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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
120/01/t
Study information
Scientific title
A double-blind, randomised, controlled trial of tongue-tie division and its immediate effect on breastfeeding
Acronym
Study hypothesis
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
Southampton and South West Hampshire Local Research Ethics Committees, 6 November 2003 ref: 120/01/t
Study design
Single centre double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
1. Subjective and objective change in breastfeeding
2. Maternal pain score
Secondary outcome measures
1. Subjective changes in breastfeeding
2. Breastfeeding rates
3. Complications and acceptability of procedure to parents
Overall trial start date
30/10/2003
Overall trial end date
31/07/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Less than 4 months of age
2. Tongue-tie present
3. Symptomatic of breastfeeding problem
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
60
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
30/10/2003
Recruitment end date
31/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wessex Regional Centre for Paediatric Surgery
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Southampton University Hospitals NHS Trust (UK)
Sponsor details
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Southampton University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/21999476
Publication citations
-
Results
Berry J, Griffiths M, Westcott C, A double-blind, randomized, controlled trial of tongue-tie division and its immediate effect on breastfeeding., Breastfeed Med, 2012, 7, 3, 189-193, doi: 10.1089/bfm.2011.0030.