Heart Defects, CongenitalNCT07059689
High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery
A study testing High Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV) in people with Heart Defects, Congenital and Intensive Care Units, Pediatric, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Heart Defects, Congenital, Intensive Care Units, Pediatric, Respiration, Artificial
- What is being tested?
- High Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Jun 2025to Dec 2025
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients under 18 years of age.
- Post-cardiac surgery patients in the CICU of Cipto Mangunkusumo National General Hospital
- Patients at high risk of extubation failure (e.g., young age, open sternotomy, mechanical ventilation >48 hours).
- Patients who pass the extubation readiness test and spontaneous breathing trial.
Who cannot join
- Diaphragmatic paralysis.
- Decreased consciousness.
- Neuromuscular disease.
- Pneumothorax without drainage.
- Airway obstruction.
- Patients with a tracheostomy.
- Unplanned extubation.
- Patient received PEEP (Positive End-Expiratory Pressure) >7 prior to extubation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Faculty of Medicine, University of Indonesia
Jakarta, DKI Jakarta, 10430
Head of Pediatric Emergency and Intensive Care Division, +62811747363, dr.yogiprawira@gmail.com
About this study
Official title: High Flow Nasal Cannula vs. Non-Invasive Ventilation in Post-Extubation Pediatric Cardiac Surgery Patients: A Randomized Controlled Trial
High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery
Read the detailed description
This study aims to compare the extubation success rate between the use of High Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV) in pediatric patients post-cardiac surgery at the Cipto Mangunkusumo National General Hospital. Additionally, this study seeks to identify factors influencing extubation failure in high-risk patient populations, compare CICU length of stay, sedation usage and COMFORT scale between patients receiving HFNC and those receiving NIV.
- Conditions
- Heart Defects, Congenital, Intensive Care Units, Pediatric, Respiration, Artificial, Extubation
- Being tested
- High Flow Nasal Cannula (HFNC), Non-Invasive Ventilation (NIV)
- Medical subject headings
- Heart Defects, Congenital, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Cannula (HFNC)Device
Participants in this arm will receive High Flow Nasal Cannula therapy using the Airvo™3 Nasal High Flow System immediately after planned extubation following cardiac surgery
Non-Invasive Ventilation (NIV)Device
Participants in this arm will receive Non-Invasive Ventilation (NIV) immediately after planned extubation following cardiac surgery. NIV will be delivered using standard ICU ventilator settings, with parameters tailored to each patient's clinical condition
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula | Experimental | Participants in this arm will receive High Flow Nasal Cannula (HFNC) therapy using the Airvo™3 Nasal High Flow System immediately following planned extubation after cardiac surgery. Receives: Device: High Flow Nasal Cannula (HFNC) |
| Non-Invasive Ventilation (NIV) | Active comparator | Participants in this arm will receive Non-Invasive Ventilation (NIV) immediately following planned extubation after cardiac surgery, in accordance with institutional protocols. Receives: Device: Non-Invasive Ventilation (NIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Requiring Reintubation Within 48 - 72 Hours Following Planned Extubation After Cardiac Surgery
Participants who require reintubation due to respiratory failure, clinical deterioration, or complications related to respiratory support will be recorded. This outcome will be compared between the HFNC and NIV groups to assess extubation success.
Measured: 72 hours post-extubation
Secondary outcomes (4)
Length of Stay in the Cardiac Intensive Care Unit (CICU)
The total number of days each participant remains in the CICU will be recorded and compared between the HFNC and NIV groups.
Measured: 1 month
Total Duration of Sedation Post-Extubation
The cumulative duration (in hours) of sedative medication administration following extubation, measured up to 72 hours post-extubation. Duration will be compared between the HFNC and NIV groups.
Measured: Up to 72 hours post-extubation
Total Dosage of Sedation Post-Extubation
The cumulative total dose (in milligrams) of sedative medications administered following extubation, measured up to 72 hours post-extubation. Dosage will be compared between the HFNC and NIV groups.
Measured: Up to 72 hours post-extubation
Change in COMFORT Scale Scores Post-Extubation
The COMFORT Behavioral Scale will be used to assess patient comfort and distress levels at 0, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-extubation. This scale includes multiple behavioral indicators such as alertness, agitation, crying, physical movement, muscle tone, and facial tension.
Scores range from 6 to 30, where higher scores indicate greater distress and lower scores indicate better comfort/sedation.
Measured: Up to 48 hours post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start5 Jun 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Model description
- This is a parallel-group randomized controlled trial involving two intervention arms. Pediatric patients post-cardiac surgery admitted to the Cardiac Intensive Care Unit (CICU) at Cipto Mangunkusumo National General Hospital will be randomly assigned in a 1:1 ratio to receive either High Flow Nasal Cannula (HFNC) therapy or Non-Invasive Ventilation (NIV) for post-extubation respiratory support. Each participant will receive only one type of intervention throughout the study.
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yogi Prawira, Universitas Indonesia
- Investigators
- Head of Pediatric Emergency and Intensive Care Divison, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059689
- Sponsor's protocol ID
- 24-04-0565
- Status last verified
- Jul 2025
- First submitted
- 19 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kuitunen I, Uimonen M. Noninvasive respiratory support preventing reintubation after pediatric cardiac surgery-A systematic review. Paediatr Anaesth. 2024 Mar;34(3):204-211. doi: 10.1111/pan.14808. Epub 2023 Dec 1.
PubMed 38041510Elmitwalli I, Abdelhady E, Kalsotra S, Gehred A, Tobias JD, Olbrecht VA. Use of high-flow nasal cannula versus other noninvasive ventilation techniques or conventional oxygen therapy for respiratory support following pediatric cardiac surgery: A systematic review and meta-analysis. Paediatr Anaesth. 2024 Jun;34(6):519-531. doi: 10.1111/pan.14866. Epub 2024 Feb 22.
PubMed 38389199Zhou SJ, Chen XH, Liu YY, Chen Q, Zheng YR, Zhang QL. Comparison of high-flow nasal cannula oxygenation and non-invasive ventilation for postoperative pediatric cardiac surgery: a meta-analysis. BMC Pulm Med. 2024 Feb 21;24(1):92. doi: 10.1186/s12890-024-02901-5.
PubMed 38383357McQueen M, Rojas J, Sun SC, Tero R, Ives K, Bednarek F, Owens L, Dysart K, Dungan G, Shaffer TH, Miller TL. Safety and Long Term Outcomes with High Flow Nasal Cannula Therapy in Neonatology: A Large Retrospective Cohort Study. J Pulm Respir Med. 2014 Dec;4(6):216. doi: 10.4172/2161-105X.1000216.
PubMed 26167395Mayfield S, Bogossian F, O'Malley L, Schibler A. High-flow nasal cannula oxygen therapy for infants with bronchiolitis: pilot study. J Paediatr Child Health. 2014 May;50(5):373-8. doi: 10.1111/jpc.12509. Epub 2014 Feb 25.
PubMed 24612137Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.
PubMed 29310868Demoule A, Chevret S, Carlucci A, Kouatchet A, Jaber S, Meziani F, Schmidt M, Schnell D, Clergue C, Aboab J, Rabbat A, Eon B, Guerin C, Georges H, Zuber B, Dellamonica J, Das V, Cousson J, Perez D, Brochard L, Azoulay E; oVNI Study Group; REVA Network (Research Network in Mechanical Ventilation). Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries. Intensive Care Med. 2016 Jan;42(1):82-92. doi: 10.1007/s00134-015-4087-4. Epub 2015 Oct 13.
PubMed 26464393Chang CJ, Chiang LL, Chen KY, Feng PH, Su CL, Hsu HS. High-Flow Nasal Cannula versus Noninvasive Positive Pressure Ventilation in Patients with Heart Failure after Extubation: An Observational Cohort Study. Can Respir J. 2020 Jul 3;2020:6736475. doi: 10.1155/2020/6736475. eCollection 2020.
PubMed 32714476Simeonov L, Pechilkov D, Kaneva A, McLellan MC, Jenkins K. Early extubation strategy after congenital heart surgery: 1-year single-centre experience. Cardiol Young. 2022 Mar;32(3):357-363. doi: 10.1017/S1047951121002067. Epub 2021 Jun 7.
PubMed 34092274Rooney SR, Mastropietro CW, Benneyworth B, Graham EM, Klugman D, Costello J, Ghanayem N, Zhang W, Banerjee M, Gaies M. Influence of Early Extubation Location on Outcomes Following Pediatric Cardiac Surgery. Pediatr Crit Care Med. 2020 Oct;21(10):e915-e921. doi: 10.1097/PCC.0000000000002452.
PubMed 32639473Miura S, Butt W, Thompson J, Namachivayam SP. Recurrent Extubation Failure Following Neonatal Cardiac Surgery Is Associated with Increased Mortality. Pediatr Cardiol. 2021 Jun;42(5):1149-1156. doi: 10.1007/s00246-021-02593-2. Epub 2021 Apr 17.
PubMed 33864485Miura S, Jardim PV, Butt W, Namachivayam SP. Extubation Failure and Major Adverse Events Secondary to Extubation Failure Following Neonatal Cardiac Surgery. Pediatr Crit Care Med. 2020 Dec;21(12):e1119-e1125. doi: 10.1097/PCC.0000000000002470.
PubMed 32804741Murni IK, Djer MM, Yanuarso PB, Putra ST, Advani N, Rachmat J, Perdana A, Sukardi R. Outcome of pediatric cardiac surgery and predictors of major complication in a developing country. Ann Pediatr Cardiol. 2019 Jan-Apr;12(1):38-44. doi: 10.4103/apc.APC_146_17.
PubMed 30745768
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula vs. Non-Invasive Ventilation in Post-Extubation Pediatric Cardiac Surgery Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07059689
- Acronym / sponsor ID
- 24-04-0565
- Conditions
- Heart Defects, Congenital, Intensive Care Units, Pediatric, Respiration, Artificial, Extubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Jul 2025 (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.
High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery
Detailed description
This study aims to compare the extubation success rate between the use of High Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV) in pediatric patients post-cardiac surgery at the Cipto Mangunkusumo National General Hospital. Additionally, this study seeks to identify factors influencing extubation failure in high-risk patient populations, compare CICU length of stay, sedation usage and COMFORT scale between patients receiving HFNC and those receiving NIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel-group randomized controlled trial involving two intervention arms. Pediatric patients post-cardiac surgery admitted to the Cardiac Intensive Care Unit (CICU) at Cipto Mangunkusumo National General Hospital will be randomly assigned in a 1:1 ratio to receive either High Flow Nasal Cannula (HFNC) therapy or Non-Invasive Ventilation (NIV) for post-extubation respiratory support. Each participant will receive only one type of intervention throughout the study.
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula | Experimental | Device: High Flow Nasal Cannula (HFNC)Participants in this arm will receive High Flow Nasal Cannula (HFNC) therapy using the Airvo™3 Nasal High Flow System immediately following planned extubation after cardiac surgery. |
| Non-Invasive Ventilation (NIV) | Active comparator | Device: Non-Invasive Ventilation (NIV)Participants in this arm will receive Non-Invasive Ventilation (NIV) immediately following planned extubation after cardiac surgery, in accordance with institutional protocols. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients under 18 years of age.
- Post-cardiac surgery patients in the CICU of Cipto Mangunkusumo National General Hospital
- Patients at high risk of extubation failure (e.g., young age, open sternotomy, mechanical ventilation >48 hours).
- Patients who pass the extubation readiness test and spontaneous breathing trial.
Key exclusion criteria (8 listed)
- Diaphragmatic paralysis.
- Decreased consciousness.
- Neuromuscular disease.
- Pneumothorax without drainage.
- Airway obstruction.
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 |
|---|---|---|
| High Flow Nasal Cannula (HFNC)Participants in this arm will receive High Flow Nasal Cannula therapy using the Airvo™3 Nasal High Flow System immediately after planned extubation following cardiac surgery | Device | High Flow Nasal Cannula |
| Non-Invasive Ventilation (NIV)Participants in this arm will receive Non-Invasive Ventilation (NIV) immediately after planned extubation following cardiac surgery. NIV will be delivered using standard ICU ventilator settings, with parameters tailored to each patient's clinical condition | Device | Non-Invasive Ventilation (NIV) |
Primary outcome
Number of Participants Requiring Reintubation Within 48 - 72 Hours Following Planned Extubation After Cardiac Surgery
Time frame: 72 hours post-extubation
Participants who require reintubation due to respiratory failure, clinical deterioration, or complications related to respiratory support will be recorded. This outcome will be compared between the HFNC and NIV groups to assess extubation success.
4 secondary outcomes
Length of Stay in the Cardiac Intensive Care Unit (CICU)
Time frame: 1 month
Total Duration of Sedation Post-Extubation
Time frame: Up to 72 hours post-extubation
Total Dosage of Sedation Post-Extubation
Time frame: Up to 72 hours post-extubation
Change in COMFORT Scale Scores Post-Extubation
Time frame: Up to 48 hours post-extubation
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 11 Jul 2025.
- Background: PubMed 38041510Kuitunen I, Uimonen M. Noninvasive respiratory support preventing reintubation after pediatric cardiac surgery-A systematic review. Paediatr Anaesth. 2024 Mar;34(3):204-211. doi: 10.1111/pan.14808. Epub 2023 Dec 1.
- Background: PubMed 38389199Elmitwalli I, Abdelhady E, Kalsotra S, Gehred A, Tobias JD, Olbrecht VA. Use of high-flow nasal cannula versus other noninvasive ventilation techniques or conventional oxygen therapy for respiratory support following pediatric cardiac surgery: A systematic review and meta-analysis. Paediatr Anaesth. 2024 Jun;34(6):519-531. doi: 10.1111/pan.14866. Epub 2024 Feb 22.
- Background: PubMed 38383357Zhou SJ, Chen XH, Liu YY, Chen Q, Zheng YR, Zhang QL. Comparison of high-flow nasal cannula oxygenation and non-invasive ventilation for postoperative pediatric cardiac surgery: a meta-analysis. BMC Pulm Med. 2024 Feb 21;24(1):92. doi: 10.1186/s12890-024-02901-5.
- Background: PubMed 26167395McQueen M, Rojas J, Sun SC, Tero R, Ives K, Bednarek F, Owens L, Dysart K, Dungan G, Shaffer TH, Miller TL. Safety and Long Term Outcomes with High Flow Nasal Cannula Therapy in Neonatology: A Large Retrospective Cohort Study. J Pulm Respir Med. 2014 Dec;4(6):216. doi: 10.4172/2161-105X.1000216.
- Background: PubMed 24612137Mayfield S, Bogossian F, O'Malley L, Schibler A. High-flow nasal cannula oxygen therapy for infants with bronchiolitis: pilot study. J Paediatr Child Health. 2014 May;50(5):373-8. doi: 10.1111/jpc.12509. Epub 2014 Feb 25.
- Background: PubMed 29310868Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.
- Background: PubMed 26464393Demoule A, Chevret S, Carlucci A, Kouatchet A, Jaber S, Meziani F, Schmidt M, Schnell D, Clergue C, Aboab J, Rabbat A, Eon B, Guerin C, Georges H, Zuber B, Dellamonica J, Das V, Cousson J, Perez D, Brochard L, Azoulay E; oVNI Study Group; REVA Network (Research Network in Mechanical Ventilation). Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries. Intensive Care Med. 2016 Jan;42(1):82-92. doi: 10.1007/s00134-015-4087-4. Epub 2015 Oct 13.
- Background: PubMed 32714476Chang CJ, Chiang LL, Chen KY, Feng PH, Su CL, Hsu HS. High-Flow Nasal Cannula versus Noninvasive Positive Pressure Ventilation in Patients with Heart Failure after Extubation: An Observational Cohort Study. Can Respir J. 2020 Jul 3;2020:6736475. doi: 10.1155/2020/6736475. eCollection 2020.
- Background: PubMed 34092274Simeonov L, Pechilkov D, Kaneva A, McLellan MC, Jenkins K. Early extubation strategy after congenital heart surgery: 1-year single-centre experience. Cardiol Young. 2022 Mar;32(3):357-363. doi: 10.1017/S1047951121002067. Epub 2021 Jun 7.
- Background: PubMed 32639473Rooney SR, Mastropietro CW, Benneyworth B, Graham EM, Klugman D, Costello J, Ghanayem N, Zhang W, Banerjee M, Gaies M. Influence of Early Extubation Location on Outcomes Following Pediatric Cardiac Surgery. Pediatr Crit Care Med. 2020 Oct;21(10):e915-e921. doi: 10.1097/PCC.0000000000002452.
- Background: PubMed 33864485Miura S, Butt W, Thompson J, Namachivayam SP. Recurrent Extubation Failure Following Neonatal Cardiac Surgery Is Associated with Increased Mortality. Pediatr Cardiol. 2021 Jun;42(5):1149-1156. doi: 10.1007/s00246-021-02593-2. Epub 2021 Apr 17.
- Background: PubMed 32804741Miura S, Jardim PV, Butt W, Namachivayam SP. Extubation Failure and Major Adverse Events Secondary to Extubation Failure Following Neonatal Cardiac Surgery. Pediatr Crit Care Med. 2020 Dec;21(12):e1119-e1125. doi: 10.1097/PCC.0000000000002470.
- 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.
Head of Pediatric Emergency and Intensive Care Divison principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV) in people with Heart Defects, Congenital and Intensive Care Units, Pediatric, run by Universitas Indonesia at 1 site in Indonesia.
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 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: looking for participants now, as of the sponsor's last update on 11 Jul 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 Indonesia. 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?
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 Head of Pediatric Emergency and Intensive Care Divison (+62811747363, dr.yogiprawira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Requiring Reintubation Within 48 - 72 Hours Following Planned Extubation After Cardiac Surgery (time frame: 72 hours post-extubation). 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 NCT07059689, which also lists 13 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 11 Jul 2025.