Topic: Generic Health Relevance and Cross Cutting Themes
Conditions
Interventions
These babies will be randomised to Frenotomy (incision of the frenulum of the tongue in a tongue tied infant) at day 0 or day 5. They will be assessed using the LATCH tool (primary outcome). The Hazel
Sponsors
Southmead Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Term born infants with a functionally significant tongue tie (Hazelbaker Assessment Tool for Lingual Frenulum Function [HATLFF] score between 6-12) with breast feeding difficulties (LATCH score <-8) 2. Male and female participants 3. Upper Age Limit is 14 days
Exclusion criteria
Exclusion criteria: 1. Preterm infants 2. Infants with serious congenital anomalies 3. Infants who have lost >10% of their birth weight unless found to be well enough after checking by a neonatologist 4. Infants with a HATLFF score of <6, and those over 2 weeks old will be excluded from the study 5. Mothers who do not want their baby to have surgery 6. Babies that have not received vitamin K soon after birth, unless the mother agrees to an injection of vitamin K one hour before entering the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LATCH score, measured pre and post frenotomy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bresat feeding duration measured 8 weeks post procedure 2. HASLIFF score measured pre and post frenotomy 3. Maternal pain on breast feeding Likert scale measured pre and post frenotomy | — |
Countries
United Kingdom
Outcome results
None listed