Condition category
Not Applicable
Date applied
22/06/2011
Date assigned
15/07/2011
Last edited
24/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mr Mervyn Griffiths

ORCID ID

Contact details

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

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 measures

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

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

http://www.suht.nhs.uk/home.aspx

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/21999476

Publication citations

  1. 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.

Additional files

Editorial Notes