Frenulum BreveRE-GLUNCT04440462
Analgesia in Lingual Frenulotomy in the Newborn
A study testing Sugar and water solution and Sterile water in people with Frenulum Breve, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Ankyloglossia (tongue-tie) is a congenital anomaly characterized by a short lingual frenulum that limits the physiological tongue movement and occurs with an estimated prevalence between 4 and 10% of the newborns. Read more about this study
- Who is it for?
- Ages 1 day to 10 days
- Conditions the study is for
- Frenulum Breve
- What is being tested?
- Sugar and water solution and Sterile water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 18 Sep 2020to 31 Dec 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 1 day to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term newborns (37 - 41 weeks of gestational age) within the first 10 days of life;
- Birth weight ≥ 2500 grams;
- Presence of ankyloglossia;
- Indication to the frenulotomy according to the Hazelbaker Assessment Tool for Lingual Frenulum Function (HATLFF): anatomical-functional evaluation with a score lower than 8.
Who cannot join
- Syndromic diagnosis (genetic/hereditary);
- Pathology of main organ (heart disease, brain disease etc.);
- Drugs intake that may interfere with the collected data (sedatives).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Trieste, Trieste, 34137
About this study
Official title: Lingual Frenulotomy in the Newborn: a Randomized Clinical Trial to Evaluate the Analgesic Effect of a Water and Sugar Solution in a Minor Surgical Procedure
Ankyloglossia (tongue-tie) is a congenital anomaly characterized by a short lingual frenulum that limits the physiological tongue movement and occurs with an estimated prevalence between 4 and 10% of the newborns. This condition can be associated with difficulty in breastfeeding which can be painful for the mother, dysfunctional swallowing and future speech difficulties. The prevalence of nipple pain among women breastfeeding newborns with ankyloglossia is estimated to be between 36 and 80%. Since an early intervention can prevent the difficulties that may occur during the child's growth and can also improve the mothers and patients' quality of life, it is important to evaluate the lingual frenulum in the first days of life. The treatment of ankyloglossia consists in the frenulotomy which allows the release of the lingual frenulum and is a relatively simple procedure with few side effects and minimal post-operative. Different methods performed with or without local anaesthesia by means of scissors, blade, laser (etc.) are described in literature for the procedure the newborn.
The hypothesis of the study is that the addition of a water and sugar solution to the standard analgesia with lidocaine may lead to a greater benefit in terms of pain control and determine the activation of different brain areas.
Read more
The primary aim of the study is to evaluate whether the administration of a water and sugar solution to newborns undergoing frenulotomy receiving topical lidocaine as standard analgesic protocol, may lead to an additional benefit in terms of pain reduction evaluated according to the Neonatal Infant Pain Scale (NIPS).
The secondary aim of the study is to evaluate through a Hitachi multichannel near-infrared spectroscopy (NIRS) the effects of the addition of a water and sugar solution to the standard analgesic protocol with topical lidocaine on the cortical activation.
- Conditions
- Frenulum Breve
- Being tested
- Sugar and water solution, Sterile water
- Keywords
- Ankyloglossia, Frenulotomy, water and sugar solution
- Medical subject headings
- Ankyloglossia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar and water solutionOther
2 ml of a water and sugar solution (3 full-teaspoons of granulated sugar dissolved in half glass of water)
Sterile waterOther
2 ml of sterile water
| Study group | Role | What they receive |
|---|---|---|
| Sugar and water solution | Experimental | 2 ml of a water and sugar solution (3 full-teaspoons of granulated sugar dissolved in half glass of water) Receives: Other: Sugar and water solution |
| Sterile water | Active comparator | 2 ml of sterile water Receives: Other: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
The perception of pain in newborns will be evaluated according to the Internationally Validated Neonatal Infant Pain Scale (NIPS).This scale detects the presence of six behavioral expression signs of neonatal pain (facial expression, crying, respiratory pattern, arms and legs' activity, arousal state) and ranges from 0 (absence of pain) to 7 (maximal pain level).
Measured: 30 seconds after the frenulotomy
Secondary outcomes (2)
Pain reduction
The perception of pain in newborns will be evaluated according to the Internationally Validated Neonatal Infant Pain Scale (NIPS).This scale detects the presence of six behavioral expression signs of neonatal pain (facial expression, crying, respiratory pattern, arms and legs' activity, arousal state) and ranges from 0 (absence of pain) to 7 (maximal pain level).
Measured: During the frenulotomy
Cortical oxy-haemoglobin change
Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2) (Hitachi multichannel NIRS system)
Measured: 30 seconds after the frenulotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start18 Sep 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frenulum BreveStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maddalena Chermetz, DDS MSc, Principal investigator, Institute for maternal and child health Burlo GarofoloMilena Cadenaro, DDS MSc PhD, Study director, Institute for maternal and child health Burlo GarofoloChiara Navarra, DDS MSc PhD, Principal investigator, Institute for maternal and child health Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440462
- Sponsor's protocol ID
- RC 13/2019
- Acronym
- RE-GLU
- Status last verified
- May 2025
- First submitted
- 18 Jun 2020
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lingual Frenulotomy in the Newborn: a Randomized Clinical Trial to Evaluate the Analgesic Effect of a Water and Sugar Solution in a Minor Surgical Procedure
- ClinicalTrials.gov ID
- NCT04440462
- Acronym / sponsor ID
- RE-GLU / RC 13/2019
- Conditions
- Frenulum Breve
- Keywords
- Ankyloglossia, Frenulotomy, water and sugar solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Jun 2020 (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.
Ankyloglossia (tongue-tie) is a congenital anomaly characterized by a short lingual frenulum that limits the physiological tongue movement and occurs with an estimated prevalence between 4 and 10% of the newborns. This condition can be associated with difficulty in breastfeeding which can be painful for the mother, dysfunctional swallowing and future speech difficulties. The prevalence of nipple pain among women breastfeeding newborns with ankyloglossia is estimated to be between 36 and 80%. Since an early intervention can prevent the difficulties that may occur during the child's growth and can also improve the mothers and patients' quality of life, it is important to evaluate the lingual frenulum in the first days of life. The treatment of ankyloglossia consists in the frenulotomy which allows the release of the lingual frenulum and is a relatively simple procedure with few side effects and minimal post-operative. Different methods performed with or without local anaesthesia by means of scissors, blade, laser (etc.) are described in literature for the procedure the newborn.
The hypothesis of the study is that the addition of a water and sugar solution to the standard analgesia with lidocaine may lead to a greater benefit in terms of pain control and determine the activation of different brain areas.
The primary aim of the study is to evaluate whether the administration of a water and sugar solution to newborns undergoing frenulotomy receiving topical lidocaine as standard analgesic protocol, may lead to an additional benefit in terms of pain reduction evaluated according to the Neonatal Infant Pain Scale (NIPS).
The secondary aim of the study is to evaluate through a Hitachi multichannel near-infrared spectroscopy (NIRS) the effects of the addition of a water and sugar solution to the standard analgesic protocol with topical lidocaine on the cortical activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar and water solution | Experimental | Other: Sugar and water solution2 ml of a water and sugar solution (3 full-teaspoons of granulated sugar dissolved in half glass of water) |
| Sterile water | Active comparator | Other: Sterile water2 ml of sterile water |
Who may qualify
- Ages
- 1 day to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Term newborns (37 - 41 weeks of gestational age) within the first 10 days of life;
- Birth weight ≥ 2500 grams;
- Presence of ankyloglossia;
- Indication to the frenulotomy according to the Hazelbaker Assessment Tool for Lingual Frenulum Function (HATLFF): anatomical-functional evaluation with a score lower than 8.
Key exclusion criteria (3 listed)
- Syndromic diagnosis (genetic/hereditary);
- Pathology of main organ (heart disease, brain disease etc.);
- Drugs intake that may interfere with the collected data (sedatives).
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 |
|---|---|---|
| Sugar and water solution2 ml of a water and sugar solution (3 full-teaspoons of granulated sugar dissolved in half glass of water) | Other | Sugar and water solution |
| Sterile water2 ml of sterile water | Other | Sterile water |
Primary outcome
Pain reduction
Time frame: 30 seconds after the frenulotomy
The perception of pain in newborns will be evaluated according to the Internationally Validated Neonatal Infant Pain Scale (NIPS).This scale detects the presence of six behavioral expression signs of neonatal pain (facial expression, crying, respiratory pattern, arms and legs' activity, arousal state) and ranges from 0 (absence of pain) to 7 (maximal pain level).
2 secondary outcomes
Pain reduction
Time frame: During the frenulotomy
Cortical oxy-haemoglobin change
Time frame: 30 seconds after the frenulotomy
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 7 May 2025.
- Individual participant dataSharing planned: No
Related trials for Frenulum Breve
Active, not recruiting
Lingual Frenulum in Newborn Infants (LINNE)
Tongue Tie, Frenulum Breve
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.
Maddalena Chermetz, DDS MSc principal investigator
Institute for maternal and child health Burlo Garofolo
Milena Cadenaro, DDS MSc PhD study director
Institute for maternal and child health Burlo Garofolo
Chiara Navarra, DDS MSc PhD principal investigator
Institute for maternal and child health Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar and water solution and Sterile water in people with Frenulum Breve, run by IRCCS Burlo Garofolo at 1 site in Italy.
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 4 inclusion and 3 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 7 May 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 Italy. 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?
Pain reduction (time frame: 30 seconds after the frenulotomy). 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 7 May 2025.