Breastfeeding and reflux improvement, the effect of frenulotomy
| ISRCTN | ISRCTN64428423 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64428423 |
| Secondary identifying numbers | METc 2014/375 |
- Submission date
- 30/08/2017
- Registration date
- 21/09/2017
- Last edited
- 26/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
University Medical Centre Groningen
Hanzeplein 1
Groningen
9700RB
Netherlands
| Phone | +31 503 128203 |
|---|---|
| info@boefjesstudie.nl |
Study information
| Study design | Single centre prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Participant information sheet can be found at the following website: www.boefjesstudie.nl |
| Scientific title | Breastfeeding improvement after frenectomy tongue- and lip tie |
| Study 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(s) | Medical Ethical Board of the University Medical Centre Groningen, 11/09/2014, ref: METc 2014/375 |
| 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 |
| 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 study start date | 01/09/2017 |
| Overall study end date | 01/12/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 152 |
| Total final enrolment | 175 |
| Participant inclusion criteria | 1. Newborns under 6 months 2. Are breast fed 3. Untreated ankyloglossia and/or tethered maxillary labial frenula |
| 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
Study participating centre
Groningen
9700 RB
Netherlands
Sponsor information
Hospital/treatment centre
Hanzeplein 1
Groningen
9700RB
Netherlands
| Website | www.umcg.nl |
|---|---|
"ROR" |
https://ror.org/03cv38k47 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2020 | 26/01/2021 | Yes | No |
Editorial Notes
26/01/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
