Infant, PrematurePhase 4NEORINNCT07650552
Fentanyl and Rocuronium for Tracheal Intubation in Newborns
A Phase 4 study testing Rocuronium Bromide 10 MG/ML and Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation. in people with Infant, Premature and Intubation, Intratracheal, run by UEA - Universidade Do Estado Do Amazonas at 1 site in Brazil.
Trial summary
Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen desaturation, bradycardia, and airway trauma - are frequent. Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Infant, Premature, Intubation, Intratracheal, Respiratory Distress Syndrome, Newborn
- What is being tested?
- Rocuronium Bromide 10 MG/ML and Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2026to Feb 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns admitted to the NICU, ≤28 postnatal days OR corrected gestational age <44 weeks
- Indication for non-emergent orotracheal intubation (≥5 minutes between decision to intubate and start of laryngoscopy)
- Informed consent signed by legal guardians
Who cannot join
- Upper airway malformations
- Use of neuromuscular blocking agent in the 24 hours prior to enrollment
- Known hypersensitivity to fentanyl or rocuronium
- Severe hemodynamic instability (ongoing shock)
- Anticipated difficult airway (micrognathia, cleft palate, or similar)
- Cyanotic congenital heart disease with critical instability
- Neonatal abstinence syndrome
- Concurrent enrollment in another interventional clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Maternidade Ana Braga - UTI Neonatal
Manaus, Amazonas, 69057000
JEFFERSON PEREIRA GUILHERME, M.D.; PhD candidate, +55 92 981228890, jpguilherme@uea.edu.br
About this study
Official title: Effect of the Association of Fentanyl and Rocuronium on First-Attempt Success Rate of Tracheal Intubation in Newborns: A Randomized Clinical Trial
Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen desaturation, bradycardia, and airway trauma - are frequent. Premedication with neuromuscular blocking agents has been associated with improved intubation conditions and fewer adverse events in neonates.
This randomized, double-blind, parallel-group clinical trial (NEORIN) aims to evaluate whether the addition of rocuronium (0,6 mg/kg IV) to standard fentanyl premedication (1 mcg/kg IV) improves first-attempt success rates of tracheal intubation in newborns admitted to the NICU of Maternidade Ana Braga, Manaus, Brazil. The control group will receive fentanyl plus saline placebo. Sugammadex (16 mg/kg IV) is available as a reversal agent in case of prolonged neuromuscular blockade.
A secondary aim is to assess neonatologists' and residents' knowledge of and barriers to the use of neuromuscular blocking agents in neonatal intubation.
Read the detailed description
Neonatal tracheal intubation is performed in approximately 15-20% of NICU admissions. First-attempt success rates are approximately 49%, and adverse tracheal intubation-associated events (TIAEs) occur in up to 18% of procedures, with severe oxygen desaturation in up to 48% (NEAR4NEOS registry, Foglia et al., 2019). Premedication with neuromuscular blocking agents has been independently associated with a 62% reduction in adverse events (aOR 0.38; 95% CI 0.25-0.57).
Rocuronium is a non-depolarizing neuromuscular blocking agent with rapid onset, stable hemodynamic profile, and full reversibility with sugammadex, making it a safe choice for neonatal premedication.
The NEORIN trial will enroll 102 newborns (51 per group) with postnatal age ≤28 days or corrected gestational age <44 weeks, requiring non-emergent tracheal intubation. Randomization will be performed in variable-sized permuted blocks (4 and 6), with allocation concealment through sequential opaque sealed envelopes.
Intervention group: fentanyl 1 mcg/kg IV + rocuronium 0.6 mg/kg IV. Control group: fentanyl 1 mcg/kg IV + saline placebo (equivalent volume). Sugammadex is available at the bedside throughout the study as a mandatory safety requirement.
The primary composite outcome is first-attempt intubation success without physiological instability, defined as correct tube placement on the first laryngoscopy attempt confirmed by colorimetric CO2 detection, with no SpO2 drop >20% from baseline and no bradycardia (HR <100 bpm). All procedures will be video-recorded for blinded outcome assessment.
A secondary descriptive study will assess neonatologists' and residents' knowledge of and barriers to neuromuscular blocking agent use in neonatal intubation, using a structured questionnaire applied before the start of the clinical trial.
- Conditions
- Infant, Premature, Intubation, Intratracheal, Respiratory Distress Syndrome, Newborn, Apnea of Prematurity
- Being tested
- Rocuronium Bromide 10 MG/ML, Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation.
- Keywords
- neonatal intubation, rocuronium, premedication, neuromuscular blocking agent, sugammadex, first-attempt success, NICU, newborn
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome, Newborn, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium Bromide 10 MG/MLDrug
Rocuronium 0.6 mg/kg IV, single dose, administered as a bolus after fentanyl 1 mcg/kg IV, approximately 60 seconds before laryngoscopy
Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation.Drug
Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl + Rocuronium | Experimental | Fentanyl 1 mcg/kg IV followed by rocuronium 0.6 mg/kg IV, administered sequentially before non-emergent tracheal intubation. Receives: Drug: Rocuronium Bromide 10 MG/ML |
| Fentanyl Only | Active comparator | Fentanyl 1 mcg/kg IV administered before non-emergent tracheal intubation, without neuromuscular blocking agent. Receives: Drug: Rocuronium Bromide 10 MG/ML; Drug: Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-attempt intubation success without physiological instability
Composite outcome defined as correct endotracheal tube placement on the first laryngoscopy attempt, confirmed by colorimetric CO2 detection, with no SpO2 drop greater than 20% from baseline and no bradycardia (heart rate below 100 bpm) of any duration. A new attempt is defined as removal and reinsertion of the laryngoscope blade into the oral cavity.
Measured: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Secondary outcomes (7)
Total number of intubation attempts
Total number of laryngoscopy attempts required to achieve successful tracheal intubation, defined as each insertion of the laryngoscope blade into the oral cavity until its removal, regardless of tube insertion.
Measured: During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes)
Procedure duration
Time in seconds from the first laryngoscopy attempt to confirmation of correct endotracheal tube position by colorimetric CO2 detection.
Measured: From first laryngoscopy attempt to confirmation of endotracheal tube position, assessed during the intubation procedure (up to 5 minutes)
Severe oxygen desaturation
Occurrence of SpO2 drop greater than 20% from baseline value or SpO2 below 80%, at any point during the intubation procedure.
Measured: During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes)
Bradycardia during intubation
Occurrence of heart rate below 100 bpm at any point during the intubation procedure.
Measured: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Need for additional maneuvers
Need for any additional maneuver during intubation, including external laryngeal manipulation, blade change, stylet use, or change of intubating physician.
Measured: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Medication-related adverse events
Occurrence of adverse events related to study medications, including hypotension, chest wall rigidity, allergic reactions, or need for sugammadex due to prolonged neuromuscular blockade.
Measured: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Knowledge and barriers to neuromuscular blocking agent use
Score on a structured questionnaire assessing neonatologists' and residents' knowledge, attitudes, and barriers to the use of neuromuscular blocking agents in neonatal tracheal intubation. Applied as a descriptive cross-sectional sub-study before the start of the clinical trial.
Measured: At the time of enrollment, before the intubation procedure, assessed once per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infant, PrematureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups with 1:1 allocation ratio. Intervention group receives fentanyl plus rocuronium; control group receives fentanyl
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UEA - Universidade Do Estado Do Amazonas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jefferson Pereira Guilherme, UEA - Universidade Do Estado Do Amazonas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650552
- Sponsor's protocol ID
- NEORIN-2026-MAB/UEA
- Acronym
- NEORIN
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin JD, Fang WF, Tang KT, Cheng CW. Effects of exogenous melatonin on clinical and pathological features of a human thyroglobulin-induced experimental autoimmune thyroiditis mouse model. Sci Rep. 2019 Apr 10;9(1):5886. doi: 10.1038/s41598-019-42442-0.
PubMed 30971749Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
PubMed 20966694Krick J, Gray M, Umoren R, Lee G, Sawyer T. Premedication with paralysis improves intubation success and decreases adverse events in very low birth weight infants: a prospective cohort study. J Perinatol. 2018 Jun;38(6):681-686. doi: 10.1038/s41372-018-0082-2. Epub 2018 Feb 21.
PubMed 29467520Herrick HM, Glass KM, Johnston LC, Singh N, Shults J, Ades A, Nadkarni V, Nishisaki A, Foglia EE; for the NEAR4NEOS Investigators. Comparison of Neonatal Intubation Practice and Outcomes between the Neonatal Intensive Care Unit and Delivery Room. Neonatology. 2020;117(1):65-72. doi: 10.1159/000502611. Epub 2019 Sep 27.
PubMed 31563910Foglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, Quek BH, Johnston LC, Barry J, Zenge J, Moussa A, Kim JH, DeMeo SD, Napolitano N, Nadkarni V, Nishisaki A; NEAR4NEOS Investigators. Neonatal Intubation Practice and Outcomes: An International Registry Study. Pediatrics. 2019 Jan;143(1):e20180902. doi: 10.1542/peds.2018-0902. Epub 2018 Dec 11.
PubMed 30538147
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Association of Fentanyl and Rocuronium on First-Attempt Success Rate of Tracheal Intubation in Newborns: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07650552
- Acronym / sponsor ID
- NEORIN / NEORIN-2026-MAB/UEA
- Conditions
- Infant, Premature, Intubation, Intratracheal, Respiratory Distress Syndrome, Newborn, Apnea of Prematurity
- Keywords
- neonatal intubation, rocuronium, premedication, neuromuscular blocking agent, sugammadex, first-attempt success, NICU, newborn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- UEA - Universidade Do Estado Do AmazonasUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 16 Jun 2026 (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.
Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen desaturation, bradycardia, and airway trauma - are frequent. Premedication with neuromuscular blocking agents has been associated with improved intubation conditions and fewer adverse events in neonates.
This randomized, double-blind, parallel-group clinical trial (NEORIN) aims to evaluate whether the addition of rocuronium (0,6 mg/kg IV) to standard fentanyl premedication (1 mcg/kg IV) improves first-attempt success rates of tracheal intubation in newborns admitted to the NICU of Maternidade Ana Braga, Manaus, Brazil. The control group will receive fentanyl plus saline placebo. Sugammadex (16 mg/kg IV) is available as a reversal agent in case of prolonged neuromuscular blockade.
A secondary aim is to assess neonatologists' and residents' knowledge of and barriers to the use of neuromuscular blocking agents in neonatal intubation.
Detailed description
Neonatal tracheal intubation is performed in approximately 15-20% of NICU admissions. First-attempt success rates are approximately 49%, and adverse tracheal intubation-associated events (TIAEs) occur in up to 18% of procedures, with severe oxygen desaturation in up to 48% (NEAR4NEOS registry, Foglia et al., 2019). Premedication with neuromuscular blocking agents has been independently associated with a 62% reduction in adverse events (aOR 0.38; 95% CI 0.25-0.57).
Rocuronium is a non-depolarizing neuromuscular blocking agent with rapid onset, stable hemodynamic profile, and full reversibility with sugammadex, making it a safe choice for neonatal premedication.
The NEORIN trial will enroll 102 newborns (51 per group) with postnatal age ≤28 days or corrected gestational age <44 weeks, requiring non-emergent tracheal intubation. Randomization will be performed in variable-sized permuted blocks (4 and 6), with allocation concealment through sequential opaque sealed envelopes.
Intervention group: fentanyl 1 mcg/kg IV + rocuronium 0.6 mg/kg IV. Control group: fentanyl 1 mcg/kg IV + saline placebo (equivalent volume). Sugammadex is available at the bedside throughout the study as a mandatory safety requirement.
The primary composite outcome is first-attempt intubation success without physiological instability, defined as correct tube placement on the first laryngoscopy attempt confirmed by colorimetric CO2 detection, with no SpO2 drop >20% from baseline and no bradycardia (HR <100 bpm). All procedures will be video-recorded for blinded outcome assessment.
A secondary descriptive study will assess neonatologists' and residents' knowledge of and barriers to neuromuscular blocking agent use in neonatal intubation, using a structured questionnaire applied before the start of the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups with 1:1 allocation ratio. Intervention group receives fentanyl plus rocuronium; control group receives fentanyl
| Arm | Type | Receives |
|---|---|---|
| Fentanyl + Rocuronium | Experimental | Drug: Rocuronium Bromide 10 MG/MLFentanyl 1 mcg/kg IV followed by rocuronium 0.6 mg/kg IV, administered sequentially before non-emergent tracheal intubation. |
| Fentanyl Only | Active comparator | Drug: Rocuronium Bromide 10 MG/ML, Drug: Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation.Fentanyl 1 mcg/kg IV administered before non-emergent tracheal intubation, without neuromuscular blocking agent. |
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborns admitted to the NICU, ≤28 postnatal days OR corrected gestational age <44 weeks
- Indication for non-emergent orotracheal intubation (≥5 minutes between decision to intubate and start of laryngoscopy)
- Informed consent signed by legal guardians
Key exclusion criteria (8 listed)
- Upper airway malformations
- Use of neuromuscular blocking agent in the 24 hours prior to enrollment
- Known hypersensitivity to fentanyl or rocuronium
- Severe hemodynamic instability (ongoing shock)
- Anticipated difficult airway (micrognathia, cleft palate, or similar)
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 |
|---|---|---|
| Rocuronium Bromide 10 MG/MLRocuronium 0.6 mg/kg IV, single dose, administered as a bolus after fentanyl 1 mcg/kg IV, approximately 60 seconds before laryngoscopy | Drug | Fentanyl + Rocuronium, Fentanyl Only |
| Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation.Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation in both groups. | Drug | Fentanyl Only |
Primary outcome
First-attempt intubation success without physiological instability
Time frame: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Composite outcome defined as correct endotracheal tube placement on the first laryngoscopy attempt, confirmed by colorimetric CO2 detection, with no SpO2 drop greater than 20% from baseline and no bradycardia (heart rate below 100 bpm) of any duration. A new attempt is defined as removal and reinsertion of the laryngoscope blade into the oral cavity.
7 secondary outcomes
Total number of intubation attempts
Time frame: During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes)
Procedure duration
Time frame: From first laryngoscopy attempt to confirmation of endotracheal tube position, assessed during the intubation procedure (up to 5 minutes)
Severe oxygen desaturation
Time frame: During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes)
Bradycardia during intubation
Time frame: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Need for additional maneuvers
Time frame: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Medication-related adverse events
Time frame: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Knowledge and barriers to neuromuscular blocking agent use
Time frame: At the time of enrollment, before the intubation procedure, assessed once per participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 30971749Lin JD, Fang WF, Tang KT, Cheng CW. Effects of exogenous melatonin on clinical and pathological features of a human thyroglobulin-induced experimental autoimmune thyroiditis mouse model. Sci Rep. 2019 Apr 10;9(1):5886. doi: 10.1038/s41598-019-42442-0.
- Background: PubMed 20966694Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
- Background: PubMed 29467520Krick J, Gray M, Umoren R, Lee G, Sawyer T. Premedication with paralysis improves intubation success and decreases adverse events in very low birth weight infants: a prospective cohort study. J Perinatol. 2018 Jun;38(6):681-686. doi: 10.1038/s41372-018-0082-2. Epub 2018 Feb 21.
- Background: PubMed 31563910Herrick HM, Glass KM, Johnston LC, Singh N, Shults J, Ades A, Nadkarni V, Nishisaki A, Foglia EE; for the NEAR4NEOS Investigators. Comparison of Neonatal Intubation Practice and Outcomes between the Neonatal Intensive Care Unit and Delivery Room. Neonatology. 2020;117(1):65-72. doi: 10.1159/000502611. Epub 2019 Sep 27.
- Background: PubMed 30538147Foglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, Quek BH, Johnston LC, Barry J, Zenge J, Moussa A, Kim JH, DeMeo SD, Napolitano N, Nadkarni V, Nishisaki A; NEAR4NEOS Investigators. Neonatal Intubation Practice and Outcomes: An International Registry Study. Pediatrics. 2019 Jan;143(1):e20180902. doi: 10.1542/peds.2018-0902. Epub 2018 Dec 11.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium Bromide 10 MG/ML and Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation. in people with Infant, Premature and Intubation, Intratracheal, run by UEA - Universidade Do Estado Do Amazonas at 1 site in Brazil.
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 8 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: opening soon, as of the sponsor's last update on 1 Jul 2026. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JEFFERSON PEREIRA GUILHERME, M.D., Ph.D. candidate (+55 92981228890, jpguilherme@uea.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-attempt intubation success without physiological instability (time frame: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07650552, which also lists 5 linked publications.
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 1 Jul 2026.