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Cardiac Arrest (CA)OPTI-VENTNCT07114510

Optimal Ventilation for Cardiac Arrest

A study testing OPTI-VENT Bundle and Transition in people with Cardiac Arrest (CA), run by Children's Hospital of Philadelphia at 20 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Pediatric cardiac arrest is a life-threatening problem affecting >15,000 hospitalized children each year. Less than half of these children survive to hospital discharge, and neurologic morbidity is common among survivors. Read more about this study

Who is it for?
Ages 37 weeks to 18 years
Conditions the study is for
Cardiac Arrest (CA)
What is being tested?
OPTI-VENT Bundle and Transition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,530 participants
Where
20 sitesUnited States
Study dates
1 Oct 2025to 31 Mar 2030
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 37 weeks to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Invasive airway in place at the start of CPR or airway placed within the first 5 minutes
  • Received at least 1 minute of CPR.

Who cannot join

  • Lack of commitment to aggressive ICU therapies (e.g., CPR performed as part of end-of-life care.
  • Brain death determination prior to the CPR event.
  • Out-of-hospital cardiac arrest was the reason for initial admission to the hospital (known poor outcomes).
  • Supported by Veno-Arterial Extra Corporeal Membrane Oxygenation at the start of CPR

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

CHOP RSC Clinical Research Program Manager contact

215-590-1859

grahamk1@chop.edu

20 sites in 1 country

United States20 sites, 20 recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30303

    Stephanie Brown, 216-333-3806, stephanie.rachelle.brown@emory.edu

    Recruiting

  • Dell Children's Medical Center

    Austin, Texas, 78723

    Hunter Daigle, 512-550-7786, hunter.daigle@utexas.edu

    Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

    Catherine Ross, 785-766-7214, Catherine.Ross@childrens.harvard.edu

    Recruiting

  • UNC Children's Hospital

    Chapel Hill, North Carolina, 27599

    Afsaneh Pirzadeh, 919-889-3888, afsaneh_pirzadeh@med.unc.edu

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Daniel Loeb, 216-299-0004, Daniel.Loeb@cchmc.org

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    John Jennings, 614-722-4619, john.jennings@nationwidechildrens.org

    Recruiting

  • Medical City Children's Hospital

    Dallas, Texas, 75230

    Tia Raymond, 972-533-7175, tia.raymond@hcahealthcare.com

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Priscilla Yu, 241-456-1269, Priscilla.Yu@UTSouthwestern.edu

    Recruiting

  • Children's Hospital Colorado

    Denver, Colorado, 80045

    Lorel Huber, 314-805-7058, lorel.huber@childrenscolorado.org

    Recruiting

  • Riley Children's Health

    Indianapolis, Indiana, 46202

    Maria Frazier, 937-272-5832, mfrazier7@iuhealth.org

    Recruiting

  • Stead Family Children's Hospital

    Iowa City, Iowa, 52242

    Sarah Haskell, 319-353-6464, sarah-haskell@uiowa.edu

    Recruiting

  • Children's Wisconsin

    Milwaukee, Wisconsin, 53226

    Andrea Maxwell, 712-870-1959, amaxwell@mcw.edu

    Recruiting

  • Cohen Children's Medical Center

    New Hyde Park, New York, 11040

    Todd Sweberg, 718-470-3668, Tsweberg@northwell.edu

    Recruiting

  • CHOC

    Orange, California, 92868

    Jennifer Hayes, 909-614-3592, jhayes@choc.org

    Recruiting

  • Lucile Packard Children's Hospital Stanford

    Palo Alto, California, 94304

    Azadeh Fayazi, 650-721-4320, afayazi@stanford.edu

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Amanda O'Halloran, 508-692-7502, ohallorana@chop.edu

    Recruiting

  • Children's Hospital of Richmond at VCU

    Richmond, Virginia, 23219

    Michelle Olson, 804-628-5488, michelle.olson@vcuhealth.org

    Recruiting

  • Seattle Children's

    Seattle, Washington, 98105

    Joan Roberts, 206-987-5119, joan.roberts@seattlechildrens.org

    Recruiting

  • Washington University in St. Louis

    St Louis, Missouri, 63110

    Ashley Turner, 417-317-8830, ashley.turner@wustl.edu

    Recruiting

  • Nemours Children's Health

    Wilmington, Delaware, 19803

    Yosef Levenbrown, 201-390-4961, Yosef.Levenbrown@nemours.org

    Recruiting

Other trials in United States

About this study

Official title: OPTImal Ventilation to Improve Pediatric Cardiac Arrest Outcomes (OPTI-VENT)

Pediatric cardiac arrest is a life-threatening problem affecting >15,000 hospitalized children each year. Less than half of these children survive to hospital discharge, and neurologic morbidity is common among survivors. The objective of this study is to evaluate the effectiveness of the OPTI-VENT bundle to improve survival to discharge with favorable neurological outcome (Pediatric Cerebral Performance Category Score 1-2 or no change from baseline) among children receiving at least 1 minute of CPR.

Being tested
OPTI-VENT Bundle, Transition, None - control
Keywords
Pediatric
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OPTI-VENT BundleOther

    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise.

    Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations.

    Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.

  • TransitionOther

    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.

  • None - controlOther

    Control - no intervention

Study groups in NCT07114510
Study groupRoleWhat they receive
ControlExperimentalStandard ICU resuscitation practices throughout study
Receives: Other: None - control
OPTI-VENT BundleExperimentalProvider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
Receives: Other: OPTI-VENT Bundle
Site 5ExperimentalStudy enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
Receives: Other: OPTI-VENT Bundle; Other: Transition; Other: None - control
Site 6ExperimentalStudy enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
Receives: Other: OPTI-VENT Bundle; Other: Transition; Other: None - control
Site 7ExperimentalStudy enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
Receives: Other: OPTI-VENT Bundle; Other: Transition; Other: None - control
Site 8ExperimentalStudy enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
Receives: Other: OPTI-VENT Bundle; Other: Transition; Other: None - control
Site 9ExperimentalStudy enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
Receives: Other: OPTI-VENT Bundle; Other: Transition; Other: None - control
Site 10ExperimentalStudy enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
Receives: Other: OPTI-VENT Bundle; Other: Transition; Other: None - control
Site 11ExperimentalStudy enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
Receives: Other: OPTI-VENT Bundle; Other: Transition; Other: None - control
Site 12ExperimentalStudy enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
Receives: Other: OPTI-VENT Bundle; Other: Transition; Other: None - control
Site 13ExperimentalStudy enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
Receives: Other: OPTI-VENT Bundle; Other: Transition; Other: None - control
Site 14ExperimentalStudy enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
Receives: Other: OPTI-VENT Bundle; Other: Transition; Other: None - control
Site 15ExperimentalStudy enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
Receives: Other: OPTI-VENT Bundle; Other: Transition; Other: None - control
Site 16ExperimentalStudy enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
Receives: Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival with a favorable neurologic outcome

    Survival to hospital discharge with a favorable neurologic outcome (Pediatric Cerebral Performance Category (PCPC) score (scored on a scale of 1-6) at hospital discharge of 1 (normal), 2 (mild disability) or no worse than baseline). Percentage of subjects in control vs. intervention will be compared.

    Measured: From baseline (assessed prior to admission, or new in-hospital baseline assessed no more than 30 days prior to cardiac arrest for patients hospitalized >90 days) to the assessment at hospital discharge, estimated average of 6-12 months

Secondary outcomes (1)

  1. Ventilation rate

    Intra-arrest ventilation rate between 18 - 32 breaths per minute. Ventilation rate will be calculated as an event average, excluding the first two minutes of the event. Percentage of events achieving target in control vs. intervention will be compared.

    Measured: Two minutes after CPR start through end of CPR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2025
  2. Study start1 Oct 2025
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,530 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07114510
Sponsor's protocol ID
24-022623
Other IDs
1R01HD114622-01A1
Acronym
OPTI-VENT
Status last verified
Oct 2026
First submitted
31 Jul 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to make a public use dataset available on the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) at the conclusion of the study. The public use data set will contain a randomly generated subject identification number but will not contain any personal or site identifiers. The cleaned, item-level spreadsheet data for all variables will be shared openly. Final files used to generate specific analyses to answer the Specific Aims and related results will also be shared. All study documents will be made available along with the public use data set. The study protocol and statistical analysis plan will be shared publicly. To facilitate interpretation of the data, a data dictionary will be created, shared, and associated with the relevant datasets.

Publications

  • Jacobs I, Nadkarni V, Bahr J, Berg RA, Billi JE, Bossaert L, Cassan P, Coovadia A, D'Este K, Finn J, Halperin H, Handley A, Herlitz J, Hickey R, Idris A, Kloeck W, Larkin GL, Mancini ME, Mason P, Mears G, Monsieurs K, Montgomery W, Morley P, Nichol G, Nolan J, Okada K, Perlman J, Shuster M, Steen PA, Sterz F, Tibballs J, Timerman S, Truitt T, Zideman D; International Liason Committee on Resusitation. Cardiac arrest and cardiopulmonary resuscitation outcome reports: update and simplification of the Utstein templates for resuscitation registries. A statement for healthcare professionals from a task force of the international liaison committee on resuscitation (American Heart Association, European Resuscitation Council, Australian Resuscitation Council, New Zealand Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa). Resuscitation. 2004 Dec;63(3):233-49. doi: 10.1016/j.resuscitation.2004.09.008.

    PubMed 15582757

  • Niles DE, Dewan M, Zebuhr C, Wolfe H, Bonafide CP, Sutton RM, DiLiberto MA, Boyle L, Napolitano N, Morgan RW, Stinson H, Leffelman J, Nishisaki A, Berg RA, Nadkarni VM. A pragmatic checklist to identify pediatric ICU patients at risk for cardiac arrest or code bell activation. Resuscitation. 2016 Feb;99:33-7. doi: 10.1016/j.resuscitation.2015.11.017. Epub 2015 Dec 17.

    PubMed 26703460

  • Pollack MM, Holubkov R, Glass P, Dean JM, Meert KL, Zimmerman J, Anand KJ, Carcillo J, Newth CJ, Harrison R, Willson DF, Nicholson C; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Functional Status Scale: new pediatric outcome measure. Pediatrics. 2009 Jul;124(1):e18-28. doi: 10.1542/peds.2008-1987.

    PubMed 19564265

  • Pollack MM, Holubkov R, Funai T, Clark A, Moler F, Shanley T, Meert K, Newth CJ, Carcillo J, Berger JT, Doctor A, Berg RA, Dalton H, Wessel DL, Harrison RE, Dean JM, Jenkins TL. Relationship between the functional status scale and the pediatric overall performance category and pediatric cerebral performance category scales. JAMA Pediatr. 2014 Jul;168(7):671-6. doi: 10.1001/jamapediatrics.2013.5316.

    PubMed 24862461

  • Del Castillo J, Lopez-Herce J, Matamoros M, Canadas S, Rodriguez-Calvo A, Cechetti C, Rodriguez-Nunez A, Alvarez AC; Iberoamerican Pediatric Cardiac Arrest Study Network RIBEPCI. Hyperoxia, hypocapnia and hypercapnia as outcome factors after cardiac arrest in children. Resuscitation. 2012 Dec;83(12):1456-61. doi: 10.1016/j.resuscitation.2012.07.019. Epub 2012 Jul 25.

    PubMed 22841610

  • Berg RA, Sutton RM, Reeder RW, Berger JT, Newth CJ, Carcillo JA, McQuillen PS, Meert KL, Yates AR, Harrison RE, Moler FW, Pollack MM, Carpenter TC, Wessel DL, Jenkins TL, Notterman DA, Holubkov R, Tamburro RF, Dean JM, Nadkarni VM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN) PICqCPR (Pediatric Intensive Care Quality of Cardio-Pulmonary Resuscitation) Investigators. Association Between Diastolic Blood Pressure During Pediatric In-Hospital Cardiopulmonary Resuscitation and Survival. Circulation. 2018 Apr 24;137(17):1784-1795. doi: 10.1161/CIRCULATIONAHA.117.032270. Epub 2017 Dec 26.

    PubMed 29279413

  • Reeder RW, Girling A, Wolfe H, Holubkov R, Berg RA, Naim MY, Meert KL, Tilford B, Carcillo JA, Hamilton M, Bochkoris M, Hall M, Maa T, Yates AR, Sapru A, Kelly R, Federman M, Michael Dean J, McQuillen PS, Franzon D, Pollack MM, Siems A, Diddle J, Wessel DL, Mourani PM, Zebuhr C, Bishop R, Friess S, Burns C, Viteri S, Hehir DA, Whitney Coleman R, Jenkins TL, Notterman DA, Tamburro RF, Sutton RM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN). Improving outcomes after pediatric cardiac arrest - the ICU-Resuscitation Project: study protocol for a randomized controlled trial. Trials. 2018 Apr 3;19(1):213. doi: 10.1186/s13063-018-2590-y.

    PubMed 29615134

  • ICU-RESUS and Eunice Kennedy Shriver National Institute of Child Health; Human Development Collaborative Pediatric Critical Care Research Network Investigator Groups; Sutton RM, Wolfe HA, Reeder RW, Ahmed T, Bishop R, Bochkoris M, Burns C, Diddle JW, Federman M, Fernandez R, Franzon D, Frazier AH, Friess SH, Graham K, Hehir D, Horvat CM, Huard LL, Landis WP, Maa T, Manga A, Morgan RW, Nadkarni VM, Naim MY, Palmer CA, Schneiter C, Sharron MP, Siems A, Srivastava N, Tabbutt S, Tilford B, Viteri S, Berg RA, Bell MJ, Carcillo JA, Carpenter TC, Dean JM, Fink EL, Hall M, McQuillen PS, Meert KL, Mourani PM, Notterman D, Pollack MM, Sapru A, Wessel D, Yates AR, Zuppa AF. Effect of Physiologic Point-of-Care Cardiopulmonary Resuscitation Training on Survival With Favorable Neurologic Outcome in Cardiac Arrest in Pediatric ICUs: A Randomized Clinical Trial. JAMA. 2022 Mar 8;327(10):934-945. doi: 10.1001/jama.2022.1738.

    PubMed 35258533

  • Aufderheide TP, Sigurdsson G, Pirrallo RG, Yannopoulos D, McKnite S, von Briesen C, Sparks CW, Conrad CJ, Provo TA, Lurie KG. Hyperventilation-induced hypotension during cardiopulmonary resuscitation. Circulation. 2004 Apr 27;109(16):1960-5. doi: 10.1161/01.CIR.0000126594.79136.61. Epub 2004 Apr 5.

    PubMed 15066941

  • Aufderheide TP, Lurie KG. Death by hyperventilation: a common and life-threatening problem during cardiopulmonary resuscitation. Crit Care Med. 2004 Sep;32(9 Suppl):S345-51. doi: 10.1097/01.ccm.0000134335.46859.09.

    PubMed 15508657

  • Grieco DL, J Brochard L, Drouet A, Telias I, Delisle S, Bronchti G, Ricard C, Rigollot M, Badat B, Ouellet P, Charbonney E, Mancebo J, Mercat A, Savary D, Richard JM. Intrathoracic Airway Closure Impacts CO2 Signal and Delivered Ventilation during Cardiopulmonary Resuscitation. Am J Respir Crit Care Med. 2019 Mar 15;199(6):728-737. doi: 10.1164/rccm.201806-1111OC.

    PubMed 30257100

  • Chapman JD, Geneslaw AS, Babineau J, Sen AI. Improving Ventilation Rates During Pediatric Cardiopulmonary Resuscitation. Pediatrics. 2022 Sep 1;150(3):e2021053030. doi: 10.1542/peds.2021-053030.

    PubMed 36000325

  • Sutton RM, Niles D, Meaney PA, Aplenc R, French B, Abella BS, Lengetti EL, Berg RA, Helfaer MA, Nadkarni V. Low-dose, high-frequency CPR training improves skill retention of in-hospital pediatric providers. Pediatrics. 2011 Jul;128(1):e145-51. doi: 10.1542/peds.2010-2105. Epub 2011 Jun 6.

    PubMed 21646262

  • Sutton RM, Reeder RW, Landis WP, Meert KL, Yates AR, Morgan RW, Berger JT, Newth CJ, Carcillo JA, McQuillen PS, Harrison RE, Moler FW, Pollack MM, Carpenter TC, Notterman DA, Holubkov R, Dean JM, Nadkarni VM, Berg RA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN). Ventilation Rates and Pediatric In-Hospital Cardiac Arrest Survival Outcomes. Crit Care Med. 2019 Nov;47(11):1627-1636. doi: 10.1097/CCM.0000000000003898.

    PubMed 31369424

  • Topjian AA, Raymond TT, Atkins D, Chan M, Duff JP, Joyner BL Jr, Lasa JJ, Lavonas EJ, Levy A, Mahgoub M, Meckler GD, Roberts KE, Sutton RM, Schexnayder SM; Pediatric Basic and Advanced Life Support Collaborators. Part 4: Pediatric Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S469-S523. doi: 10.1161/CIR.0000000000000901. Epub 2020 Oct 21. No abstract available.

    PubMed 33081526

Questions about this trial

What is this clinical trial studying?

A study testing OPTI-VENT Bundle and Transition in people with Cardiac Arrest (CA), run by Children's Hospital of Philadelphia at 20 sites in United States.

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 2 inclusion and 4 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. 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 CHOP RSC Clinical Research Program Manager (215-590-1859, grahamk1@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival with a favorable neurologic outcome (time frame: From baseline (assessed prior to admission, or new in-hospital baseline assessed no more than 30 days prior to cardiac arrest for patients hospitalized >90 days) to the assessment at hospital discharge, estimated average of 6-12 months). 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 NCT07114510, which also lists 19 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 21 Oct 2026.

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