A trial of tongue-tie division and its immediate effect on breastfeeding

ISRCTN ISRCTN24575064
DOI https://doi.org/10.1186/ISRCTN24575064
Secondary identifying numbers 120/01/t
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

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

Mr Mervyn Griffiths
Scientific

Wessex Regional Centre for Paediatric Surgery
Southampton General Hopital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Study information

Study designSingle centre double-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA double-blind, randomised, controlled trial of tongue-tie division and its immediate effect on breastfeeding
Study hypothesisThat 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
ConditionTongue-tie
Intervention1. 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 typeOther
Primary outcome measure1. Subjective and objective change in breastfeeding
2. Maternal pain score
Secondary outcome measures1. Subjective changes in breastfeeding
2. Breastfeeding rates
3. Complications and acceptability of procedure to parents
Overall study start date30/10/2003
Overall study end date31/07/2004

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit4 Months
SexBoth
Target number of participants60
Participant inclusion criteria1. Less than 4 months of age
2. Tongue-tie present
3. Symptomatic of breastfeeding problem
Participant exclusion criteriaDoes not meet inclusion criteria
Recruitment start date30/10/2003
Recruitment end date31/07/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Wessex Regional Centre for Paediatric Surgery
Southampton
SO16 6YD
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Website http://www.suht.nhs.uk/home.aspx
ROR logo "ROR" https://ror.org/0485axj58

Funders

Funder type

Hospital/treatment centre

Southampton University Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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