Hypoplastic Left Heart SyndromePhase 1CHILDNCT03406884

The CHILD Trial: Hypoplastic Left Heart Syndrome Study.

A Phase 1 study testing c-kit+ cells in people with Hypoplastic Left Heart Syndrome, run by Joshua M Hare at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objectives of this pilot study are to evaluate the feasibility and safety of intramyocardial injection of autologous c-kit+ cells during the Stage II Bidirectional Cavopulmonary Anastomosis (BDCPA) operation and to observe effects on clinical outcome including right ventricular myocardial function, severity of… Read more about this study

Who is it for?: Ages 1 day to 21 days
Conditions the study is for: Hypoplastic Left Heart Syndrome
What is being tested?: c-kit+ cells
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 4 sitesUnited States
Study dates: 16 Oct 2019to 1 Jul 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 days
All sexes
No healthy volunteers
Child

Who may be able to join

For inclusion in the study, subjects must meet all of the inclusion criteria:
Subjects with hypoplastic left heart syndrome (HLHS) (all types) requiring Stage I Norwood operation.

Who cannot join

Candidates will be excluded from the study if any of the following conditions are met:
Subjects undergoing the Stage I Norwood operation who do not have HLHS.
Subjects requiring mechanical circulatory support immediately prior to Stage II BDCPA operation (within 5 days).
Parent or guardian unwilling or unable to comply with necessary follow-up(s).
Mother is serum positive for HIV 1/2, hepatitis B surface antigen or viremic hepatitis C and Treponema pallidum.
Subjects who are unsuitable for inclusion in the study in the opinion of the investigator(s).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Michigan Medicine Congenital Heart Center/C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
Emory University Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, 30322
University of Maryland - Division of Cardiac Surgery
Baltimore, Maryland, 21201
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Autologous Cardiac Stem Cell Injection in Patients With Hypoplastic Left Heart Syndrome: An Open Label Pilot Study.

Conditions: Hypoplastic Left Heart Syndrome
Being tested: c-kit+ cells
Keywords: stem cells, pediatric
Medical subject headings: Hypoplastic Left Heart Syndrome

What participants receive

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

c-kit+ cellsBiological
Also called Autologous c-kit-positive cells (c-kit+ cells)
The autologous c-kit+ cells will be harvested from participant's right atrial tissue obtained from participant's SOC Norwood Operation. The harvested c-kit+ cells containing up to a total of 12,500 cells/kg will be delivered through 6-10 intramyocardial injections of approximately 100uL per injection for a total volume of approximately 0.6 mL.

Study groups in NCT03406884
Study group	Role	What they receive
Open label C-kit+ cells Group A	Experimental	Group A is an open-label treatment group determining safety and feasibility. Participants enrolled in this group will be receiving previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially. Receives: Biological: c-kit+ cells
C-kit+ cells Group B	Active comparator	Participants randomized to Group B Treatment Group will receive previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially. Receives: Biological: c-kit+ cells
No Intervention Group	No intervention	Participants randomized to Group B Control Group will receive only their standard of care (SOC) Stage II BDCPA operation without the injection of harvested c-kit+ cells.

What is being measured

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

Number of Incidence of Treatment Related Major Adverse Cardiac Events
Safety will be reported as the number of incidence of treatment related major adverse cardiac events (MACE). MACE is defined as any of the following: greater than 30 seconds of sustained/symptomatic ventricular tachycardia requiring intervention, cardiogenic shock, unplanned cardiovascular operation due to injection site bleeding, need for new permanent pacemaker, stroke or embolic event to the brain determined by CT scan and death. MACE will be evaluated by the treating physician and assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
Measured: 30 days
Number of C-kit+ Products
Feasibility will be reported as the number of c-kit+ products that can be manufactured and delivered to subjects
Measured: Day 1
Number of Participants Completing Magnetic Resonance Imaging (MRI)
Feasibility will be reported as the number of participants that complete the baseline, 6-months, and 12-months follow up MRI.
Measured: Baseline, 6 Months, 12 months
Change in Right Ventricular Function (RVEF)
Efficacy will be reported as the change in right ventricular function assessed as a percentage and will be measuring using serial echocardiograms and MRI scan.
Measured: Baseline, 6 Months, 12 months
Change in Right Ventricular End-diastolic Volume (RVEDV)
Efficacy will be reported as the change in right ventricular end-diastolic assessed in milliliters per square meter and will be measured using serial echocardiograms and MRI scan.
Measured: Baseline, 6 months, 12 months
Change in Right Ventricular End-systolic Volume (RVESV)
Efficacy will be reported as the change in right ventricular end-systolic volume assessed in milliliters per square meter and will be measured using serial echocardiograms and MRI scan.
Measured: Baseline, 6 months, 12 months
Change in Tricuspid Regurgitation
Efficacy will be reported as the change tricuspid regurgitation assessed as a percentage and will be measured using serial echocardiograms and MRI scan.
Measured: Baseline, 6 months, 12 months

Secondary outcomes (6)

Number of Incidence of Serious Adverse Events
Incidence of the following after the BDCPA / GLENN Procedure including: All-cause mortality; Cardiovascular mortality; Need for transplantation; Hospitalization for heart failure; Cardiovascular morbidity, including stroke or heart failure or sustained/symptomatic arrhythmias.
Measured: Up to 12 months
Change in Somatic Growth Velocity - Length (cm)
Changes in somatic growth velocity will be evaluated by length (cm) over 12 months post study product injection.
Measured: Baseline, 6 months, 12 months
Change in Somatic Growth Velocity - Weight (kg)
Changes in somatic growth velocity will be evaluated by weight (kg) over 12 months post study product injection.
Measured: Baseline, 6 months, 12 months
Change in Somatic Growth Velocity - Head Circumference (cm)
Changes in somatic growth velocity will be evaluated by head circumference (cm) over 12 months post study product injection.
Measured: Baseline, 6 months, 12 months
Change in Infant Toddler Quality of Life Survey (ITQOL) - Overall Health
The Infant Toddler Quality of Life Survey (ITQOL) is a validated 47-item parent-reported questionnaire assessing multiple domains of child health, including overall health, physical abilities, growth and development, discomfort/pain, mood, and behavior. Domain scores are transformed to a 0-100 scale, where 0 reflects the poorest health-related quality of life and 100 reflects the best. Higher scores indicate better quality of life.
Measured: Baseline, 12 months
Incidence of Mortality or Need for Transplantation
Incidence of mortality or need for transplantation after the Stage II BDCPA operation will be reported
Measured: Up to 12 months

Timeline

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

16 Oct 20191 Jul 2024

First posted23 Jan 2018
Study start16 Oct 2019
Primary completion1 Jul 2024
Study completion1 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Hypoplastic Left Heart SyndromeStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The first 10 participants will be enrolled in Group A to assess safety and feasibility. An additional 22 participants will be enrolled in Group B and will be randomized to either the Treatment or Control Group.
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03406884
Sponsor's protocol ID: 20190743
Acronym: CHILD
Status last verified: Jan 2026
First submitted: 20 Dec 2017
Last updated: 23 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Kaushal S, Hare JM, Mahle WT, Khan A, Ohye RG, Slesnick TC, Chai PJ, Shashidharan S, Robinson JD, Jone PN, Doman T, Si MS, Lu JC, Bacallao K, Nettina AE, Lamazares R, Saltzman RG, Simpson LM, Li R, Bettencourt JE, Mansoor K, Davis BR, Deatrick KB, Yang J, Mishra R, Everett AD, Lai D, Davis ME. Phase I Randomized Study of Cardiac Stem Cells in Patients With Hypoplastic Left Heart Syndrome: The CHILD Trial. JACC Heart Fail. 2026 Jan;14(1):102723. doi: 10.1016/j.jchf.2025.102723. Epub 2025 Nov 19.
PubMed 41258851
Kaushal S, Hare JM, Shah AM, Pietris NP, Bettencourt JL, Piller LB, Khan A, Snyder A, Boyd RM, Abdullah M, Mishra R, Sharma S, Slesnick TC, Si MS, Chai PJ, Davis BR, Lai D, Davis ME, Mahle WT. Autologous Cardiac Stem Cell Injection in Patients with Hypoplastic Left Heart Syndrome (CHILD Study). Pediatr Cardiol. 2022 Oct;43(7):1481-1493. doi: 10.1007/s00246-022-02872-6. Epub 2022 Apr 8.
PubMed 35394149
Ali MK, Ichimura K, Spiekerkoetter E. Promising therapeutic approaches in pulmonary arterial hypertension. Curr Opin Pharmacol. 2021 Aug;59:127-139. doi: 10.1016/j.coph.2021.05.003. Epub 2021 Jun 30.
PubMed 34217109

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
RecruitingPhase 3
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Hypoplastic Left Heart Syndrome, Single Ventricle
RecruitingObservational study
Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease
Congenital Heart Disease, Cyanotic Congenital Heart Disease
Enrolling by invitation
Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
Hypoplastic Left Heart Syndrome
Active, not recruitingObservational study
Long-term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type
Heart Defects

All Hypoplastic Left Heart Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Autologous Cardiac Stem Cell Injection in Patients With Hypoplastic Left Heart Syndrome: An Open Label Pilot Study.
ClinicalTrials.gov ID: NCT03406884
Acronym / sponsor ID: CHILD / 20190743
Conditions: Hypoplastic Left Heart Syndrome
Keywords: stem cells, pediatric
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Joshua M HareUniversity, hospital or other
Study start: 16 Oct 2019 (actual)
Primary completion: 1 Jul 2024 (actual)
Study completion: 1 Jul 2024 (actual)
First posted: 23 Jan 2018 (actual)
Results: Posted 23 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: The first 10 participants will be enrolled in Group A to assess safety and feasibility. An additional 22 participants will be enrolled in Group B and will be randomized to either the Treatment or Control Group.

Arm	Type	Receives
Open label C-kit+ cells Group A	Experimental	Biological: c-kit+ cellsGroup A is an open-label treatment group determining safety and feasibility. Participants enrolled in this group will be receiving previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially.
C-kit+ cells Group B	Active comparator	Biological: c-kit+ cellsParticipants randomized to Group B Treatment Group will receive previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially.
No Intervention Group	No intervention	–Participants randomized to Group B Control Group will receive only their standard of care (SOC) Stage II BDCPA operation without the injection of harvested c-kit+ cells.

Who may qualify

Ages: 1 day to 21 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

For inclusion in the study, subjects must meet all of the inclusion criteria:

Key exclusion criteria (6 listed)

Candidates will be excluded from the study if any of the following conditions are met:

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
c-kit+ cellsAlso: Autologous c-kit-positive cells (c-kit+ cells)The autologous c-kit+ cells will be harvested from participant's right atrial tissue obtained from participant's SOC Norwood Operation. The harvested c-kit+ cells containing up to a total of 12,500 cells/kg will be delivered through 6-10 intramyocardial injections of approximately 100uL per injection for a total volume of approximately 0.6 mL.	Biological	C-kit+ cells Group B, Open label C-kit+ cells Group A

Primary outcome

Number of Incidence of Treatment Related Major Adverse Cardiac Events
Time frame: 30 days
Safety will be reported as the number of incidence of treatment related major adverse cardiac events (MACE). MACE is defined as any of the following: greater than 30 seconds of sustained/symptomatic ventricular tachycardia requiring intervention, cardiogenic shock, unplanned cardiovascular operation due to injection site bleeding, need for new permanent pacemaker, stroke or embolic event to the brain determined by CT scan and death. MACE will be evaluated by the treating physician and assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
Number of C-kit+ Products
Time frame: Day 1
Feasibility will be reported as the number of c-kit+ products that can be manufactured and delivered to subjects
Number of Participants Completing Magnetic Resonance Imaging (MRI)
Time frame: Baseline, 6 Months, 12 months
Feasibility will be reported as the number of participants that complete the baseline, 6-months, and 12-months follow up MRI.
Change in Right Ventricular Function (RVEF)
Time frame: Baseline, 6 Months, 12 months
Efficacy will be reported as the change in right ventricular function assessed as a percentage and will be measuring using serial echocardiograms and MRI scan.
Change in Right Ventricular End-diastolic Volume (RVEDV)
Time frame: Baseline, 6 months, 12 months
Efficacy will be reported as the change in right ventricular end-diastolic assessed in milliliters per square meter and will be measured using serial echocardiograms and MRI scan.
Change in Right Ventricular End-systolic Volume (RVESV)
Time frame: Baseline, 6 months, 12 months
Efficacy will be reported as the change in right ventricular end-systolic volume assessed in milliliters per square meter and will be measured using serial echocardiograms and MRI scan.
Change in Tricuspid Regurgitation
Time frame: Baseline, 6 months, 12 months
Efficacy will be reported as the change tricuspid regurgitation assessed as a percentage and will be measured using serial echocardiograms and MRI scan.

6 secondary outcomes

Number of Incidence of Serious Adverse Events
Time frame: Up to 12 months
Change in Somatic Growth Velocity - Length (cm)
Time frame: Baseline, 6 months, 12 months
Change in Somatic Growth Velocity - Weight (kg)
Time frame: Baseline, 6 months, 12 months
Change in Somatic Growth Velocity - Head Circumference (cm)
Time frame: Baseline, 6 months, 12 months
Change in Infant Toddler Quality of Life Survey (ITQOL) - Overall Health
Time frame: Baseline, 12 months
Incidence of Mortality or Need for Transplantation
Time frame: Up to 12 months

Results and safety

Results posted to the registry on 23 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open Label C-kit+ Cells Group A	9	9
C-kit+ Cells Group B	8	8
No Intervention Group	8	8

Primary outcome: Number of Incidence of Treatment Related Major Adverse Cardiac Events

Time frame: 30 days. Number. Unit: Events

Measure	Open Label C-kit+ Cells Group A n = 9	C-kit+ Cells Group B n = 8	No Intervention Group n = 8
Value	1	0	6

Primary outcome: Number of C-kit+ Products

Time frame: Day 1. Number. Unit: Products

Measure	Open Label C-kit+ Cells Group A n = 9	C-kit+ Cells Group B n = 8	No Intervention Group n = 8
Value	9	7	0

Primary outcome: Number of Participants Completing Magnetic Resonance Imaging (MRI)

Time frame: Baseline, 6 Months, 12 months. Count of participants. Unit: Participants

Measure	Open Label C-kit+ Cells Group A n = 9	C-kit+ Cells Group B n = 8	No Intervention Group n = 8
Baseline	9	7	7
Month 6	6	6	5
Month 12	6	6	2

Primary outcome: Change in Right Ventricular Function (RVEF)

Time frame: Baseline, 6 Months, 12 months. Mean (Standard Deviation). Unit: percentage

Measure	Open Label C-kit+ Cells Group A n = 9	C-kit+ Cells Group B n = 8	No Intervention Group n = 8
Baseline	49.33 (4.44)	55 (7.19)	45.4 (10.25)
Month 6	48 (3.63)	50.83 (6.74)	47 (6.86)
Month 12	44.67 (8.36)	49.83 (3.76)	48.5 (3.54)

Population analysed: sample size decreases due to attrition

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Label C-kit+ Cells Group A	8 of 9 (88.9%)	5 of 9 (55.6%)	0 of 9
C-kit+ Cells Group B	4 of 8 (50%)	6 of 8 (75%)	0 of 8
No Intervention Group	4 of 8 (50%)	6 of 8 (75%)	1 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41258851Kaushal S, Hare JM, Mahle WT, Khan A, Ohye RG, Slesnick TC, Chai PJ, Shashidharan S, Robinson JD, Jone PN, Doman T, Si MS, Lu JC, Bacallao K, Nettina AE, Lamazares R, Saltzman RG, Simpson LM, Li R, Bettencourt JE, Mansoor K, Davis BR, Deatrick KB, Yang J, Mishra R, Everett AD, Lai D, Davis ME. Phase I Randomized Study of Cardiac Stem Cells in Patients With Hypoplastic Left Heart Syndrome: The CHILD Trial. JACC Heart Fail. 2026 Jan;14(1):102723. doi: 10.1016/j.jchf.2025.102723. Epub 2025 Nov 19.
Derived from this study: PubMed 35394149Kaushal S, Hare JM, Shah AM, Pietris NP, Bettencourt JL, Piller LB, Khan A, Snyder A, Boyd RM, Abdullah M, Mishra R, Sharma S, Slesnick TC, Si MS, Chai PJ, Davis BR, Lai D, Davis ME, Mahle WT. Autologous Cardiac Stem Cell Injection in Patients with Hypoplastic Left Heart Syndrome (CHILD Study). Pediatr Cardiol. 2022 Oct;43(7):1481-1493. doi: 10.1007/s00246-022-02872-6. Epub 2022 Apr 8.
Derived from this study: PubMed 34217109Ali MK, Ichimura K, Spiekerkoetter E. Promising therapeutic approaches in pulmonary arterial hypertension. Curr Opin Pharmacol. 2021 Aug;59:127-139. doi: 10.1016/j.coph.2021.05.003. Epub 2021 Jun 30.
Interdisciplinary stem cell institute at the University of Miami websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Hypoplastic Left Heart Syndrome

RecruitingObservational study
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
RecruitingPhase 3
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Hypoplastic Left Heart Syndrome, Single Ventricle
RecruitingObservational study
Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease
Congenital Heart Disease, Cyanotic Congenital Heart Disease
Enrolling by invitation
Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
Hypoplastic Left Heart Syndrome
Active, not recruitingObservational study
Long-term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type
Heart Defects

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.

William Mahle, MD principal investigator

Emory University

Kristopher Deatrick, MD principal investigator

University of Maryland

Richard Ohye, MD principal investigator

Michigan Medicine Congenital Heart Center/C.S. Mott Children's Hospital

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing c-kit+ cells in people with Hypoplastic Left Heart Syndrome, run by Joshua M Hare at 4 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 6 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 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Incidence of Treatment Related Major Adverse Cardiac Events (time frame: 30 days). The study lists 7 primary outcomes in all. 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 NCT03406884, which also lists 3 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 23 Jan 2026.