Infant Nutrition DisordersNCT05946590
Breastfeeding Duration and Tongue-tie in Neonates.
A study testing Frenotomy in people with Infant Nutrition Disorders, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The goal of this observational study is to examine how performed frenotomy in term-born infants influences the breastfeeding duration. The main questions the study aims to answer are how a suspected tongue-tie, vacuum strength, and breastfeeding may be associated. Read more about this study
- Who is it for?
- Ages Up to 49 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition Disorders
- What is being tested?
- Frenotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Nov 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 49 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant of an adult mother Delivery after 37 completed gestational weeks. Singleton or twin Infant of a mother who intends to breastfeed. At least one parents speak and write English, Danish, Norwegian, or Swedish.
Who cannot join
- Congenital malformation. Reduced lung function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Duration of Exclusive Breastfeeding and Tongue-tie in Neonates.
The goal of this observational study is to examine how performed frenotomy in term-born infants influences the breastfeeding duration. The main questions the study aims to answer are how a suspected tongue-tie, vacuum strength, and breastfeeding may be associated. Families of infants with tongue-tie where frenotomy is suspected will be invited to participate. Intra-oral vacuum measurements before and 5-10 days after frenotomy will be obtained and the breastfeeding status followed for 6 months.
Read the detailed description
Exclusive breastfeeding is defined as feeding the infant with human breast milk only, except for vitamins, minerals supplements and medicine. It is an official recommendation that infants are exclusively breastfed for 6 months. Approximately 60% and 15% of Danish infants are exclusively breastfed for 4 and 6 months respectively. There are many factors that may interfere with the establishment and duration of breastfeeding.
For the infant, breastfeeding depends on the infant´s ability to seal the oral cavity around the breast and integrate the muscular activities of cheeks, lips, jaw, and tongue. Effectively nutritive sucking occurs due to the application of positive pressure when the tongue moves upwards to express milk, followed by an intra-oral vacuum (vacuum) when the tongue moves downwards and draws milk from the breast by suction. The strength of vacuum affects the effectiveness of milk removal from the breast and regulates the volume of milk. A weak vacuum may, therefore, lead to a shortage of milk transfer, diminished milk supply and early breastfeeding stop. Conversely, was in a recently published study found an association between a high vacuum and infants who were exclusively breastfed for the recommended 6 months.
Difficulties in creating an appropriate vacuum may be related to ankyloglossia, tight frenulum also called tongue-tie, a condition in which the lingual frenulum has anterior attachment near the tip of the tongue and/or are unusually thick, tight, and/or short lingual frenulum. Tongue-tie is often detected when the infant shows signs of difficulties during breastfeeding and/or there is maternal nipple pain. The possible consequence of tongue-tie is insufficient infant weight gain, neonatal dehydration, and shortened breastfeeding duration.
In case of breastfeeding difficulties, it is recommended to evaluate the tongue-tie by the Breastfed Babies Assessment Tool score (TABBY) and depending on this assessment frenotomy may be recommended. The value of both the TABBY score and frenotomy is only poorly validated.
Hypothesis We hypothesise vacuum to increase after frenotomy and, thereby, affect breastfeeding duration positively.
- Conditions
- Infant Nutrition Disorders
- Being tested
- Frenotomy
- Keywords
- Ankyloglossia, Frenotomy, Infants, Intra-oral vacuum, Breastfeeding
- Medical subject headings
- Infant Nutrition Disorders, Ankyloglossia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FrenotomyProcedure or surgery
Also called Frenulum release
Frenotomy in which clipping/incised of the lingual frenulum releases the tongue-tie performed by a health care professional
| Study group | Role | What they receive |
|---|---|---|
| Frenotomy | Other | Frenotomy performed by a health care professional Receives: Procedure: Frenotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding duration
The duration of exclusive and partial breastfeeding
Measured: Followed 6 months.
Secondary outcomes (2)
TABBY score
The association between tongue-tie, TABBY score, and vacuum strength.
Measured: Before and 5-10 days after performed frenotomy.
Delta intra-oral vacuum
The primary outcome is to investigate any difference in vacuum in infants below 42 days
Measured: Before, within 1 hour after and 5-10 days after performed frenotomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start17 Nov 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An exploratory prospective cohort study.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Skaaning, Hvidovre University Hospital
- Investigators
- Diana Skaaning, Principal investigator, Region Hovedstadens Apotek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946590
- Sponsor's protocol ID
- VEC 99694
- Status last verified
- Apr 2024
- First submitted
- 29 Jun 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All personal information about potential and enrolled participants will be collected, shared, and maintained under protected confidentiality before, during, and after the study period according to Capital Region at Knowledge Center for Data Reviews and the General Data Protection Regulation.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Duration of Exclusive Breastfeeding and Tongue-tie in Neonates.
- ClinicalTrials.gov ID
- NCT05946590
- Acronym / sponsor ID
- VEC 99694
- Conditions
- Infant Nutrition Disorders
- Keywords
- Ankyloglossia, Frenotomy, Infants, Intra-oral vacuum, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to examine how performed frenotomy in term-born infants influences the breastfeeding duration. The main questions the study aims to answer are how a suspected tongue-tie, vacuum strength, and breastfeeding may be associated. Families of infants with tongue-tie where frenotomy is suspected will be invited to participate. Intra-oral vacuum measurements before and 5-10 days after frenotomy will be obtained and the breastfeeding status followed for 6 months.
Detailed description
Exclusive breastfeeding is defined as feeding the infant with human breast milk only, except for vitamins, minerals supplements and medicine. It is an official recommendation that infants are exclusively breastfed for 6 months. Approximately 60% and 15% of Danish infants are exclusively breastfed for 4 and 6 months respectively. There are many factors that may interfere with the establishment and duration of breastfeeding.
For the infant, breastfeeding depends on the infant´s ability to seal the oral cavity around the breast and integrate the muscular activities of cheeks, lips, jaw, and tongue. Effectively nutritive sucking occurs due to the application of positive pressure when the tongue moves upwards to express milk, followed by an intra-oral vacuum (vacuum) when the tongue moves downwards and draws milk from the breast by suction. The strength of vacuum affects the effectiveness of milk removal from the breast and regulates the volume of milk. A weak vacuum may, therefore, lead to a shortage of milk transfer, diminished milk supply and early breastfeeding stop. Conversely, was in a recently published study found an association between a high vacuum and infants who were exclusively breastfed for the recommended 6 months.
Difficulties in creating an appropriate vacuum may be related to ankyloglossia, tight frenulum also called tongue-tie, a condition in which the lingual frenulum has anterior attachment near the tip of the tongue and/or are unusually thick, tight, and/or short lingual frenulum. Tongue-tie is often detected when the infant shows signs of difficulties during breastfeeding and/or there is maternal nipple pain. The possible consequence of tongue-tie is insufficient infant weight gain, neonatal dehydration, and shortened breastfeeding duration.
In case of breastfeeding difficulties, it is recommended to evaluate the tongue-tie by the Breastfed Babies Assessment Tool score (TABBY) and depending on this assessment frenotomy may be recommended. The value of both the TABBY score and frenotomy is only poorly validated.
Hypothesis We hypothesise vacuum to increase after frenotomy and, thereby, affect breastfeeding duration positively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An exploratory prospective cohort study.
| Arm | Type | Receives |
|---|---|---|
| Frenotomy | Other | Procedure: FrenotomyFrenotomy performed by a health care professional |
Who may qualify
- Ages
- Up to 49 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infant of an adult mother Delivery after 37 completed gestational weeks. Singleton or twin Infant of a mother who intends to breastfeed. At least one parents speak and write English, Danish, Norwegian, or Swedish.
Key exclusion criteria (1 listed)
- Congenital malformation. Reduced lung function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FrenotomyAlso: Frenulum releaseFrenotomy in which clipping/incised of the lingual frenulum releases the tongue-tie performed by a health care professional | Procedure or surgery | Frenotomy |
Primary outcome
Breastfeeding duration
Time frame: Followed 6 months.
The duration of exclusive and partial breastfeeding
2 secondary outcomes
TABBY score
Time frame: Before and 5-10 days after performed frenotomy.
Delta intra-oral vacuum
Time frame: Before, within 1 hour after and 5-10 days after performed frenotomy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No. All personal information about potential and enrolled participants will be collected, shared, and maintained under protected confidentiality before, during, and after the study period according to Capital Region at Knowledge Center for Data Reviews and the General Data Protection Regulation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Skaaning principal investigator
Region Hovedstadens Apotek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frenotomy in people with Infant Nutrition Disorders, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding duration (time frame: Followed 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.