EQ-5D-5L), maternal health-related quality of life (EQ-5D-5L), maternal and infant NHS healthcare resource use. Secondary outcome measured at 6 months: any breastmilk feeding. SAMPLE SIZE: Assuming a 10% increase in the rate of breastfeeding represents the minimal clinically important difference, a breastfeeding rate of 70% in the control group, 90% study power and two-sided 5% level of significance, allowing for 5% loss to follow-up and 5% increase for contamination gives a sample size of 435 in each group, total 870. DIFFERENCE BETWEEN CURRENT AND PLANNED CARE PATHWAYS: Current care pathways include highly variable use of both frenotomy and breastfeeding support. The proposed trial will compare frenotomy with breastfeeding support to breastfeeding support only, specifying a minimum level of breastfeeding support. PROJECT TIMETABLES INCLUDING RECRUITMENT RATE: Planned duration 36m, recruitment 24m, recruiting 2 infants per centre per month (50% of eligible). Pre-trial: establish TMC and DMC; recruit trial staff. Months 1-4: obtain approvals; set-up study sites and begin recruitment. Months 30-36: Analysis, reporting and dissemination. EXPERTISE IN TEAM: Multicentre perinatal trials, infant feeding, neonatology, paediatric surgery, obstetrics, public health, statistics, health economics, lay support

Lay abstract: 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. Working with members of The Breastfeeding Network and actively breastfeeding mothers, we have designed a study to see whether an operation makes a difference to mothers and their babies. We plan to carry out a trial to find out whether an operation together with breastfeeding support helps more mothers and babies with tongue-tie to continue breastfeeding until the baby is three months old. We 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. After parents have been given information about the trial and decided that they would like their baby to take part, the baby will be allocated at random (similar to tossing a coin) to either have an operation or not. All babies will receive breastfeeding support whether or not they have an operation. Parents will not know whether their baby has had the operation. All babies will then continue to receive breastfeeding support either by telephone or face to face with their breastfeeding supporter. If any babies continue to have difficulties with breastfeeding, they will be invited back to the hospital clinic to be examined again and given further breastfeeding advice and support. Babies who still have feeding problems at this stage despite further advice and support may need to have an operation, regardless of which group they are in. When all the babies in the trial are three months old, we will ask their mothers whether they are still breastfeeding. We will also collect information 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. We will compare this information 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. When we have completed the research, we will share the results with the parents whose babies took part in the trial. We will also share it with other breast feeding mothers through national organisations working to support breastfeeding, appropriate web fora, 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 we have found.

Research activity codes: 6.4 SURGERY
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH