Tongue-tie Pregnancy and Childbirth Ankyloglossia
Conditions
Interventions
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
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactVictoria Stalker
Outcome results
None listed