Cerebral Blood FlowNCT07427342
Cerebral Blood Flow in Term and Preterm Neonates Using Doppler Ultrasonography
An observational study of Cerebral Blood Flow, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to evaluate cerebral blood flow in stable term and preterm newborns using Doppler ultrasonography. By measuring and comparing PSV, EDV, RI, and PI in the main brain arteries, the study seeks to identify normal physiological differences in cerebral perfusion across different gestational ages. Read more about this study
- Who is it for?
- Ages 1 hour to 48 hours
- Conditions the study is for
- Cerebral Blood Flow
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2026to 15 Dec 2027
- Phase
- Observational
- 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 hour to 48 hours
- All sexes
- Child
Study population: Term and Preterm Neonates
Who may be able to join
- Term neonates ≥ 37 weeks of gestational age.
- Preterm neonates < 37 weeks' gestational age.
- Hemodynamically stable infants at the time of examination.
- Parental/guardian informed consent obtained.
- Within the first 48 hours after birth.
- Birth weight appreciate for gestational age.
Who cannot join
- Infants aged more than 48 hours after birth.
- Neonates with major congenital anomalies (cardiac, neurological, or craniofacial).
- Suspected or confirmed intracranial hemorrhage or brain malformations, such as intraventricular hemorrhage, may influence RI measurements and interfere with accurate assessment of cerebral blood flow.
- Neonates requiring inotropic support at the time of scan.
- Neonates with severe respiratory instability or mechanical ventilation (unless included intentionally).
- Infants with sepsis or metabolic derangements affecting cerebral perfusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mostafa Ahmed Sayed, Lecturer contact
About this study
Official title: Comparative Analysis of Cerebral Blood Flow in Term and Preterm Neonates Using Doppler Ultrasonography
This study aims to evaluate cerebral blood flow in stable term and preterm newborns using Doppler ultrasonography. By measuring and comparing PSV, EDV, RI, and PI in the main brain arteries, the study seeks to identify normal physiological differences in cerebral perfusion across different gestational ages. The main goal is to establish reference values that can guide clinical monitoring, allow early detection of blood flow problems, and improve neuroprotective care in newborns.
Read the detailed description
The brain is a very active organ that needs a constant and well-controlled blood flow to provide oxygen and nutrients for normal brain function, growth, and development. In newborns, ensuring proper blood flow to the brain is especially important to support fast brain growth and prevent damage. Even small changes in cerebral blood flow can lead to serious problems, such as bleeding inside the brain, lack of oxygen-related injury, or long-term developmental delays. This risk is higher in preterm infants, whose ability to regulate brain blood flow is not fully developed and whose blood vessels are fragile. Therefore, accurately checking cerebral blood flow is crucial for monitoring brain health in newborns and for planning timely medical care.
Term and preterm newborns show clear differences in brain blood vessel function. In term infants, the brain's blood flow regulation is fairly mature, allowing vessels to change their size in response to blood pressure and metabolic needs, which helps keep blood flow stable. Preterm infants, especially those born before 32 weeks of gestation, have underdeveloped and often unstable regulation of cerebral blood flow. Their brain blood vessels rely heavily on blood pressure, making them more likely to suffer from reduced blood flow during low blood pressure or bleeding during high blood flow. These physiological differences highlight the importance of studying cerebral blood flow patterns at different gestational ages.
The preterm brain is not fully developed, both structurally and functionally. It has immature myelination, thin-walled blood vessels, and high energy needs. Any disruption in cerebral blood flow can quickly cause nerve cell injury, white matter damage, and long-term developmental problems. Medical conditions such as patent ductus arteriosus, respiratory distress, anemia, and sepsis can further affect brain blood flow.
Therefore, reliable monitoring methods are essential to detect early changes in blood flow and to guide protective care for the developing brain in these vulnerable infants.
Doppler ultrasonography is a safe, non-invasive bedside tool for assessing brain blood flow in newborns. Using the anterior fontanelle and temporal approach as a window provides real-time measurements of blood flow speeds in the main brain vessels (anterior, middle cerebral artery), which have therefore been the primary focus of most neonatal Doppler studies. Unlike MRI or CT, Doppler Ultrasonography does not require sedation or expose infants to radiation, which makes it suitable for repeated examinations. This technique is especially useful for preterm infants, as frequent monitoring is important to identify early abnormalities in brain circulation.
Key Doppler measurements include Peak Systolic Velocity (PSV), End-Diastolic Velocity (EDV), the Resistive Index (RI = (PSV - EDV)/PSV), and Pulsatility Index (PI= (PSV - EDV)/ Time Averaged Mean Velocity (TAMV)). PSV represents blood flow during systole and reflects cardiac output, EDV reflects diastolic flow and the resistance in the vessels, and RI indicates downstream resistance and the flexibility of cerebral vessels. PI quantifies the shape of the blood flow waveform, reflecting how much the flow changes throughout the cardiac cycle.
Preterm infants usually have higher RI and lower EDV, indicating immature vessel tone and increased resistance. Comparing these values between term and preterm newborns provides important information about developmental differences in brain blood flow.
Although assessing cerebral blood flow is clinically important, reported Doppler measurements vary widely between studies. Factors such as gestational age, birth weight, clinical condition, machine settings, angle of measurement, and examiner experience all contribute to these differences. Many earlier studies included medically unstable newborns, making interpretation more difficult. Therefore, well-designed and standardized studies are needed to establish reliable reference values and to support accurate clinical decisions and decrease comorbidity.
Assessing cerebral blood flow in both term and preterm newborns provides important information about normal brain development and helps distinguish between normal maturation and abnormal changes. Establishing reference values for Doppler measurements allows early detection of problems in brain circulation and supports timely interventions to protect neurodevelopment, especially in preterm infants.
- Conditions
- Cerebral Blood Flow
- Keywords
- Cerebral Blood Flow, Doppler Ultrasonography, Term and Preterm Neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Term Neonates | Normal Term neonates ≥ 37 weeks of gestational age | |
| Preterm Neonates | Normal Preterm neonates < 37 weeks' gestational age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resistive Index (RI)
RI = (PSV - EDV)/PSV, indicates downstream resistance and the flexibility of cerebral vessels
Measured: Baseline
Pulsatility Index (PI)
quantifies the shape of the blood flow waveform, reflecting how much the flow changes throughout the cardiac cycle.
Measured: Baseline
Peak Systolic Velocity (PSV)
represents blood flow during systole and reflects cardiac output
Measured: Baseline
End-Diastolic Velocity (EDV)
EDV reflects diastolic flow and the resistance in the vessels
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Dec 2027 (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 Cerebral Blood FlowStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sawsan Samy Aly Aly, Assiut University
- Investigators
- Hisham Mostafa Kamel, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427342
- Sponsor's protocol ID
- Doppler in Neonates
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
M. F. A. Ali, "Transcranial Doppler ultrasonography ( uses , limitations , and potentials ): a review article," 2021.
M. Ramadan, E. Kholy, and I. M. A. El-dayem, "Neonatal Hypoxic Ischemic Encephalopathy : Early Diagnosis and Outcome Prediction with Ultrasound," vol. 101, no. April 2024, pp. 5520-5526, 2025.
Camfferman FA, de Goederen R, Govaert P, Dudink J, van Bel F, Pellicer A, Cools F; eurUS.brain group. Diagnostic and predictive value of Doppler ultrasound for evaluation of the brain circulation in preterm infants: a systematic review. Pediatr Res. 2020 Mar;87(Suppl 1):50-58. doi: 10.1038/s41390-020-0777-x.
PubMed 32218536Vinci F, Tiseo M, Colosimo D, Calandrino A, Ramenghi LA, Biasucci DG. Point-of-care brain ultrasound and transcranial doppler or color-coded doppler in critically ill neonates and children. Eur J Pediatr. 2024 Mar;183(3):1059-1072. doi: 10.1007/s00431-023-05388-0. Epub 2023 Dec 19.
PubMed 38112802Bleton H, Perera S, Sejdic E. Cognitive tasks and cerebral blood flow through anterior cerebral arteries: a study via functional transcranial Doppler ultrasound recordings. BMC Med Imaging. 2016 Mar 12;16:22. doi: 10.1186/s12880-016-0125-0.
PubMed 26969112Pan Y, Wan W, Xiang M, Guan Y. Transcranial Doppler Ultrasonography as a Diagnostic Tool for Cerebrovascular Disorders. Front Hum Neurosci. 2022 Apr 29;16:841809. doi: 10.3389/fnhum.2022.841809. eCollection 2022.
PubMed 35572008Jarmund AH, Pedersen SA, Torp H, Dudink J, Nyrnes SA. A Scoping Review of Cerebral Doppler Arterial Waveforms in Infants. Ultrasound Med Biol. 2023 Apr;49(4):919-936. doi: 10.1016/j.ultrasmedbio.2022.12.007. Epub 2023 Jan 31.
PubMed 36732150Rasulo FA, De Peri E, Lavinio A. Transcranial Doppler ultrasonography in intensive care. Eur J Anaesthesiol Suppl. 2008;42:167-73. doi: 10.1017/S0265021507003341.
PubMed 18289437Naqvi J, Yap KH, Ahmad G, Ghosh J. Transcranial Doppler ultrasound: a review of the physical principles and major applications in critical care. Int J Vasc Med. 2013;2013:629378. doi: 10.1155/2013/629378. Epub 2013 Dec 12.
PubMed 24455270Fichera G, Stramare R, Bisogno G, Wyttenbach R, Goeggel BS, Del Grande F, Giraudo C, Lacalamita MC. Neonatal cerebral ultrasound: anatomical variants and age-related diseases. J Ultrasound. 2024 Dec;27(4):993-1002. doi: 10.1007/s40477-024-00914-8. Epub 2024 Jun 25.
PubMed 38918318Lu Q, Lu YJ, Chen ZH, Cao CY, Wu W. Predictive value of transcranial Doppler ultrasound for brain development and craniocerebral injury in premature infants. Am J Transl Res. 2025 Mar 15;17(3):2076-2082. doi: 10.62347/QJZN6645. eCollection 2025.
PubMed 40225994Farag MM, Gouda MH, Almohsen AMA, Khalifa MA. Intraventricular hemorrhage prediction in premature neonates in the era of hemodynamics monitoring: a prospective cohort study. Eur J Pediatr. 2022 Dec;181(12):4067-4077. doi: 10.1007/s00431-022-04630-5. Epub 2022 Sep 28.
PubMed 36171508Kamel SM, Badr-Eldin RM, Arafat MM, Hashem RH. Role of transcranial Doppler in assessment of cerebral blood flow in full term neonates with extreme unconjugated hyperbilirubinemia. J Ultrasound. 2023 Mar;26(1):175-184. doi: 10.1007/s40477-022-00704-0. Epub 2022 Aug 15.
PubMed 35969370
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Cerebral Blood Flow in Term and Preterm Neonates Using Doppler Ultrasonography
- ClinicalTrials.gov ID
- NCT07427342
- Acronym / sponsor ID
- Doppler in Neonates
- Conditions
- Cerebral Blood Flow
- Keywords
- Cerebral Blood Flow, Doppler Ultrasonography, Term and Preterm Neonates
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 23 Feb 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.
This study aims to evaluate cerebral blood flow in stable term and preterm newborns using Doppler ultrasonography. By measuring and comparing PSV, EDV, RI, and PI in the main brain arteries, the study seeks to identify normal physiological differences in cerebral perfusion across different gestational ages. The main goal is to establish reference values that can guide clinical monitoring, allow early detection of blood flow problems, and improve neuroprotective care in newborns.
Detailed description
The brain is a very active organ that needs a constant and well-controlled blood flow to provide oxygen and nutrients for normal brain function, growth, and development. In newborns, ensuring proper blood flow to the brain is especially important to support fast brain growth and prevent damage. Even small changes in cerebral blood flow can lead to serious problems, such as bleeding inside the brain, lack of oxygen-related injury, or long-term developmental delays. This risk is higher in preterm infants, whose ability to regulate brain blood flow is not fully developed and whose blood vessels are fragile. Therefore, accurately checking cerebral blood flow is crucial for monitoring brain health in newborns and for planning timely medical care.
Term and preterm newborns show clear differences in brain blood vessel function. In term infants, the brain's blood flow regulation is fairly mature, allowing vessels to change their size in response to blood pressure and metabolic needs, which helps keep blood flow stable. Preterm infants, especially those born before 32 weeks of gestation, have underdeveloped and often unstable regulation of cerebral blood flow. Their brain blood vessels rely heavily on blood pressure, making them more likely to suffer from reduced blood flow during low blood pressure or bleeding during high blood flow. These physiological differences highlight the importance of studying cerebral blood flow patterns at different gestational ages.
The preterm brain is not fully developed, both structurally and functionally. It has immature myelination, thin-walled blood vessels, and high energy needs. Any disruption in cerebral blood flow can quickly cause nerve cell injury, white matter damage, and long-term developmental problems. Medical conditions such as patent ductus arteriosus, respiratory distress, anemia, and sepsis can further affect brain blood flow.
Therefore, reliable monitoring methods are essential to detect early changes in blood flow and to guide protective care for the developing brain in these vulnerable infants.
Doppler ultrasonography is a safe, non-invasive bedside tool for assessing brain blood flow in newborns. Using the anterior fontanelle and temporal approach as a window provides real-time measurements of blood flow speeds in the main brain vessels (anterior, middle cerebral artery), which have therefore been the primary focus of most neonatal Doppler studies. Unlike MRI or CT, Doppler Ultrasonography does not require sedation or expose infants to radiation, which makes it suitable for repeated examinations. This technique is especially useful for preterm infants, as frequent monitoring is important to identify early abnormalities in brain circulation.
Key Doppler measurements include Peak Systolic Velocity (PSV), End-Diastolic Velocity (EDV), the Resistive Index (RI = (PSV - EDV)/PSV), and Pulsatility Index (PI= (PSV - EDV)/ Time Averaged Mean Velocity (TAMV)). PSV represents blood flow during systole and reflects cardiac output, EDV reflects diastolic flow and the resistance in the vessels, and RI indicates downstream resistance and the flexibility of cerebral vessels. PI quantifies the shape of the blood flow waveform, reflecting how much the flow changes throughout the cardiac cycle.
Preterm infants usually have higher RI and lower EDV, indicating immature vessel tone and increased resistance. Comparing these values between term and preterm newborns provides important information about developmental differences in brain blood flow.
Although assessing cerebral blood flow is clinically important, reported Doppler measurements vary widely between studies. Factors such as gestational age, birth weight, clinical condition, machine settings, angle of measurement, and examiner experience all contribute to these differences. Many earlier studies included medically unstable newborns, making interpretation more difficult. Therefore, well-designed and standardized studies are needed to establish reliable reference values and to support accurate clinical decisions and decrease comorbidity.
Assessing cerebral blood flow in both term and preterm newborns provides important information about normal brain development and helps distinguish between normal maturation and abnormal changes. Establishing reference values for Doppler measurements allows early detection of problems in brain circulation and supports timely interventions to protect neurodevelopment, especially in preterm infants.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Term Neonates | – | –Normal Term neonates ≥ 37 weeks of gestational age |
| Preterm Neonates | – | –Normal Preterm neonates < 37 weeks' gestational age |
Who may qualify
- Ages
- 1 hour to 48 hours
- Sex
- All
- Age groups
- Child
- Study population
- Term and Preterm Neonates
Key inclusion criteria (6 listed)
- Term neonates ≥ 37 weeks of gestational age.
- Preterm neonates < 37 weeks' gestational age.
- Hemodynamically stable infants at the time of examination.
- Parental/guardian informed consent obtained.
- Within the first 48 hours after birth.
Key exclusion criteria (6 listed)
- Infants aged more than 48 hours after birth.
- Neonates with major congenital anomalies (cardiac, neurological, or craniofacial).
- Suspected or confirmed intracranial hemorrhage or brain malformations, such as intraventricular hemorrhage, may influence RI measurements and interfere with accurate assessment of cerebral blood flow.
- Neonates requiring inotropic support at the time of scan.
- Neonates with severe respiratory instability or mechanical ventilation (unless included intentionally).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resistive Index (RI)
Time frame: Baseline
RI = (PSV - EDV)/PSV, indicates downstream resistance and the flexibility of cerebral vessels
Pulsatility Index (PI)
Time frame: Baseline
quantifies the shape of the blood flow waveform, reflecting how much the flow changes throughout the cardiac cycle.
Peak Systolic Velocity (PSV)
Time frame: Baseline
represents blood flow during systole and reflects cardiac output
End-Diastolic Velocity (EDV)
Time frame: Baseline
EDV reflects diastolic flow and the resistance in the vessels
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 23 Feb 2026.
- BackgroundM. F. A. Ali, "Transcranial Doppler ultrasonography ( uses , limitations , and potentials ): a review article," 2021.
- BackgroundM. Ramadan, E. Kholy, and I. M. A. El-dayem, "Neonatal Hypoxic Ischemic Encephalopathy : Early Diagnosis and Outcome Prediction with Ultrasound," vol. 101, no. April 2024, pp. 5520-5526, 2025.
- Background: PubMed 32218536Camfferman FA, de Goederen R, Govaert P, Dudink J, van Bel F, Pellicer A, Cools F; eurUS.brain group. Diagnostic and predictive value of Doppler ultrasound for evaluation of the brain circulation in preterm infants: a systematic review. Pediatr Res. 2020 Mar;87(Suppl 1):50-58. doi: 10.1038/s41390-020-0777-x.
- Background: PubMed 38112802Vinci F, Tiseo M, Colosimo D, Calandrino A, Ramenghi LA, Biasucci DG. Point-of-care brain ultrasound and transcranial doppler or color-coded doppler in critically ill neonates and children. Eur J Pediatr. 2024 Mar;183(3):1059-1072. doi: 10.1007/s00431-023-05388-0. Epub 2023 Dec 19.
- Background: PubMed 26969112Bleton H, Perera S, Sejdic E. Cognitive tasks and cerebral blood flow through anterior cerebral arteries: a study via functional transcranial Doppler ultrasound recordings. BMC Med Imaging. 2016 Mar 12;16:22. doi: 10.1186/s12880-016-0125-0.
- Background: PubMed 35572008Pan Y, Wan W, Xiang M, Guan Y. Transcranial Doppler Ultrasonography as a Diagnostic Tool for Cerebrovascular Disorders. Front Hum Neurosci. 2022 Apr 29;16:841809. doi: 10.3389/fnhum.2022.841809. eCollection 2022.
- Background: PubMed 36732150Jarmund AH, Pedersen SA, Torp H, Dudink J, Nyrnes SA. A Scoping Review of Cerebral Doppler Arterial Waveforms in Infants. Ultrasound Med Biol. 2023 Apr;49(4):919-936. doi: 10.1016/j.ultrasmedbio.2022.12.007. Epub 2023 Jan 31.
- Background: PubMed 18289437Rasulo FA, De Peri E, Lavinio A. Transcranial Doppler ultrasonography in intensive care. Eur J Anaesthesiol Suppl. 2008;42:167-73. doi: 10.1017/S0265021507003341.
- Background: PubMed 24455270Naqvi J, Yap KH, Ahmad G, Ghosh J. Transcranial Doppler ultrasound: a review of the physical principles and major applications in critical care. Int J Vasc Med. 2013;2013:629378. doi: 10.1155/2013/629378. Epub 2013 Dec 12.
- Background: PubMed 38918318Fichera G, Stramare R, Bisogno G, Wyttenbach R, Goeggel BS, Del Grande F, Giraudo C, Lacalamita MC. Neonatal cerebral ultrasound: anatomical variants and age-related diseases. J Ultrasound. 2024 Dec;27(4):993-1002. doi: 10.1007/s40477-024-00914-8. Epub 2024 Jun 25.
- Background: PubMed 40225994Lu Q, Lu YJ, Chen ZH, Cao CY, Wu W. Predictive value of transcranial Doppler ultrasound for brain development and craniocerebral injury in premature infants. Am J Transl Res. 2025 Mar 15;17(3):2076-2082. doi: 10.62347/QJZN6645. eCollection 2025.
- Background: PubMed 36171508Farag MM, Gouda MH, Almohsen AMA, Khalifa MA. Intraventricular hemorrhage prediction in premature neonates in the era of hemodynamics monitoring: a prospective cohort study. Eur J Pediatr. 2022 Dec;181(12):4067-4077. doi: 10.1007/s00431-022-04630-5. Epub 2022 Sep 28.
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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.
Mostafa Ahmed Sayed, Lecturer contact
Hisham Mostafa Kamel, Professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Blood Flow, run by Assiut University at 1 site in Egypt.
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 6 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: opening soon, as of the sponsor's last update on 23 Feb 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 Egypt. 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 Sawsan Samy Aly Aly (01159860374, Sawsan.15235540@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resistive Index (RI) (time frame: Baseline). The study lists 4 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 NCT07427342, 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 23 Feb 2026.