A trial of tongue-tie division and its immediate effect on breastfeeding
| ISRCTN | ISRCTN24575064 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24575064 |
| Protocol serial number | 120/01/t |
| Sponsor | Southampton University Hospitals NHS Trust (UK) |
| Funder | Southampton University Hospitals NHS Trust (UK) |
- Submission date
- 22/06/2011
- Registration date
- 15/07/2011
- Last edited
- 24/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Ankyloglossia, more commonly known as “tongue-tie”, is a common congenital (present from birth) condition which affects the way the tongue moves in the mouth. About 4% of children are born with this problem, in which the cord-like skin (frenulum) that joins the bottom of the tongue to the floor of the mouth is too short, limiting the tongue’s range of movement. In some cases, babies may have difficulties breastfeeding, as they are unable to open their mouths wide enough or to suck properly. This can lead to painful nipples for the mother, and can mean that the baby does not gain weight as it should. If feeding is affected, then a tongue-tie division procedure is recommended. This simple operation involves cutting the frenulum to allow the tongue to move. Tongue-tie division is often carried out when the child is a few months old, and afterwards the baby is able to feed normally straight away. It has been suggested that the fact that mothers report an immediate improvement in breastfeeding could be down to the placebo effect (that it works only because it is expected to). The aim of this study is to investigate the possibility that the reported improvements in breastfeeding are due to the placebo effect.
Who can participate?
Babies under four months of age with tongue-tie, who have difficulties with breastfeeding.
What does the study involve?
Participants are randomly allocated into two groups. Those in the first group receive the tongue-tie division procedure, and those in the second group did not receive the procedure. All infants are returned to their mothers with a square of gauze under their tongues so that the mothers do not know whether their child has had the procedure or not. Before and after the procedure, mothers are asked to feed their babies and to give their opinions on how well their child is feeding, and their level of pain.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Wessex Regional Centre for Paediatric Surgery (UK)
When is the study starting and how long is it expected to run for?
October 2003 to July 2004
Who is funding the study?
Southampton University Hospitals NHS Trust (UK)
Who is the main contact?
Mr Mervyn Griffiths
Contact information
Scientific
Wessex Regional Centre for Paediatric Surgery
Southampton General Hopital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre double-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A double-blind, randomised, controlled trial of tongue-tie division and its immediate effect on breastfeeding |
| Study objectives | That division of tongue-tie causes an immediate change in breastfeeding which the mother can detect and is not due to placebo effect |
| Ethics approval(s) | Southampton and South West Hampshire Local Research Ethics Committees, 6 November 2003 ref: 120/01/t |
| Health condition(s) or problem(s) studied | Tongue-tie |
| Intervention | 1. Both participants & the observer were blinded to the intervention 2. Tongue-tie division and non-division 3. Unblinded follow up at 1 day & 3 months |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Subjective and objective change in breastfeeding |
| Key secondary outcome measure(s) |
1. Subjective changes in breastfeeding |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 4 Months |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Less than 4 months of age 2. Tongue-tie present 3. Symptomatic of breastfeeding problem |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 30/10/2003 |
| Date of final enrolment | 31/07/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
