ISRCTN - ISRCTN73554751: Tongue tie and frenotomy: a feasibility randomised controlled trial

Plain English Summary

Background and study aims
Babies are sometimes born with a tongue tie. This is where the flesh which holds the tongue to the floor of the mouth, underneath the tongue, is too tight or too long and hence the baby cannot move the tongue as much as a normal baby. It is said that up to 3% of babies are affected i.e. a lot of babies.
It is possible to snip the tongue tied tissue (called the frenulum) and release the tongue tie. Recently this has become a spreading practice across different places in the UK. The reason this is done is that by releasing the tongue, the affected baby can breast feed more easily as able to latch onto the mothers breast without causing pain to the mother or irritation and failure of breast feeding.
We are conducting a study which will attempt to determine a way of measuring tongue tied babies, assessing their breast feeding, and if deemed to be tongue tied just after birth, the Mum will be invited to join our study. It is uncertain if cutting the tongue tie (called frenotomy) really does result in better breast feeding and also sustained breast feeding. Previous research has not been conclusive and that is why an initial study is required.

Who can participate?
100 babies and their Mums in the first few weeks after birth. If a baby is assessed to have severe tongue tie, they will not be invited to participate. We will not involve premature or other babies needing ongoing in patient medical care. Only mature term babies will be invited (via their Mums!) to be involved.

What does the study involve?
If the Mums agree to participate they will be randomly allocated to either immediate tongue tie treatment or a delay of 5 days whereby standard breast feeding advice /support will be given. If the infant is still struggling to feed, tongue tie release will be done on the other half of the group (i.e. 50 babies) at day 5 after study entry. Some babies at that point could be feeding well without that help.
Assessments will look at breast feeding competency including a questionnaire filled in by the Mums after the tongue tie treatment.

What are the possible benefits and risks of participating?
Frenotomy is a simple procedure done by a trained midwife and causes minimal discomfort to the baby.
If we find that we can involve 100 Mums and their babies over this time frame and our measures of assessment prove reliable and useful, a larger study will be run. If we show that tongue tie treatment genuinely benefits breast feeding babies, it would make a case for every district to offer this service.

Where is the study run from?
The study is carried out in Southmead Hospital Bristol, UK.

When is study starting and how long is it expected to run for?
October 2011 to October 2012.

Who is funding the study?
National Institure for Health Research (NIHR), UK

Who is the main contact?
Dr Sutcliffe
a.sutcliffe@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alastair Sutcliffe

ORCID ID

Contact details

Institute of Child Health
General and Adolescent Paediatrics Unit
University College London
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7794 0500 x 35169
a.sutcliffe@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10588

Study information

Scientific title

A feasibility study for a randomised controlled trial to measure the impact of frenotomy in breastfed infants with tongue tie

Acronym

Study hypothesis

A pilot study involving infants in their first few weeks of life whose mothers experience difficulty in breast feeding thought to be due to Tongue Tie.

Ethics approval

ref: 11/SW/0087

Study design

Interventional, treatment, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics

Intervention

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 Hazelbaker tool for tongue tie severity and reassessed at day 5.
Those randomised to delayed frenotomy will be given standard breast feeding support.
The main aim of the feasibility study is to establish if Mothers are willing to participate and complete the protcol. this will be a single blind assessment in which a person unaware of frentomy status will do the LATCH and other assessments.
Follow Up Length: 2 month(s); Study Entry: Single Randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

LATCH score, measured pre and post frenotomy

Secondary outcome measures

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

Overall trial start date

03/10/2011

Overall trial end date

02/10/2012

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100; Description: This is a feasibility study which would determine sample size for a main study.

Participant 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

Recruitment start date

03/10/2011

Recruitment end date

02/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Child Health
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Southmead Hospital (UK)

Sponsor details

Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.nbt.nhs.uk/find_us/southmead_hospital.aspx

Funders

Funder type

Government

Funder name

National Institure for Health Research (NIHR) - Research for Patient Benefit (RfPB)

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