White Matter InjuryNCT04508517
Brain White Matter Injury in Late Preterm Infants
An observational study of White Matter Injury, run by Shengjing Hospital at 1 site in China.
Trial summary
At 34 weeks, the brain weight of preterm infants is only 65% that of term infants, and the cortex volume is 53% that of term infants. Damage at this stage of development will also change the trajectory of specific processes in the development of neurons and glial cells, resulting in neurological dysfunction in… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- White Matter Injury
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Late preterm infants undergoing head MRI, who were hospitalized in Shengjing Hospital from 1st January 2009 to 31st December 2022, were enrolled in this study.
Who may be able to join
- MRI head examination with informed consent of guardian
- Age 34-36+6 weeks
Who cannot join
- Other encephalopathies or congenital abnormality of brain development except white matter injury were excluded
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Chen Chen, master, +8618940259088, youdrop@sina.com
About this study
Official title: A Cohort Study on the Etiology and Pathological Types of Brain White Matter Injury in Late Preterm Infants
At 34 weeks, the brain weight of preterm infants is only 65% that of term infants, and the cortex volume is 53% that of term infants. Damage at this stage of development will also change the trajectory of specific processes in the development of neurons and glial cells, resulting in neurological dysfunction in survivors.The incidence of cerebral palsy in late preterm infants is three times higher than in term infants, and about 25% lag behind term infants in learning, language and other neurodevelopment. At 34-37 weeks of gestation, oligodendrocytes are still late oligodendrocyte precursors and vascular development of the white matter area is immature, making the brain more prone to white matter injury (WMI).
Read the detailed description
1.1Patients Late preterm infants who were hospitalized in Shengjing Hospital from 1st January 2009 to 31st December 2022.
Risk factors prompting MRI evaluation included: (1) premature rupture of fetal membrane, intrauterine distress or placental abruption before delivery; (2) asphyxia, resuscitation and rescue history, circulatory dysfunction and infection during or after delivery; and (3) early convulsions.
1.2 Assessment of brain injury MRI scans were analyzed by a radiologist and a newborn pediatrician who were unfamiliar with the clinical history. WMI diagnosis was carried out as described by reference, with some improvements.
1.3 Collection of clinical data Data, including delivery by cesarean section, gestational hypertension, diabetes mellitus, premature rupture of membranes and placental abruption, were collected for the mothers. Gestational age, weight, gender, whether small for gestational age, Apgar score, resuscitation history, circulatory disorders, early-onset sepsis, convulsions, and MRI data were collected for the newborns.
History of resuscitation and rescue refers to positive pressure ventilation, tracheal intubation, chest compression or epinephrine application during labor; circulatory disorders include at least two of the following indicators: prolonged capillary filling time, hypotension, oliguria, increased heart rate and increased liver.
1.4 Instrumentation MRI of the head was performed using an Intera Achieva 3.0T MRI system (Philips, Best, Netherlands). All infants were scanned by conventional MRI and diffusion-weighted imaging (DWI). Because of the retrospective study design, there are differences in imaging schemes, sequences and parameters measured.
- Conditions
- White Matter Injury
- Keywords
- white matter injury;late preterm infants
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging evaluation of different types of white matter injury in late preterm infants
The number of participants of white matter injury in late preterm infants, number of late preterm infants with different degrees (mild, moderate, severe) white matter injury and the imaging and pathological characteristics of early white matter injury (within 2 weeks after birth) using T1WI,T2WI,DWI,SWI.
Measured: 2009.1-2022.12
Imaging differentiation of hemorrhagic and non hemorrhagic injuries
Using magnetic resonance technology, especially magnetic sensitivity, to identify and classify the cases of white matter injury in late preterm infants with or without hemorrhagic injury
Measured: 2009.1-2022.12
Number of late preterm infants and distribution of gray matter injury in late preterm infants with white matter injury
Using magnetic resonance technology, To determine the number of gray matter injuries (cortex, thalamus, basal ganglia, brainstem) in late preterm infants with white matter injury
Measured: 2009.1-2022.12
The number and distribution of PVL like injury in white matter injury of late preterm infants
Using magnetic resonance technology, to determine the probability of PVL-like injury in white matter injury of late preterm infants and which type and location are more prone to PVL-like outcomes
Measured: 2009.1-2022.12
Secondary outcomes (14)
Record of gestational age
To identify the high risk factors of brain white matter injury in late preterm infants，gestational age(weeks) of every late preterm infant will be recorded
Measured: 2009.1-2022.12
Record of weight
To identify the high risk factors of brain white matter injury in late preterm infants，weight(g) of every late preterm infant will be recorded
Measured: 2009.1-2022.12
Record of gender
To identify the high risk factors of brain white matter injury in late preterm infants， gender(male/female) of every late preterm infant will be recorded
Measured: 2009.1-2022.12
Record of small for gestational age
To identify the high risk factors of brain white matter injury in late preterm infants，whether small for gestational age(yes/no) of every late preterm infant will be recorded
Measured: 2009.1-2022.12
Record of apgar score
To identify the high risk factors of brain white matter injury in late preterm infants，Apgar score(1-10) of every late preterm infant will be recorded
Measured: 2009.1-2022.12
Number of resuscitation history
To identify the high risk factors of brain white matter injury in late preterm infants，resuscitation history(yes/no) of every late preterm infant will be recorded.History of resuscitation and rescue refers to positive pressure ventilation, tracheal intubation, chest compression or epinephrine application during labor
Measured: 2009.1-2022.12
Number of circulatory disorders
To identify the high risk factors of brain white matter injury in late preterm infants，circulatory disorders(yes/no) of every late preterm infant will be recorded.Circulatory disorders include at least two of the following indicators: prolonged capillary filling time, hypotension, oliguria, increased heart rate and increased liver.
Measured: 2009.1-2022.12
Number of early-onset sepsis
To identify the high risk factors of brain white matter injury in late preterm infants，early-onset sepsis(yes/no) of every late preterm infant will be recorded
Measured: 2009.1-2022.12
Number of convulsions
To identify the high risk factors of brain white matter injury in late preterm infants，convulsions(yes/no) of every late preterm infant will be recorded
Measured: 2009.1-2022.12
Record of delivery by cesarean section
To identify the high risk factors of brain white matter injury in late preterm infants，delivery by cesarean section(yes/no) of every mother will be recorded
Measured: 2009.1-2022.12
Number of gestational hypertension
To identify the high risk factors of brain white matter injury in late preterm infants，gestational hypertension(mmHg) of every mother will be recorded
Measured: 2009.1-2022.12
Number of diabetes mellitus
To identify the high risk factors of brain white matter injury in late preterm infants，diabetes mellitus(yes/no) of every mother will be recorded
Measured: 2009.1-2022.12
Number of premature rupture of membranes
To identify the high risk factors of brain white matter injury in late preterm infants，premature rupture of membranes(yes/no) of every mother will be recorded
Measured: 2009.1-2022.12
Number of placental abruption
To identify the high risk factors of brain white matter injury in late preterm infants，placental abruption(yes/no) of every mother will be recorded
Measured: 2009.1-2022.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study startJan 2009
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for White Matter InjuryStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Chen, Shengjing Hospital
- Investigators
- Jian Mao, doctor, Study director, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508517
- Sponsor's protocol ID
- DChen
- Status last verified
- Aug 2020
- First submitted
- 3 Aug 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing the imaging results.
Publications
Kinney HC. The near-term (late preterm) human brain and risk for periventricular leukomalacia: a review. Semin Perinatol. 2006 Apr;30(2):81-8. doi: 10.1053/j.semperi.2006.02.006.
PubMed 16731282Petrini JR, Dias T, McCormick MC, Massolo ML, Green NS, Escobar GJ. Increased risk of adverse neurological development for late preterm infants. J Pediatr. 2009 Feb;154(2):169-76. doi: 10.1016/j.jpeds.2008.08.020. Epub 2008 Dec 10.
PubMed 19081113Limperopoulos C, Soul JS, Gauvreau K, Huppi PS, Warfield SK, Bassan H, Robertson RL, Volpe JJ, du Plessis AJ. Late gestation cerebellar growth is rapid and impeded by premature birth. Pediatrics. 2005 Mar;115(3):688-95. doi: 10.1542/peds.2004-1169.
PubMed 15741373Guihard-Costa AM, Larroche JC. Differential growth between the fetal brain and its infratentorial part. Early Hum Dev. 1990 Jun;23(1):27-40. doi: 10.1016/0378-3782(90)90126-4.
PubMed 2209474Huppi PS, Warfield S, Kikinis R, Barnes PD, Zientara GP, Jolesz FA, Tsuji MK, Volpe JJ. Quantitative magnetic resonance imaging of brain development in premature and mature newborns. Ann Neurol. 1998 Feb;43(2):224-35. doi: 10.1002/ana.410430213.
PubMed 9485064Ballabh P, Braun A, Nedergaard M. Anatomic analysis of blood vessels in germinal matrix, cerebral cortex, and white matter in developing infants. Pediatr Res. 2004 Jul;56(1):117-24. doi: 10.1203/01.PDR.0000130472.30874.FF. Epub 2004 May 5.
PubMed 15128918Arrigoni F, Parazzini C, Righini A, Doneda C, Ramenghi LA, Lista G, Triulzi F. Deep medullary vein involvement in neonates with brain damage: an MR imaging study. AJNR Am J Neuroradiol. 2011 Dec;32(11):2030-6. doi: 10.3174/ajnr.A2687. Epub 2011 Sep 29.
PubMed 21960491Taoka T, Fukusumi A, Miyasaka T, Kawai H, Nakane T, Kichikawa K, Naganawa S. Structure of the Medullary Veins of the Cerebral Hemisphere and Related Disorders. Radiographics. 2017 Jan-Feb;37(1):281-297. doi: 10.1148/rg.2017160061.
PubMed 28076020Vilan A, Ribeiro JM, Reis C, Sampaio L. Deep Medullary Veins and Brain Injury. J Pediatr. 2018 Sep;200:290-290.e1. doi: 10.1016/j.jpeds.2018.03.051. Epub 2018 May 3. No abstract available.
PubMed 29731359du Plessis AJ. Cerebrovascular injury in premature infants: current understanding and challenges for future prevention. Clin Perinatol. 2008 Dec;35(4):609-41, v. doi: 10.1016/j.clp.2008.07.010.
PubMed 19026331Martinez-Biarge M, Groenendaal F, Kersbergen KJ, Benders MJ, Foti F, Cowan FM, de Vries LS. MRI Based Preterm White Matter Injury Classification: The Importance of Sequential Imaging in Determining Severity of Injury. PLoS One. 2016 Jun 3;11(6):e0156245. doi: 10.1371/journal.pone.0156245. eCollection 2016.
PubMed 27257863Ramenghi LA, Govaert P, Fumagalli M, Bassi L, Mosca F. Neonatal cerebral sinovenous thrombosis. Semin Fetal Neonatal Med. 2009 Oct;14(5):278-83. doi: 10.1016/j.siny.2009.07.010. Epub 2009 Aug 20.
PubMed 19699161Nakamura Y, Okudera T, Hashimoto T. Vascular architecture in white matter of neonates: its relationship to periventricular leukomalacia. J Neuropathol Exp Neurol. 1994 Nov;53(6):582-9. doi: 10.1097/00005072-199411000-00005.
PubMed 7964899Takashima S, Mito T, Ando Y. Pathogenesis of periventricular white matter hemorrhages in preterm infants. Brain Dev. 1986;8(1):25-30. doi: 10.1016/s0387-7604(86)80116-4.
PubMed 3486608Gould SJ, Howard S, Hope PL, Reynolds EO. Periventricular intraparenchymal cerebral haemorrhage in preterm infants: the role of venous infarction. J Pathol. 1987 Mar;151(3):197-202. doi: 10.1002/path.1711510307.
PubMed 3572613
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on the Etiology and Pathological Types of Brain White Matter Injury in Late Preterm Infants
- ClinicalTrials.gov ID
- NCT04508517
- Acronym / sponsor ID
- DChen
- Conditions
- White Matter Injury
- Keywords
- white matter injury;late preterm infants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Aug 2020 (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.
At 34 weeks, the brain weight of preterm infants is only 65% that of term infants, and the cortex volume is 53% that of term infants. Damage at this stage of development will also change the trajectory of specific processes in the development of neurons and glial cells, resulting in neurological dysfunction in survivors.The incidence of cerebral palsy in late preterm infants is three times higher than in term infants, and about 25% lag behind term infants in learning, language and other neurodevelopment. At 34-37 weeks of gestation, oligodendrocytes are still late oligodendrocyte precursors and vascular development of the white matter area is immature, making the brain more prone to white matter injury (WMI).
Detailed description
1.1Patients Late preterm infants who were hospitalized in Shengjing Hospital from 1st January 2009 to 31st December 2022.
Risk factors prompting MRI evaluation included: (1) premature rupture of fetal membrane, intrauterine distress or placental abruption before delivery; (2) asphyxia, resuscitation and rescue history, circulatory dysfunction and infection during or after delivery; and (3) early convulsions.
1.2 Assessment of brain injury MRI scans were analyzed by a radiologist and a newborn pediatrician who were unfamiliar with the clinical history. WMI diagnosis was carried out as described by reference, with some improvements.
1.3 Collection of clinical data Data, including delivery by cesarean section, gestational hypertension, diabetes mellitus, premature rupture of membranes and placental abruption, were collected for the mothers. Gestational age, weight, gender, whether small for gestational age, Apgar score, resuscitation history, circulatory disorders, early-onset sepsis, convulsions, and MRI data were collected for the newborns.
History of resuscitation and rescue refers to positive pressure ventilation, tracheal intubation, chest compression or epinephrine application during labor; circulatory disorders include at least two of the following indicators: prolonged capillary filling time, hypotension, oliguria, increased heart rate and increased liver.
1.4 Instrumentation MRI of the head was performed using an Intera Achieva 3.0T MRI system (Philips, Best, Netherlands). All infants were scanned by conventional MRI and diffusion-weighted imaging (DWI). Because of the retrospective study design, there are differences in imaging schemes, sequences and parameters measured.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Late preterm infants undergoing head MRI, who were hospitalized in Shengjing Hospital from 1st January 2009 to 31st December 2022, were enrolled in this study.
Key inclusion criteria (2 listed)
- MRI head examination with informed consent of guardian
- Age 34-36+6 weeks
Key exclusion criteria (1 listed)
- Other encephalopathies or congenital abnormality of brain development except white matter injury were excluded
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
Imaging evaluation of different types of white matter injury in late preterm infants
Time frame: 2009.1-2022.12
The number of participants of white matter injury in late preterm infants, number of late preterm infants with different degrees (mild, moderate, severe) white matter injury and the imaging and pathological characteristics of early white matter injury (within 2 weeks after birth) using T1WI,T2WI,DWI,SWI.
Imaging differentiation of hemorrhagic and non hemorrhagic injuries
Time frame: 2009.1-2022.12
Using magnetic resonance technology, especially magnetic sensitivity, to identify and classify the cases of white matter injury in late preterm infants with or without hemorrhagic injury
Number of late preterm infants and distribution of gray matter injury in late preterm infants with white matter injury
Time frame: 2009.1-2022.12
Using magnetic resonance technology, To determine the number of gray matter injuries (cortex, thalamus, basal ganglia, brainstem) in late preterm infants with white matter injury
The number and distribution of PVL like injury in white matter injury of late preterm infants
Time frame: 2009.1-2022.12
Using magnetic resonance technology, to determine the probability of PVL-like injury in white matter injury of late preterm infants and which type and location are more prone to PVL-like outcomes
14 secondary outcomes
Record of gestational age
Time frame: 2009.1-2022.12
Record of weight
Time frame: 2009.1-2022.12
Record of gender
Time frame: 2009.1-2022.12
Record of small for gestational age
Time frame: 2009.1-2022.12
Record of apgar score
Time frame: 2009.1-2022.12
Number of resuscitation history
Time frame: 2009.1-2022.12
Number of circulatory disorders
Time frame: 2009.1-2022.12
Number of early-onset sepsis
Time frame: 2009.1-2022.12
Number of convulsions
Time frame: 2009.1-2022.12
Record of delivery by cesarean section
Time frame: 2009.1-2022.12
Number of gestational hypertension
Time frame: 2009.1-2022.12
Number of diabetes mellitus
Time frame: 2009.1-2022.12
Number of premature rupture of membranes
Time frame: 2009.1-2022.12
Number of placental abruption
Time frame: 2009.1-2022.12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Results publication: PubMed 16731282Kinney HC. The near-term (late preterm) human brain and risk for periventricular leukomalacia: a review. Semin Perinatol. 2006 Apr;30(2):81-8. doi: 10.1053/j.semperi.2006.02.006.
- Results publication: PubMed 19081113Petrini JR, Dias T, McCormick MC, Massolo ML, Green NS, Escobar GJ. Increased risk of adverse neurological development for late preterm infants. J Pediatr. 2009 Feb;154(2):169-76. doi: 10.1016/j.jpeds.2008.08.020. Epub 2008 Dec 10.
- Results publication: PubMed 15741373Limperopoulos C, Soul JS, Gauvreau K, Huppi PS, Warfield SK, Bassan H, Robertson RL, Volpe JJ, du Plessis AJ. Late gestation cerebellar growth is rapid and impeded by premature birth. Pediatrics. 2005 Mar;115(3):688-95. doi: 10.1542/peds.2004-1169.
- Results publication: PubMed 2209474Guihard-Costa AM, Larroche JC. Differential growth between the fetal brain and its infratentorial part. Early Hum Dev. 1990 Jun;23(1):27-40. doi: 10.1016/0378-3782(90)90126-4.
- Results publication: PubMed 9485064Huppi PS, Warfield S, Kikinis R, Barnes PD, Zientara GP, Jolesz FA, Tsuji MK, Volpe JJ. Quantitative magnetic resonance imaging of brain development in premature and mature newborns. Ann Neurol. 1998 Feb;43(2):224-35. doi: 10.1002/ana.410430213.
- Results publication: PubMed 15128918Ballabh P, Braun A, Nedergaard M. Anatomic analysis of blood vessels in germinal matrix, cerebral cortex, and white matter in developing infants. Pediatr Res. 2004 Jul;56(1):117-24. doi: 10.1203/01.PDR.0000130472.30874.FF. Epub 2004 May 5.
- Results publication: PubMed 21960491Arrigoni F, Parazzini C, Righini A, Doneda C, Ramenghi LA, Lista G, Triulzi F. Deep medullary vein involvement in neonates with brain damage: an MR imaging study. AJNR Am J Neuroradiol. 2011 Dec;32(11):2030-6. doi: 10.3174/ajnr.A2687. Epub 2011 Sep 29.
- Results publication: PubMed 28076020Taoka T, Fukusumi A, Miyasaka T, Kawai H, Nakane T, Kichikawa K, Naganawa S. Structure of the Medullary Veins of the Cerebral Hemisphere and Related Disorders. Radiographics. 2017 Jan-Feb;37(1):281-297. doi: 10.1148/rg.2017160061.
- Results publication: PubMed 29731359Vilan A, Ribeiro JM, Reis C, Sampaio L. Deep Medullary Veins and Brain Injury. J Pediatr. 2018 Sep;200:290-290.e1. doi: 10.1016/j.jpeds.2018.03.051. Epub 2018 May 3. No abstract available.
- Results publication: PubMed 19026331du Plessis AJ. Cerebrovascular injury in premature infants: current understanding and challenges for future prevention. Clin Perinatol. 2008 Dec;35(4):609-41, v. doi: 10.1016/j.clp.2008.07.010.
- Results publication: PubMed 27257863Martinez-Biarge M, Groenendaal F, Kersbergen KJ, Benders MJ, Foti F, Cowan FM, de Vries LS. MRI Based Preterm White Matter Injury Classification: The Importance of Sequential Imaging in Determining Severity of Injury. PLoS One. 2016 Jun 3;11(6):e0156245. doi: 10.1371/journal.pone.0156245. eCollection 2016.
- Results publication: PubMed 19699161Ramenghi LA, Govaert P, Fumagalli M, Bassi L, Mosca F. Neonatal cerebral sinovenous thrombosis. Semin Fetal Neonatal Med. 2009 Oct;14(5):278-83. doi: 10.1016/j.siny.2009.07.010. Epub 2009 Aug 20.
- Individual participant dataSharing planned: No. Sharing the imaging results.
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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. This study is not recruiting at the moment.
Jian Mao, doctor study director
Shengjing Hospital
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 White Matter Injury, run by Shengjing Hospital at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Aug 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Chen, master (+8618940259088, youdrop@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging evaluation of different types of white matter injury in late preterm infants (time frame: 2009.1-2022.12). 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 NCT04508517, which also lists 22 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 Aug 2020.