Respiratory Distress SyndromeMASTERNCT05908227
Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants
A study testing NHF high, NHF low and NCPAP in people with Respiratory Distress Syndrome, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.
Trial summary
Premature babies often need help breathing for a longer period of time. Traditionally, this is done with a breathing aid called NCPAP (nasal continuous positive airway pressure). This treatment is safe and effective, but it is very time-consuming and can sometimes have side effects. Read more about this study
- Who is it for?
- Ages 23 to 31 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- NHF high, NHF low and NCPAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jul 2023to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants up to 31+6 weeks GA admitted to the Division of Neonatology at Inselspital Bern, Switzerland or Division of Neonatology at the University Medical Center of the Johannes Gutenberg-University Mainz, Germany (inborn or outborn)
- >2nd day of life (defined as date day)
- Stable on NCPAP 6 cm H2O for ≥ 24 hours, defined as:
- ≤ 2 apneas with concomitant bradycardias (<100/min) per hour for the previous 6 hours
- FiO2 ≤ 0.3 and not increasing
- No significant chest recessions (Silverman Score < 5)
Show all 10Show fewer
- Respiratory rate ≤ 60/min
- No need for intermittent positive pressure ventilation
- Parents with an age 18+ years
- Written parental informed consent (or other legal representative)
Who cannot join
- Significant fetal anomalies
- Primary palliative care
- Stable on NCPAP 6 cm H2O according to stability criteria for more than 120 hours
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, 55131
Susanne Tippmann, Dr. med., +49 6131 17 5892, Susanne.Tippmann@unimedizin-mainz.de
Susanne Tippmann, Dr. med.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Inselspital
Bern, 3010
Lisa M Bünte, +41316321923, lisamarie.buente@insel.ch
André Kidszun, Prof. Dr. med., +41 31 632 14 01, andre.kidszun@insel.ch
About this study
Official title: Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants (MASTER Trial)
Premature babies often need help breathing for a longer period of time. Traditionally, this is done with a breathing aid called NCPAP (nasal continuous positive airway pressure). This treatment is safe and effective, but it is very time-consuming and can sometimes have side effects. In the present research project, the investigators want to find out whether another type of breathing aid called NHF (nasal high flow therapy) is just as effective for stable premature babies. The investigators suspect that NHF is just as effective, but easier to use and more comfortable.
Read the detailed description
This is a multi center parallel group three arm randomized controlled clinical trial investigating cardiorespiratory stability in stable preterm infants receiving NHF.
Currently, NCPAP remains the gold standard for administration of prolonged non-invasive ventilatory support in very preterm infants. NHF is a promising method for tailored, less invasive long-term ventilatory support for preterm infants. If ventilatory support with NHF is similarly effective to conventional NCPAP in stable preterm infants, clinicians are likely to adopt this method for widespread clinical use because of its improved comfort and potential other benefits. Primary aim of this trial is to examine cardiorespiratory stability in preterm infants treated with two commonly used NHF flowrates (Interventional group 1 and 2) in comparison to NCPAP (Comparator). Secondary aim is to examine potential comfort-related beneficial effects of NHF.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- NHF high, NHF low, NCPAP
- Keywords
- Nasal high flow therapy, Continuous positive airway pressure
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHF highOther
Nasal high flow therapy 8L/min.
NHF lowOther
Nasal high flow therapy 6L/min.
NCPAPOther
Nasal continuous positive airway pressure 6 cm H20
| Study group | Role | What they receive |
|---|---|---|
| NHF high | Experimental | Nasal high flow therapy 8L/min Receives: Other: NHF high |
| NHF low | Experimental | Nasal high flow therapy 6L/min Receives: Other: NHF low |
| NCPAP | Active comparator | Nasal continuous positive airway pressure 6 cm H20 Receives: Other: NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Treatment failure is a composite outcome defined as meeting one of the following treatment failure criteria within 24 hours of starting of intervention:
- >2 apneas with concomitant bradycardias (<100/min) per hour for > 1 hour or
- FiO2 > 0.3 consistently for > 1 hour or
- Significant chest recessions (Silverman Score ≥ 5) for > 1 hour or
- Respiratory rate > 60/min consistently for > 1 hour or
- Any need for intermittent positive pressure ventilation
The presence of "Treatment failure" within 24 hours of starting of intervention will be documented (dichotomous outcome; yes/no).
Measured: 24 hours
Secondary outcomes (30)
Apneas and bradycardias
The total frequency of apneas and bradycardias (<100/min) within 24 hours of starting of intervention will be documented.
Measured: 24 hours
Respiratory rate (RR)
The mean RR within 24 hours of starting of intervention will be documented.
Measured: 24 hours
Heart rate (HR)
The mean HR within 24 hours of starting of intervention will be documented.
Measured: 24 hours
Oxygen saturation (SpO2) and fraction of inspired oxygen (FiO2)
The mean SpO2/FiO2 ratio within 24 hours of starting of intervention will be documented.
Measured: 24 hours
Frequency of any treatment failure
Treatment failure is a composite outcome (see "Outcome 1"). The frequency of any treatment failure during the duration of the study will be documented.
Measured: Individual study duration: estimated to be between a minimum of 7 days to an (estimated) maximum of 10 weeks.
Rescue NCPAP
Rescue NCPAP is defined as NCPAP >6 cm H2O. The frequency of need for Rescue NCPAP during the duration of the study will be collected.
Measured: Individual study duration: estimated to be between 7 days to 10 weeks.
Postmenstrual age (PMA) off positive pressure support
The investigators will document the PMA when the infant is off positive pressure support.
Measured: Estimated to be at a PMA of approximately 29 to 34 weeks.
Postmenstrual age (PMA) off FiO2 > 0.21
The investigators will document the PMA when the infant is off FiO2 > 0.21
Measured: Estimated to be at a PMA between approximately 28 to 34 weeks.
Postmenstrual age (PMA) at discharge
The investigators will document the PMA when the infant is being discharged from the hospital.
Measured: Estimated to be at a PMA of approximately 38-40 weeks.
Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after start of the intervention
The cerebral oxygen saturation (cRSO2) in [%] 1 hour before until 3 hours after start of the intervention will be measured by using Near-infrared spectroscopy (NIRS).
Measured: 4 hours
Time spent <55% cRSO2 1 hour before until 3 hours after start of the intervention
The time spent <55% cRSO2 in [min] 1 hour before until 3 hours after start of the intervention will be measured by using Near-infrared spectroscopy (NIRS).
Measured: 4 hours
Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after cessation of the intervention
The cerebral oxygen saturation (cRSO2) in [%] 1 hour before until 3 hours after cessation of the intervention will be measured by using Near-infrared spectroscopy (NIRS).
Measured: 4 hours
Time spent <55% cRSO2 1 hour before until 3 hours after cessation of the intervention
The time spent <55% cRSO2 in [min] 1 hour before until 3 hours after cessation of the intervention will be measured by using Near-infrared spectroscopy (NIRS).
Measured: 4 hours
Change in end-expiratory lung impedance (ΔEELI)
The change Δ in end-expiratory lung impedance (ΔEELI) will be measured using electrical impedance tomography (EIT) at 9 different timepoints during the first 48 hours after starting of intervention. One measurement will last 6 minutes.
The measurements will take place:
- within 30 minutes before starting of intervention (baseline measurement)
- 3 minutes before until 3 minutes after starting of intervention
- within 30 minutes after starting of intervention
- 2, 6, 12, 24, 36, and 48 hours after starting of intervention
Measured: 48 hours
Change in global inhomogeneity (ΔGI) index
The change Δ in global inhomogeneity (ΔGI) index will be measured using electrical impedance tomography (EIT) at 9 different timepoints during the first 48 hours after starting of intervention. One measurement will last 6 minutes.
The measurements will take place:
- within 30 minutes before starting of intervention (baseline measurement)
- 3 minutes before until 3 minutes after starting of intervention
- within 30 minutes after starting of intervention
- 2, 6, 12, 24, 36, and 48 hours after starting of intervention
Measured: 48 hours
Change in variability of tidal volume (ΔTV)
The change Δ in variability of tidal volume (ΔTV) will be measured using electrical impedance tomography (EIT) at 9 different timepoints during the first 48 hours after starting of intervention. One measurement will last 6 minutes.
The measurements will take place:
- within 30 minutes before starting of intervention (baseline measurement)
- 3 minutes before until 3 minutes after starting of intervention
- within 30 minutes after starting of intervention
- 2, 6, 12, 24, 36, and 48 hours after starting of intervention
Measured: 48 hours
Change in ratio of tidal volume anterior/posterior (ΔRatio TV ap)
The change Δ in ratio of tidal volume anterior/posterior (ΔRatio TV ap) will be measured using electrical impedance tomography (EIT) at 9 different timepoints during the first 48 hours after starting of intervention. One measurement will last 6 minutes.
The measurements will take place:
- within 30 minutes before starting of intervention (baseline measurement)
- 3 minutes before until 3 minutes after starting of intervention
- within 30 minutes after starting of intervention
- 2, 6, 12, 24, 36, and 48 hours after starting of intervention
Measured: 48 hours
Incidence of Bronchopulmonary dysplasia (BPD)
The incidence with specification of severity of BPD at 36 weeks PMA will be documented. BPD is a form of chronic lung disease (CLD).
BPD is classified into 3 levels of severity according to the internationally used definition of Jobe and Bancalari (1).
FiO2 >0.21 for ≥ 28 days and
- Breathing room air (mild)
- FiO2 <0.3 (moderate)
- FiO2 ≥ 0.3 and/or positive pressure support (severe) (1) Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001;163(7):1723-9.
Measured: At 36 weeks PMA
Urinary cortisol
A 24-hour-urine-sample will be collected on the third study day. The urinary production rates of cortisol and the most important metabolites will be documented as an indicator for infant stress.
Measured: 24 hours
COMFORTneo score
The COMFORTneo score will be documented on the third, fourth and fifth study day. The score measures comfort and chronic pain by observation.
Measured: 72 hours
Revised Bernese Pain Scale for Neonates (BSN-R) score
The BSN-R score will be documented on the third, fourth and fifth study day. The score measures pain.
Measured: 72 hours
Parental assessment of comfort
The parents will be asked 3 predefined questions concerning their infants' comfort on the on the third, fourth and fifth study day.
Measured: 72 hours
NASA Task Load Index (NASA-TLX)
The NASA-TLX will be filled out by the participants' nurses on the third, fourth and fifth study day. The NASA-TLX is a questionnaire that measures workload.
Measured: 72 hours
Nasal trauma score
The nasal trauma score is assessed according to internal standard guidelines in case of a present nasal trauma. The highest respective score and time of assessment will be documented on the participant CRF at 36 weeks PMA. Measuring nasal trauma using the Nasal trauma score takes approximately 20 seconds.
Measured: Individual study duration: estimated to be between 7 days to 10 weeks.
Behavioral Sleep stage classification for Preterm Infants (BeSSPI)
Sleep-wake cycles as determined by the BeSSPI on the fourth study day will be documented. The BeSSPI identifies sleep stages by observation and takes approximately 2.5 hours.
Measured: 24 hours
Parental Bonding Questionnaire (PBQ)
The score of the PBQ will be documented at 36 weeks PMA. The PBQ investigates infant-parental bonding.
Measured: At 36 weeks PMA
Age at initiating breastfeeds
The postmenstrual age (PMA) at initiating breastfeeds will be documented. This refers to the PMA at which the first successful breastfeeding attempt takes place.
Measured: Estimated to be between 30-34 weeks PMA.
Age at reaching full breastfeeds
The postmenstrual age (PMA) at reaching full breastfeeds will be documented. This corresponds to 100% nutrition per breastfeeds for 24 consecutive hours.
Measured: Estimated to be between 34-40 weeks PMA.
Weight
The weight in [g] at 36 weeks postmenstrual age (PMA) will be documented.
Measured: At 36 weeks PMA
Head circumference
The head circumference in [cm] at 36 weeks postmenstrual age (PMA) will be documented.
Measured: At 36 weeks PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jul 2023
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Kidszun, Prof. Dr. med., Principal investigator, Division of Neonatology, Department of Pediatrics, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908227
- Sponsor's protocol ID
- 2022-02287
- Acronym
- MASTER
- Status last verified
- Feb 2025
- First submitted
- 30 May 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.
PubMed 11401896
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants (MASTER Trial)
- ClinicalTrials.gov ID
- NCT05908227
- Acronym / sponsor ID
- MASTER / 2022-02287
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Nasal high flow therapy, Continuous positive airway pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 18 Jun 2023 (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.
Premature babies often need help breathing for a longer period of time. Traditionally, this is done with a breathing aid called NCPAP (nasal continuous positive airway pressure). This treatment is safe and effective, but it is very time-consuming and can sometimes have side effects. In the present research project, the investigators want to find out whether another type of breathing aid called NHF (nasal high flow therapy) is just as effective for stable premature babies. The investigators suspect that NHF is just as effective, but easier to use and more comfortable.
Detailed description
This is a multi center parallel group three arm randomized controlled clinical trial investigating cardiorespiratory stability in stable preterm infants receiving NHF.
Currently, NCPAP remains the gold standard for administration of prolonged non-invasive ventilatory support in very preterm infants. NHF is a promising method for tailored, less invasive long-term ventilatory support for preterm infants. If ventilatory support with NHF is similarly effective to conventional NCPAP in stable preterm infants, clinicians are likely to adopt this method for widespread clinical use because of its improved comfort and potential other benefits. Primary aim of this trial is to examine cardiorespiratory stability in preterm infants treated with two commonly used NHF flowrates (Interventional group 1 and 2) in comparison to NCPAP (Comparator). Secondary aim is to examine potential comfort-related beneficial effects of NHF.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NHF high | Experimental | Other: NHF highNasal high flow therapy 8L/min |
| NHF low | Experimental | Other: NHF lowNasal high flow therapy 6L/min |
| NCPAP | Active comparator | Other: NCPAPNasal continuous positive airway pressure 6 cm H20 |
Who may qualify
- Ages
- 23 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Preterm infants up to 31+6 weeks GA admitted to the Division of Neonatology at Inselspital Bern, Switzerland or Division of Neonatology at the University Medical Center of the Johannes Gutenberg-University Mainz, Germany (inborn or outborn)
- >2nd day of life (defined as date day)
- Stable on NCPAP 6 cm H2O for ≥ 24 hours, defined as:
- Parents with an age 18+ years
- Written parental informed consent (or other legal representative)
Key exclusion criteria (3 listed)
- Significant fetal anomalies
- Primary palliative care
- Stable on NCPAP 6 cm H2O according to stability criteria for more than 120 hours
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 |
|---|---|---|
| NHF highNasal high flow therapy 8L/min. | Other | NHF high |
| NHF lowNasal high flow therapy 6L/min. | Other | NHF low |
| NCPAPNasal continuous positive airway pressure 6 cm H20 | Other | NCPAP |
Primary outcome
Treatment failure
Time frame: 24 hours
Treatment failure is a composite outcome defined as meeting one of the following treatment failure criteria within 24 hours of starting of intervention: 1. >2 apneas with concomitant bradycardias (<100/min) per hour for > 1 hour or 2. FiO2 > 0.3 consistently for > 1 hour or 3. Significant chest recessions (Silverman Score ≥ 5) for > 1 hour or 4. Respiratory rate > 60/min consistently for > 1 hour or 5. Any need for intermittent positive pressure ventilation The presence of "Treatment failure" within 24 hours of starting of intervention will be documented (dichotomous outcome; yes/no).
30 secondary outcomes
Apneas and bradycardias
Time frame: 24 hours
Respiratory rate (RR)
Time frame: 24 hours
Heart rate (HR)
Time frame: 24 hours
Oxygen saturation (SpO2) and fraction of inspired oxygen (FiO2)
Time frame: 24 hours
Frequency of any treatment failure
Time frame: Individual study duration: estimated to be between a minimum of 7 days to an (estimated) maximum of 10 weeks.
Rescue NCPAP
Time frame: Individual study duration: estimated to be between 7 days to 10 weeks.
Postmenstrual age (PMA) off positive pressure support
Time frame: Estimated to be at a PMA of approximately 29 to 34 weeks.
Postmenstrual age (PMA) off FiO2 > 0.21
Time frame: Estimated to be at a PMA between approximately 28 to 34 weeks.
Postmenstrual age (PMA) at discharge
Time frame: Estimated to be at a PMA of approximately 38-40 weeks.
Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after start of the intervention
Time frame: 4 hours
Time spent <55% cRSO2 1 hour before until 3 hours after start of the intervention
Time frame: 4 hours
Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after cessation of the intervention
Time frame: 4 hours
Time spent <55% cRSO2 1 hour before until 3 hours after cessation of the intervention
Time frame: 4 hours
Change in end-expiratory lung impedance (ΔEELI)
Time frame: 48 hours
Change in global inhomogeneity (ΔGI) index
Time frame: 48 hours
Change in variability of tidal volume (ΔTV)
Time frame: 48 hours
Change in ratio of tidal volume anterior/posterior (ΔRatio TV ap)
Time frame: 48 hours
Incidence of Bronchopulmonary dysplasia (BPD)
Time frame: At 36 weeks PMA
Urinary cortisol
Time frame: 24 hours
COMFORTneo score
Time frame: 72 hours
Revised Bernese Pain Scale for Neonates (BSN-R) score
Time frame: 72 hours
Parental assessment of comfort
Time frame: 72 hours
NASA Task Load Index (NASA-TLX)
Time frame: 72 hours
Nasal trauma score
Time frame: Individual study duration: estimated to be between 7 days to 10 weeks.
Behavioral Sleep stage classification for Preterm Infants (BeSSPI)
Time frame: 24 hours
Parental Bonding Questionnaire (PBQ)
Time frame: At 36 weeks PMA
Age at initiating breastfeeds
Time frame: Estimated to be between 30-34 weeks PMA.
Age at reaching full breastfeeds
Time frame: Estimated to be between 34-40 weeks PMA.
Weight
Time frame: At 36 weeks PMA
Head circumference
Time frame: At 36 weeks PMA
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 21 Feb 2025.
- Results publication: PubMed 11401896Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.
- Individual participant dataSharing planned: No
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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.
André Kidszun, Prof. Dr. med. principal investigator
Division of Neonatology, Department of Pediatrics, Inselspital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NHF high, NHF low and NCPAP in people with Respiratory Distress Syndrome, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.
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 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. 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 Lisa Marie Bünte (+41 31 632 19 23, lisamarie.buente@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 24 hours). 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 NCT05908227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.