Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/08/2017
Date assigned
21/09/2017
Last edited
21/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The World Health Organization recommends breastfeeding babies for at least for six months. Unfortunately, due to breast-feeding problems, this is often not possible. There are many different causes of breast- feeding problems and include poor weight gain necessitating supplementation, poor latch, maternal nipple pain, and structural restrictions like a tongue tie (ankyloglossia) and/or lip tie. This is when the tongue has limited movement due to strip of skin that connects the baby’s tongue to the mouth is shorter than usual. Previous studies showed that a tongue tie (ankyloglossia) and/or a lip tie (tethered superior labial frenum) can cause altered latch and sucking mechanics. The suckling process is complex and multi- factorial, and dysfunction may cause diverse signs and symptoms in the breastfed baby. A frenectomy is a procedure that removed the piece of skin to allow more movement in the tongue. The aim of this study is to examine the effect on breastfeeding improvement and reflux problems after a frenectomy of ankyloglossia and/or tethered maxillary labial frenula.

Who can participate?
Newborns under six months with untreated ankyloglossia and/or tethered maxillary labial frenula with breastfeeding (and reflux) problems.

What does the study involve?
Participants are asked to fill in questionnaires to examine breastfeeding improvement,
reflux improvement and to describe pain during breastfeeding. Prior to the surgery a small amount of topical anesthetic cream (a numbing cream) is placed on the tongue and/or lip tie. Participants then receive the frenulotomy with diathermy done to the standard procedure. Participants are followed up was after one week, one month and six months with the same questionnaires.

What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating in the study, as the procedure is part of the standard procedure treating a tongue or lip tie.

Where is the study run from?
University Medical Centre Groningen (Switzerland)

When is the study starting and how long is it expected to run for?
September 2017 to December 2018

Who is funding the study?
University Medical Centre Groningen (Switzerland)

Who is the main contact?
Dr Kirsten Slagter
info@boefjesstudie.nl

Trial website

www.boefjesstudie.nl

Contact information

Type

Scientific

Primary contact

Dr Kirsten Slagter

ORCID ID

Contact details

University Medical Centre Groningen
Hanzeplein 1
Groningen
9700RB
Netherlands
+31 503 128203
info@boefjesstudie.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

METc 2014/375

Study information

Scientific title

Breastfeeding improvement after frenectomy tongue- and lip tie

Acronym

BOEFjes study

Study hypothesis

The aim of this study is to examine the effect on breastfeeding improvement and reflux problems after a frenectomy of ankyloglossia and/or tethered maxillary labial frenula.

Ethics approval

Medical Ethical Board of the University Medical Centre Groningen, 11/09/2014, ref: METc 2014/375

Study design

Single centre prospective observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Participant information sheet can be found at the following website: www.boefjesstudie.nl

Condition

Newborns with untreated ankyloglossia and/or tethered maxillary labial frenula with breastfeeding (and reflux) problems.

Intervention

Study enrollment and informed consent were completed subsequent to standard surgical consent. Participants were orally examined if restrictions were present and standardized classification systems were used to describe frenula anatomy. Breastfeeding mothers were asked to fill in questionnaires to examine Breastfeeding improvement ( BSES-SF (Breastfeeding Self-Efficacy Scale Short Form questionnaire)), Reflux improvement (I-GERQ-R (Infant-Gastroesophagal Reflux Questionnaire- Revised)) and to describe pain during breastfeeding with the Visual Analogue Scale (VAS). Prior to the surgery a small amount of topical anesthetic cream was placed on the tongue and/or lip tie.

Participants receive a surgical procedure called a frenulotomy of a tied tong tie and/ or lip tie. Frenectomy of the untreated ankyloglossia and/or tethered maxillary labial frenula. The frenulotomy is performed by using diathermy. The duration of the surgery is 10 seconds with the use of surface anesthesia, and the follow-up for all patients is after one week, one month and 6 months. Participants are followed up to see if breastfeeding has improved using the same questionnaires.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Breastfeeding improvement is measured using the BSES-SF (Breastfeeding Self-Efficacy Scale Short Form) questionnaire at one week, one month and six months.

Secondary outcome measures

1. Reflux improvement is emasured using the I-GERQ-R (Infant-Gastroesophagal Reflux Questionnaire- Revised) at one week, one month and six months
2. Pain during breastfeeding is measured using the Visual Analogue Scale (VAS) at one week, one month and six months.

Overall trial start date

01/09/2017

Overall trial end date

01/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Newborns under 6 months
2. Are breast fed
3. Untreated ankyloglossia and/or tethered maxillary labial frenula

Participant type

Healthy volunteer

Age group

Neonate

Gender

Both

Target number of participants

152

Participant exclusion criteria

1. Older then 6 months
2. Premature born
3. Unhealthy
4. Formula fed
5. Already revised ankyloglossia and/or tethered maxillary labial frenula

Recruitment start date

01/10/2017

Recruitment end date

01/06/2018

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Groningen
Hanzeplein 1
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen

Sponsor details

Hanzeplein 1
Groningen
9700RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

www.umcg.nl

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Groningen

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal one year after the trials. A short summary of the protocol in Dutch is online at www.boefjesstudie.nl

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from dr.K.W.Slagter, DDS,PhD at info@boefjesstudie.nl

Intention to publish date

01/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes