Respiratory Distress SyndromePhase 4NCT04199364
Medium vs Low Oxygen Threshold for the Surfactant Administration
A Phase 4 study testing Poractant Alfa 80 mg/mL Intratracheal Suspension in people with Respiratory Distress Syndrome, run by Virgilio Paolo Carnielli.
Trial summary
The aim of this study will be to assess the better fraction inspired oxygen (FiO2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (RDS) randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. Read more about this study
- Who is it for?
- Ages 24 to 32 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Poractant Alfa 80 mg/mL Intratracheal Suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 30 Apr 2025
- Phase
- Phase 4
- 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 24 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age less than 32 weeks;
- diagnosis of respiratory distress (RDS);
- need for ventilatory support;
- written informed consent.
Who cannot join
- congenital malformations;
- genetic disorders;
- perinatal asphyxia.
- neonatal pneumonia or wet lung or meconium aspiration syndrome at birth.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Two Fraction Oxygen Inspired (FiO2) Thresholds for the Surfactant Administration in Preterm Infants With Respiratory Disease Syndrome: a Single-center Randomized Phase IV Clinical Trial
The aim of this study will be to assess the better fraction inspired oxygen (FiO2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (RDS) randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. The pulmonary gas-exchanges will be evaluated by oxygen saturation (SpO2) to FiO2 ratio (SFR) and will be used to define the better FiO2 threshold for the surfactant treatment.
Read the detailed description
Exogenous surfactant therapy is an effective treatment of neonatal respiratory distress syndrome (RDS) and has been associated with reduced severity of respiratory distress and mortality. The 2019 European guidelines for neonatal RDS treatment suggest as the threshold of inspired oxygen (FiO2) for the surfactant treatment at 30% for all gestational age, but there are no randomized studies that confirm this indication. Some observational studies reported that a relevant number of patients who are not routinely treated with surfactant had respiratory complications, thus they received exogenous surfactant. To date, the optimal FiO2 threshold for surfactant administration remains unclear.
In this single-center, randomized, phase 4 trial, preterm infants (gestational age<32 weeks) with RDS will be randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. According to the unit policy, the exogenous surfactant will be administered by an endotracheal tube in intubated infants, or by Intubation-Surfactant-Extubation (InSurE) / Less Invasive Surfactant Administration (LISA) methods in infants who will not remain intubated. The method used for the surfactant administration will be at the discretion of the caring physician.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Poractant Alfa 80 mg/mL Intratracheal Suspension
- Keywords
- RDS, Surfactant, Threshold, Oxygen, Preterm, Infant
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poractant Alfa 80 mg/mL Intratracheal SuspensionDrug
Exogenous surfactant (Poractant Alfa) administration at a dose of 200 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Low FiO2 threshold | Experimental | A fraction of inspired oxygen (FiO2) of 25% to have an oxygen saturation (SpO2) of 90-92%. Receives: Drug: Poractant Alfa 80 mg/mL Intratracheal Suspension |
| Medium FiO2 threshold | Experimental | A fraction of inspired oxygen (FiO2) of 35% to have an oxygen saturation (SpO2) of 90-92%. Receives: Drug: Poractant Alfa 80 mg/mL Intratracheal Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory pulmonary function
The oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2) ratio (SFR)
Measured: At day 3 of life
Secondary outcomes (9)
Endotracheal intubation
The need of endotracheal intubation after surfactant administration
Measured: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Oxygen therapy
The need of oxygen therapy
Measured: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory Support-1
The need of respiratory support
Measured: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory Support-1
Oxygenation index as indicator of the intensity of ventilatory
Measured: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory severity-1
Silvermann score as secondary respiratory severity index
Measured: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory severity-2
Lung ultrasound score (LUS) score as secondary respiratory severity index
Measured: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Long-term respiratory pulmonary function
The oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2) ratio (SFR)
Measured: At day 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first, and 1 year of corrected age
Complications of prematurity
The incidence of intraventricular hemorrhage of grade 3-4, periventricular leukomalacia, bronchopulmonary dysplasia, sepsis and retinopathy of prematurity
Measured: From birth to 36 weeks of postmenstrual age or discharge if it occurred first
In-hospital death
death before 36 weeks of gestation
Measured: From birth to 36 week of gestation or discharge if it occurred first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virgilio Paolo Carnielli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Virgilio Paolo Carnielli, Ospedali Riuniti Ancona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199364
- Sponsor's protocol ID
- 2535
- Other IDs
- 2019-002923-13, 2019
- Status last verified
- Apr 2021
- First submitted
- 12 Dec 2019
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
PubMed 30974433Engle WA; American Academy of Pediatrics Committee on Fetus and Newborn. Surfactant-replacement therapy for respiratory distress in the preterm and term neonate. Pediatrics. 2008 Feb;121(2):419-32. doi: 10.1542/peds.2007-3283.
PubMed 18245434Jobe AH. Pulmonary surfactant therapy. N Engl J Med. 1993 Mar 25;328(12):861-8. doi: 10.1056/NEJM199303253281208. No abstract available.
PubMed 8441430Ammari A, Suri M, Milisavljevic V, Sahni R, Bateman D, Sanocka U, Ruzal-Shapiro C, Wung JT, Polin RA. Variables associated with the early failure of nasal CPAP in very low birth weight infants. J Pediatr. 2005 Sep;147(3):341-7. doi: 10.1016/j.jpeds.2005.04.062.
PubMed 16182673Fuchs H, Lindner W, Leiprecht A, Mendler MR, Hummler HD. Predictors of early nasal CPAP failure and effects of various intubation criteria on the rate of mechanical ventilation in preterm infants of <29 weeks gestational age. Arch Dis Child Fetal Neonatal Ed. 2011 Sep;96(5):F343-7. doi: 10.1136/adc.2010.205898. Epub 2011 Jan 30.
PubMed 21278432Dargaville PA, Gerber A, Johansson S, De Paoli AG, Kamlin CO, Orsini F, Davis PG; Australian and New Zealand Neonatal Network. Incidence and Outcome of CPAP Failure in Preterm Infants. Pediatrics. 2016 Jul;138(1):e20153985. doi: 10.1542/peds.2015-3985.
PubMed 27365307Pillai MS, Sankar MJ, Mani K, Agarwal R, Paul VK, Deorari AK. Clinical prediction score for nasal CPAP failure in pre-term VLBW neonates with early onset respiratory distress. J Trop Pediatr. 2011 Aug;57(4):274-9. doi: 10.1093/tropej/fmq047. Epub 2010 Jun 16.
PubMed 20558382Dargaville PA, Aiyappan A, De Paoli AG, Dalton RG, Kuschel CA, Kamlin CO, Orsini F, Carlin JB, Davis PG. Continuous positive airway pressure failure in preterm infants: incidence, predictors and consequences. Neonatology. 2013;104(1):8-14. doi: 10.1159/000346460. Epub 2013 Apr 4.
PubMed 23595061De Jaegere AP, van der Lee JH, Cante C, van Kaam AH. Early prediction of nasal continuous positive airway pressure failure in preterm infants less than 30 weeks gestation. Acta Paediatr. 2012 Apr;101(4):374-9. doi: 10.1111/j.1651-2227.2011.02558.x. Epub 2012 Jan 9.
PubMed 22150698Rocha G, Flor-de-Lima F, Proenca E, Carvalho C, Quintas C, Martins T, Freitas A, Paz-Dias C, Silva A, Guimaraes H. Failure of early nasal continuous positive airway pressure in preterm infants of 26 to 30 weeks gestation. J Perinatol. 2013 Apr;33(4):297-301. doi: 10.1038/jp.2012.110. Epub 2012 Aug 30.
PubMed 22935774Gulczynska E, Szczapa T, Hozejowski R, Borszewska-Kornacka MK, Rutkowska M. Fraction of Inspired Oxygen as a Predictor of CPAP Failure in Preterm Infants with Respiratory Distress Syndrome: A Prospective Multicenter Study. Neonatology. 2019;116(2):171-178. doi: 10.1159/000499674. Epub 2019 May 21.
PubMed 31112987Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.
PubMed 27649091Walsh BK, Daigle B, DiBlasi RM, Restrepo RD; American Association for Respiratory Care. AARC Clinical Practice Guideline. Surfactant replacement therapy: 2013. Respir Care. 2013 Feb;58(2):367-75. doi: 10.4187/respcare.02189.
PubMed 23359726McCord FB, Curstedt T, Halliday HL, McClure G, Reid MM, Robertson B. Surfactant treatment and incidence of intraventricular haemorrhage in severe respiratory distress syndrome. Arch Dis Child. 1988 Jan;63(1):10-6. doi: 10.1136/adc.63.1.10.
PubMed 3279916Narendran V, Donovan EF, Hoath SB, Akinbi HT, Steichen JJ, Jobe AH. Early bubble CPAP and outcomes in ELBW preterm infants. J Perinatol. 2003 Apr-May;23(3):195-9. doi: 10.1038/sj.jp.7210904.
PubMed 12732855
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Fraction Oxygen Inspired (FiO2) Thresholds for the Surfactant Administration in Preterm Infants With Respiratory Disease Syndrome: a Single-center Randomized Phase IV Clinical Trial
- ClinicalTrials.gov ID
- NCT04199364
- Acronym / sponsor ID
- 2535
- Conditions
- Respiratory Distress Syndrome
- Keywords
- RDS, Surfactant, Threshold, Oxygen, Preterm, Infant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Virgilio Paolo CarnielliUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 13 Dec 2019 (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.
The aim of this study will be to assess the better fraction inspired oxygen (FiO2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (RDS) randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. The pulmonary gas-exchanges will be evaluated by oxygen saturation (SpO2) to FiO2 ratio (SFR) and will be used to define the better FiO2 threshold for the surfactant treatment.
Detailed description
Exogenous surfactant therapy is an effective treatment of neonatal respiratory distress syndrome (RDS) and has been associated with reduced severity of respiratory distress and mortality. The 2019 European guidelines for neonatal RDS treatment suggest as the threshold of inspired oxygen (FiO2) for the surfactant treatment at 30% for all gestational age, but there are no randomized studies that confirm this indication. Some observational studies reported that a relevant number of patients who are not routinely treated with surfactant had respiratory complications, thus they received exogenous surfactant. To date, the optimal FiO2 threshold for surfactant administration remains unclear.
In this single-center, randomized, phase 4 trial, preterm infants (gestational age<32 weeks) with RDS will be randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. According to the unit policy, the exogenous surfactant will be administered by an endotracheal tube in intubated infants, or by Intubation-Surfactant-Extubation (InSurE) / Less Invasive Surfactant Administration (LISA) methods in infants who will not remain intubated. The method used for the surfactant administration will be at the discretion of the caring physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low FiO2 threshold | Experimental | Drug: Poractant Alfa 80 mg/mL Intratracheal SuspensionA fraction of inspired oxygen (FiO2) of 25% to have an oxygen saturation (SpO2) of 90-92%. |
| Medium FiO2 threshold | Experimental | Drug: Poractant Alfa 80 mg/mL Intratracheal SuspensionA fraction of inspired oxygen (FiO2) of 35% to have an oxygen saturation (SpO2) of 90-92%. |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- gestational age less than 32 weeks;
- diagnosis of respiratory distress (RDS);
- need for ventilatory support;
- written informed consent.
Key exclusion criteria (4 listed)
- congenital malformations;
- genetic disorders;
- perinatal asphyxia.
- neonatal pneumonia or wet lung or meconium aspiration syndrome at birth.
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 |
|---|---|---|
| Poractant Alfa 80 mg/mL Intratracheal SuspensionExogenous surfactant (Poractant Alfa) administration at a dose of 200 mg/kg. | Drug | Low FiO2 threshold, Medium FiO2 threshold |
Primary outcome
Respiratory pulmonary function
Time frame: At day 3 of life
The oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2) ratio (SFR)
9 secondary outcomes
Endotracheal intubation
Time frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Oxygen therapy
Time frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory Support-1
Time frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory Support-1
Time frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory severity-1
Time frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory severity-2
Time frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Long-term respiratory pulmonary function
Time frame: At day 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first, and 1 year of corrected age
Complications of prematurity
Time frame: From birth to 36 weeks of postmenstrual age or discharge if it occurred first
In-hospital death
Time frame: From birth to 36 week of gestation or discharge if it occurred first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Background: PubMed 30974433Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
- Background: PubMed 18245434Engle WA; American Academy of Pediatrics Committee on Fetus and Newborn. Surfactant-replacement therapy for respiratory distress in the preterm and term neonate. Pediatrics. 2008 Feb;121(2):419-32. doi: 10.1542/peds.2007-3283.
- Background: PubMed 8441430Jobe AH. Pulmonary surfactant therapy. N Engl J Med. 1993 Mar 25;328(12):861-8. doi: 10.1056/NEJM199303253281208. No abstract available.
- Background: PubMed 16182673Ammari A, Suri M, Milisavljevic V, Sahni R, Bateman D, Sanocka U, Ruzal-Shapiro C, Wung JT, Polin RA. Variables associated with the early failure of nasal CPAP in very low birth weight infants. J Pediatr. 2005 Sep;147(3):341-7. doi: 10.1016/j.jpeds.2005.04.062.
- Background: PubMed 21278432Fuchs H, Lindner W, Leiprecht A, Mendler MR, Hummler HD. Predictors of early nasal CPAP failure and effects of various intubation criteria on the rate of mechanical ventilation in preterm infants of <29 weeks gestational age. Arch Dis Child Fetal Neonatal Ed. 2011 Sep;96(5):F343-7. doi: 10.1136/adc.2010.205898. Epub 2011 Jan 30.
- Background: PubMed 27365307Dargaville PA, Gerber A, Johansson S, De Paoli AG, Kamlin CO, Orsini F, Davis PG; Australian and New Zealand Neonatal Network. Incidence and Outcome of CPAP Failure in Preterm Infants. Pediatrics. 2016 Jul;138(1):e20153985. doi: 10.1542/peds.2015-3985.
- Background: PubMed 20558382Pillai MS, Sankar MJ, Mani K, Agarwal R, Paul VK, Deorari AK. Clinical prediction score for nasal CPAP failure in pre-term VLBW neonates with early onset respiratory distress. J Trop Pediatr. 2011 Aug;57(4):274-9. doi: 10.1093/tropej/fmq047. Epub 2010 Jun 16.
- Background: PubMed 23595061Dargaville PA, Aiyappan A, De Paoli AG, Dalton RG, Kuschel CA, Kamlin CO, Orsini F, Carlin JB, Davis PG. Continuous positive airway pressure failure in preterm infants: incidence, predictors and consequences. Neonatology. 2013;104(1):8-14. doi: 10.1159/000346460. Epub 2013 Apr 4.
- Background: PubMed 22150698De Jaegere AP, van der Lee JH, Cante C, van Kaam AH. Early prediction of nasal continuous positive airway pressure failure in preterm infants less than 30 weeks gestation. Acta Paediatr. 2012 Apr;101(4):374-9. doi: 10.1111/j.1651-2227.2011.02558.x. Epub 2012 Jan 9.
- Background: PubMed 22935774Rocha G, Flor-de-Lima F, Proenca E, Carvalho C, Quintas C, Martins T, Freitas A, Paz-Dias C, Silva A, Guimaraes H. Failure of early nasal continuous positive airway pressure in preterm infants of 26 to 30 weeks gestation. J Perinatol. 2013 Apr;33(4):297-301. doi: 10.1038/jp.2012.110. Epub 2012 Aug 30.
- Background: PubMed 31112987Gulczynska E, Szczapa T, Hozejowski R, Borszewska-Kornacka MK, Rutkowska M. Fraction of Inspired Oxygen as a Predictor of CPAP Failure in Preterm Infants with Respiratory Distress Syndrome: A Prospective Multicenter Study. Neonatology. 2019;116(2):171-178. doi: 10.1159/000499674. Epub 2019 May 21.
- Background: PubMed 27649091Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Poractant Alfa 80 mg/mL Intratracheal Suspension in people with Respiratory Distress Syndrome, run by Virgilio Paolo Carnielli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 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: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Virgilio Carnielli, MD, PHD (0715962045, v.carnielli@staff.univpm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory pulmonary function (time frame: At day 3 of life). 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 NCT04199364, 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 19 Apr 2021.