AnkyloglossiaNCT05135481
Dedicated Lactation Support in Infants With Tongue - Tie; a Randomised Control Trial
A study testing phrenectomy and Increased lactation support in people with Ankyloglossia and Breast Feeding, Exclusive, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 1 site in Poland.
Trial summary
The investigators are registering a randomised controlled trial to assess whether dedicated, intensified lactation support is as good as frenotomy on the incidence of breastfeeding among term infants with ankyloglossia. Read more about this study
- Who is it for?
- Ages 1 minute to 48 hours
- Conditions the study is for
- Ankyloglossia, Breast Feeding, Exclusive, Lactation Failure
- What is being tested?
- phrenectomy and Increased lactation support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePoland
- Study dates
- 8 Mar 2022to 31 Mar 2023
- 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 1 minute to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- full - term infants born with an Apgar score of 8-10 points
- no visual causes of lactation difficulties (malocclusion, posterior and small jaw, cervical torticollis, significant positional asymmetry)
- parental consent
Who cannot join
- hypotrophy
- low birth weight
- perinatal complications
- congenital craniofacial defects
- neurological diseases
- visible genetic syndromes
Show all 9Show fewer
- mother' unwilling to breastfeed
- no consent for vaccination against hepatitis B
- neonates born to HIV seropositive mothers
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, 00-315
About this study
Official title: Effect of Intensive Lactation Support vs Frenotomy on the Incidence of Breastfeeding in Term Infants: a Randomised Control Trial
The investigators are registering a randomised controlled trial to assess whether dedicated, intensified lactation support is as good as frenotomy on the incidence of breastfeeding among term infants with ankyloglossia.
Read the detailed description
The investigators plan to include a total 316 infants. The study will be carried out in level III hospital in Warsaw, Poland. The primary outcome will be exclusive breastfeeding at 12 weeks of age. Secondary outcomes include breastfeeding > 50% of feedings, improved breastfeeding comfort as assessed by the mother, weight gain, head circumference and length gain, the need to use a breast pump or lactation accessories, time of breastfeeding cessation, the type of lactation, neurological and rehabilitation assistance received, the frequency of obtained lactation, neurological and rehabilitation assistance.
- Being tested
- phrenectomy, Increased lactation support
- Medical subject headings
- Ankyloglossia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phrenectomyProcedure or surgery
The qualification for phrenectomy in group 1 will be made based on the Amir scale, i.e. a score of 4 and fewer points for the language function (2).
Increased lactation supportOther
Also called dedicated lactation support
Management in group 2 will include increased lactation care both during hospital stay and post discharge.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | Active comparator | The qualification for phrenectomy in group 1 will be made based on the Amir scale, i.e. a score of 4 and fewer points for the language function. Receives: Procedure: phrenectomy |
| STUDY GROUP | Experimental | Management in group 2 will include increased lactation care both during hospital stay and post discharge.
Increased lactation care will consist of:
individual consultations on how to properly attach the baby to the breast (at least 3 meetings during hospitalization with personnel trained in lactation counselling), regular (at least once a week) contact with a breastfeeding consultant as part of a closed group on social media or by phone, if necessary (expressed by the mother or based on a referral by a member of the lactation team) an outpatient appointment at the breastfeeding clinic. Receives: Other: Increased lactation support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of exclusively breastfeeding mothers
Proportion of exclusively breastfeeding mothers
Measured: at 12 weeks of age
Secondary outcomes (8)
Proportion of mother-baby dyads with a breastfeeding frequency of > 50%.
Proportion of mother-baby dyads with a breastfeeding frequency of > 50% of feedings, which will be assessed using the Breastfeeding Self-Efficacy Scale Short Form [9, 10]
Measured: at 12 weeks of age
Weight change
Median weight change
Measured: at 12 weeks of age
Head circumference change
Median head circumference change
Measured: at 12 weeks of age
Length change
Median length change
Measured: at 12 weeks of age
Incidence of using a breast pump or lactation accessories
Proportion of mothers needing to use a breast pump or lactation accessories (e.g. nipple shields)
Measured: at 12 weeks of age
Time of breastfeeding cessation
median time of breastfeeding cessation
Measured: during 12 weeks of age
Rate of additional consultations
Rate of consultations (e.g. speech therapist, rehabilitants, other lactation consultants) received by a mother - baby dyads.
Measured: during 12 weeks of age
Change in breastfeeding comfort
Proportion of mothers reporting change in breastfeeding comfort
Measured: at 12 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start8 Mar 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Why it stopped: recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnkyloglossiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Warsaw
- Responsible party
- Sponsor
- Investigators
- Joanna Seliga - Siwecka, MD PhD, Study director, Medical University of WarsawJustyna Fiałkowska, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135481
- Sponsor's protocol ID
- FRENO
- Status last verified
- Jul 2022
- First submitted
- 1 Nov 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive Lactation Support vs Frenotomy on the Incidence of Breastfeeding in Term Infants: a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05135481
- Acronym / sponsor ID
- FRENO
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: recruitment problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Medical University of Warsaw
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 26 Nov 2021 (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 investigators are registering a randomised controlled trial to assess whether dedicated, intensified lactation support is as good as frenotomy on the incidence of breastfeeding among term infants with ankyloglossia.
Detailed description
The investigators plan to include a total 316 infants. The study will be carried out in level III hospital in Warsaw, Poland. The primary outcome will be exclusive breastfeeding at 12 weeks of age. Secondary outcomes include breastfeeding > 50% of feedings, improved breastfeeding comfort as assessed by the mother, weight gain, head circumference and length gain, the need to use a breast pump or lactation accessories, time of breastfeeding cessation, the type of lactation, neurological and rehabilitation assistance received, the frequency of obtained lactation, neurological and rehabilitation assistance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | Active comparator | Procedure: phrenectomyThe qualification for phrenectomy in group 1 will be made based on the Amir scale, i.e. a score of 4 and fewer points for the language function. |
| STUDY GROUP | Experimental | Other: Increased lactation supportManagement in group 2 will include increased lactation care both during hospital stay and post discharge. Increased lactation care will consist of: individual consultations on how to properly attach the baby to the breast (at least 3 meetings during hospitalization with personnel trained in lactation counselling), regular (at least once a week) contact with a breastfeeding consultant as part of a closed group on social media or by phone, if necessary (expressed by the mother or based on a referral by a member of the lactation team) an outpatient appointment at the breastfeeding clinic. |
Who may qualify
- Ages
- 1 minute to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- full - term infants born with an Apgar score of 8-10 points
- no visual causes of lactation difficulties (malocclusion, posterior and small jaw, cervical torticollis, significant positional asymmetry)
- parental consent
Key exclusion criteria (9 listed)
- hypotrophy
- low birth weight
- perinatal complications
- congenital craniofacial defects
- neurological diseases
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 |
|---|---|---|
| phrenectomyThe qualification for phrenectomy in group 1 will be made based on the Amir scale, i.e. a score of 4 and fewer points for the language function (2). | Procedure or surgery | CONTROL GROUP |
| Increased lactation supportAlso: dedicated lactation supportManagement in group 2 will include increased lactation care both during hospital stay and post discharge. | Other | STUDY GROUP |
Primary outcome
Proportion of exclusively breastfeeding mothers
Time frame: at 12 weeks of age
Proportion of exclusively breastfeeding mothers
8 secondary outcomes
Proportion of mother-baby dyads with a breastfeeding frequency of > 50%.
Time frame: at 12 weeks of age
Weight change
Time frame: at 12 weeks of age
Head circumference change
Time frame: at 12 weeks of age
Length change
Time frame: at 12 weeks of age
Incidence of using a breast pump or lactation accessories
Time frame: at 12 weeks of age
Time of breastfeeding cessation
Time frame: during 12 weeks of age
Rate of additional consultations
Time frame: during 12 weeks of age
Change in breastfeeding comfort
Time frame: at 12 weeks of age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Joanna Seliga - Siwecka, MD PhD study director
Medical University of Warsaw
Justyna Fiałkowska, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phrenectomy and Increased lactation support in people with Ankyloglossia and Breast Feeding, Exclusive, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 1 site in Poland.
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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 21 Jul 2022. 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 Poland. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of exclusively breastfeeding mothers (time frame: at 12 weeks of age). 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 21 Jul 2022.