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Respiratory Distress Syndrome (& [Hyaline Membrane Disease])NCT07550218

Surfactant Administration Methods in Preterm Infants With RDS: A Swedish Cohort Study

An observational study of Respiratory Distress Syndrome (& [Hyaline Membrane Disease]) and Respiratory Distress Syndrome (Neonatal), run by Vastra Gotaland Region at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to evaluate different methods of surfactant administration in preterm infants with respiratory distress syndrome (RDS). Preterm infants often have immature lungs and a deficiency of surfactant, a substance that helps keep the lungs open and supports oxygen exchange.Surfactant… Read more about this study

Who is it for?
Any age
How many people
300 participants
Where
1 siteSweden
Study dates
25 May 2026to 25 Oct 2029
How long will I take part?
6 Years
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Newborn infants admitted to neonatal units in Västra Götaland Region, Sweden.

Who may be able to join

  • Patient has received surfactant by any administration method
  • Gestational age below 37 weeks'
  • First surfactant treatment given before 48 hours of age
  • Confirmed or suspected diagnosis of respiratory distress syndrome (RDS)

Who cannot join

  • Not fulfilling above inclusion criteria

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anders Elfvin, Professor contact

+46313438073

anders.elfvin@vgregion.se

Mårten Larsson, M.D contact

+46704240972

marten.larsson@vgregion.se

Sweden1 site, 1 recruiting

  • Neonatal Intensive Care Unit, Sahlgrenska University Hostal

    Gothenburg, 416 50

    Mårten Larsson, M.D., +46 31 343 41 83, marten.larsson@vgregion.se

    Anders Elfvin, Professor, M.D, Ph.D, +46 31 343 41 83, anders.elfvin@vgregion.se

    Recruiting

Other trials in Sweden

About this study

Official title: A Prospective Observational Study of Surfactant AdministrationMethods for Preterm Infants With Respiratory Distress SyndromeWith Long-term Follow-up in the Swedish Neonatal Quality Register

The goal of this observational study is to evaluate different methods of surfactant administration in preterm infants with respiratory distress syndrome (RDS). Preterm infants often have immature lungs and a deficiency of surfactant, a substance that helps keep the lungs open and supports oxygen exchange.Surfactant can be delivered to the lungs using different techniques, including INSURE (brief intubation), LISA (via a thin catheter), SALSA (via a laryngeal mask airway), and traditional administration via endotracheal intubation followed by mechanical ventilation. The main question this study aims to answer is:Which method of surfactant administration is associated with better clinical outcomes in preterm infants with RDS?The study will prospectively collect clinical data on infants receiving surfactant as part of standard care, with long-term follow-up using data from the Swedish Neonatal Quality Register. The results are intended to be used to inform the design of a future randomized multicenter study.

Read the detailed description

Background Complications of preterm birth are the leading cause of child mortality worldwide, with respiratory distress syndrome (RDS) as a major contributor. RDS is primarily caused by surfactant deficiency due to immature lungs. Early surfactant therapy, in combination with antenatal corticosteroids and non-invasive respiratory support such as continuous positive airway pressure (CPAP), is central to treatment. However, mechanical ventilation is associated with an increased risk of lung injury and bronchopulmonary dysplasia (BPD), prompting the development of less invasive surfactant administration techniques.

Surfactant Administration Methods Three main methods are currently used in spontaneously breathing preterm infants. The INSURE method involves transient intubation for surfactant delivery followed by extubation. Less Invasive Surfactant Administration (LISA) uses a thin catheter inserted below the vocal cords under laryngoscopy, allowing continued spontaneous breathing. LISA is recommended as first-line treatment in European guidelines due to improved outcomes compared to INSURE. However, both methods require laryngoscopy and are technically demanding, with potential adverse events.

Surfactant Administration via Laryngeal or Supraglottic Airways (SALSA) is a newer, less invasive technique that delivers surfactant via a supraglottic airway without laryngoscopy or passage through the vocal cords. Preliminary studies suggest comparable effectiveness to INSURE and CPAP, with potential safety advantages. Historically, SALSA has been limited to larger infants due to lack of appropriately sized devices, but newly available CE-marked devices now enable its use in extremely preterm infants.

Rationale Despite widespread use of INSURE, LISA, and SALSA, there are no direct comparisons between LISA and SALSA, and real-world data on their implementation, safety, and outcomes are limited. In Sweden, these methods are used variably across neonatal units, and their relative use and outcomes have not been systematically evaluated. The availability of smaller supraglottic airway devices now allows evaluation of SALSA in the most vulnerable population, including extremely preterm infants.

Aim The primary aim is to prospectively evaluate and compare the feasibility, safety, clinical performance, and procedural characteristics of surfactant administration methods (SALSA, LISA, INSURE) in spontaneously breathing preterm infants in a real-world clinical setting.

Secondary aims include comparison with infants receiving surfactant via intubation followed by mechanical ventilation, evaluation of short- and long-term clinical outcomes, and generation of data to inform the design of a future randomized multicentre trial.

Study Design This is a prospective, multicentre, observational study conducted in neonatal intensive care units (NICUs) in Region Västra Götaland (VGR), Sweden. No interventions are introduced, and all treatment decisions are made according to local clinical guidelines.

Study Population Eligible participants are preterm infants (37 weeks' gestation) receiving their first surfactant treatment within 48 hours of birth due to suspected or confirmed RDS. Infants are included regardless of administration method.

Data Collection and Follow-up Data are collected from routine clinical documentation, structured procedure forms, clinician surveys, and the Swedish Neonatal Quality Register (SNQ). Variables include perinatal factors, procedural details, respiratory outcomes, and morbidity. Infants are followed until discharge and, where applicable, at 2 and 5.5 years of age using SNQ data.

Outcomes The primary outcome is treatment failure, defined as the need for mechanical ventilation or repeat surfactant administration within 72 hours. Secondary outcomes include changes in oxygenation, need for respiratory support, adverse events, procedural characteristics, and short- and long-term morbidity and mortality. Clinician-reported feasibility and ease of use are also assessed.

Statistical Considerations All eligible infants will be included over a three-year period, with an expected sample size of approximately 300 infants. Analyses will include descriptive statistics, unadjusted comparisons, and multivariable regression models, with propensity score matching to address confounding.

Ethics Ethical approval has been granted by the Swedish Ethical Review Authority. Written informed consent is obtained from caregivers for participation and for permission to collect and analyse observational data. Participation is voluntary and does not affect the infant's clinical care.

Significance This study will provide real-world evidence on the use, safety, and outcomes of different surfactant administration methods, including the implementation of SALSA in extremely preterm infants. The results will inform clinical practice and provide essential data for the design of a future large-scale randomized multicentre trial.

Keywords
Preterm infants, Premature infants, Surfactant therapy, Supraglottic Airway, Laryngeal Mask Airway, Intubation, LISA, INSURE, Less Invasive Surfactant Therapy, SALSA, Surfactant via Laryngeal or Supraglottic Airway, RDS, Respiratory Distress Syndrome
Medical subject headings
Respiratory Distress Syndrome, Hyaline Membrane Disease, Pulmonary Atelectasis, Premature Birth

What participants receive

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

Study groups in NCT07550218
Study groupRoleWhat they receive
SALSASurfactant Administration via Laryngeal or Supraglottic Airway
LISALess Invasive Surfactant Administration using a thin catheter applied below the vocal cords guided by laryngoscopy
INSUREIntubation-Surfactant-Extubation. Followed by positive pressure ventilation or brief period (<1 hour) of mechanical ventilation
Group/Cohort Description: Intubation-Surfactant-Extubation. Followed by positive pressure ventilatioContinued on mechanical ventilation >1 hour

What is being measured

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

  1. Mechanical ventilation or repeat surfactant within 72 hours after first surfactant treatment delivered by LISA, SALSA or INSURE method

    Categorical variable (Yes/No). Decision to initiate mechanical ventilation via intubation will be made at the discretion of the treating physician, guided by the local NICU criteria for mechanical ventilation. Data is extracted from medical records.

    Measured: Within 72 hours after first surfactant treatment

Secondary outcomes (92)

  1. Bradycardia <100 bpm (any duration)

    Categorical variable (Yes/No). Measured by pulse oximetry and noted by team performing procedure.

    Measured: During the procedure, an average of 5-10 minutes

  2. Oesophageal/upper airway injury

    Categorical (Yes/No). Observations of infant during and post-procedure. Details provided if present.

    Measured: During and within an hour from procedure.

  3. Bradycardia <60 bpm (any duration)

    Categorical variable (Yes/No). Measured by pulse oximetry and noted by team performing procedure.

    Measured: During the procedure, an average of 5-10 minutes

  4. Desaturation to SpO₂ <80% lasting ≥30 seconds (single episode)

    Categorical variable (Yes/No). Measured by pulse oximetry and noted by team performing procedure.

    Measured: During the procedure, an average of 5-10 minutes

  5. Duration of bradycardia <100 and <60 bpm

    Continous variable. Measured by pulse oximetry.

    Measured: During the procedure, an average of 5-10 minutes

  6. Duration of desaturation <80%, <60% and <40%

    Continuous variable (seconds). Measured by pulse oximetry.

    Measured: During the procedure, an average of 5-10 minutes

  7. Surfactant-like content in gastric aspirate

    Continous variable, ml.

    Measured: Directly after first surfactant administration

  8. Proportion of administered surfactant recovered in gastric aspirate

    Continuous variable (%). Fraction (calculated from residual aspirated surfactant and total dose (mL). Observed by clinical team during procedure and noted in CRF.

    Measured: Directly after first surfactant administration

  9. Surfactant reflux

    Categorical variable (Yes/No). Clinical reflux of surfactant during procedure.

    Measured: Directly after first surfactant administration

  10. Δ-FiO₂: Hourly change in FiO₂ from pre-procedure to 12 hours post-procedure

    Continuous variable.

    Measured: Within 15 minutes before the procedure to 12 hours after first surfactant administration

  11. Δ-SpO2/FiO2-ratio: Change in SpO₂/FiO₂ ratio from pre-procedure to 4 hours post-procedure

    Continuous variable.

    Measured: Within 15 minutes before the procedure to 4 hours after first surfactant administration

  12. Early failure: Mechanical ventilation within 1 hour of first surfactant administration

    Categorical variable (Yes/no).

    Measured: Within 1 hour after first surfactant administration

  13. Mechanical ventilation within 72 hours of first surfactant administration

    Categorical variable (Yes/No). Decision to initiate mechanical ventilation via intubation will be made at the discretion of the treating physician, guided by the local NICU criteria for mechanical ventilation. Data is extracted from medical records.

    Measured: Within 72 hours after first surfactant administration

  14. Repeat surfactant within 72 hours of first surfactant administration

    Categorical variable (Yes/No). Decision to repeat surfactant will be made at the discretion of the treating physician, guided by the local NICU guideline. Data is extracted from medical records. When

    Measured: Within 72 hours after first surfactant administration

  15. Documented reason for mechanical ventilation

    Categorical (Nominal).

    Measured: Within 72 hours after first surfactant administration

  16. Documented reason for repeat surfactant

    Categorical (nominal).

    Measured: Within 72 hours after first surfactant administration

  17. FiO2 requirement at time of intubation

    Numerical variable.

    Measured: Within 72 hours after first surfactant administration

  18. Mechanical ventilation at any time during admission and duration

    Categorical variable (Yes/No). Decision to initiate mechanical ventilation via intubation will be made at the discretion of the treating physician, guided by the local NICU criteria for mechanical ventilation.

    Measured: Before discharge (about 2-20 weeks)

  19. Total cumulative days of CPAP/NIPPV

    Numerical variable (days). Data is collected from medical record.

    Measured: Before discharge (about 2-20 weeks)

  20. Total cumulative days of mechanical ventilation (any mode)

    Numerical variable (days).

    Measured: Before discharge (about 2-20 weeks)

  21. Total cumulative days of nasal high flow cannula

    Numerical variable (days). Data is collected from medical record.

    Measured: Before discharge (about 2-20 weeks)

  22. Total cumulative days of any respiratory support (MV, CPAP/NIPPV, HNFC, or oxygen cannula)

    Numerical variable (days). Data is collected from medical record.

    Measured: Before discharge (about 2-20 weeks)

  23. FiO2 requirement before repeat surfactant

    Numerical variable.

    Measured: Within 72 hours after first surfactant administration

  24. Time to repeat surfactant

    Numerical variable.

    Measured: Before discharge (about 2-20 weeks)

  25. Time to mechanical ventilation

    Numerical variable.

    Measured: Before discharge (about 2-20 weeks)

  26. Total cumulative days of mechanical ventilation, conventional

    Numerical variable.

    Measured: Before discharge (about 2-20 weeks)

  27. Total cumulative days of supplemental O2

    Numerical variable.

    Measured: Before discharge (about 2-20 weeks)

  28. Systemic (oral or intravenous) steroid treatment due to lung disease

    Age, date and duration.

    Measured: Before discharge (about 2-20 weeks)

  29. Death

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  30. Time to death

    Numerical variable.

    Measured: Before discharge (about 2-20 weeks)

  31. Cause of death

    Categorical (Nominal).

    Measured: Before discharge (about 2-20 weeks)

  32. Intraventricular heamorrhage (IVH)

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  33. Highest grade of IVH, any side

    Categorical (ordinal)

    Measured: Before discharge (about 2-20 weeks)

  34. Post-haemorrhagic ventricular dilatation (PHVD)

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  35. Cystic periventricular leukomalacia (cPVL)

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  36. Bronchopulmonary dysplasia (BPD)

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  37. Severe BPD

    Categorical (Yes/No).

    Measured: Before discharge (about 2-20 weeks)

  38. Pneumothorax

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  39. Thoracic drain

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  40. Early Onset Sepsis, culture verified

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  41. Early Onset Sepsis, clinical diagnosis

    Categorical (Yes/No).

    Measured: Before discharge (about 2-20 weeks)

  42. Late Onset Sepsis, culture verified

    Categorical (Yes/No).

    Measured: Before discharge (about 2-20 weeks)

  43. Late Onset Sepsis, clinical diagnosis

    Categorical (Yes/No).

    Measured: Before discharge (about 2-20 weeks)

  44. Necrotizing Enterocolitis (NEC)

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  45. NEC with perforation

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  46. NEC with surgical treatment

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  47. Spontaneous intestinal perforation

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  48. Persistent ductus arteriosus (PDA), medical treatment

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  49. PDA requiring, surgical treatment

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  50. Examined for retinopathy of prematurity (ROP)

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  51. Maximim ROP any side, grade

    Categorical (ordinal).

    Measured: Before discharge (about 2-20 weeks)

  52. ROP ≥ grade 3

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  53. ROP treatment

    Categorical (Yes/No)

    Measured: Before discharge (about 2-20 weeks)

  54. Major neonatal morbidity

    Categorical (Yes/No). BPD, IVH ≥3, cPVL, ROP ≥ 3, or NEC with perforation.

    Measured: Before discharge (about 2-20 weeks)

  55. Weight at discharge

    Numerical variable. Grams.

    Measured: Before discharge (about 2-20 weeks)

  56. Δ-weight at discharge

    Numerical variable. Grams.

    Measured: Before discharge (about 2-20 weeks)

  57. Supplemental oxygen at discharge from hospital

    Categorical variable (Yes/No).

    Measured: Before discharge (about 2-20 weeks)

  58. Duration of admission (in-patient care)

    Numerical variable. Days.

    Measured: Before discharge (about 2-20 weeks)

  59. Asthma or obstructive respiratory symptoms during the past 12 months

    Categorical (nominal).

    Measured: Follow-up at 2 years of age

  60. Treatment for above obstructive symptoms during the past 12 months

    Categorical (nominal).

    Measured: Follow-up at 2 years of age

  61. Speech and language development

    Categorical (ordinal)

    Measured: Follow-up at 2 years of age

  62. Visual impairment

    Categorical (Yes/No)

    Measured: Follow-up at 2 years of age

  63. Visual impairment, left; right

    Categorical (ordinal).

    Measured: Follow-up at 2 years of age

  64. Hearing impairment

    Categorical (Yes/no)

    Measured: Follow-up at 2 years of age

  65. Hearing impairment, left; right

    Categorical (ordinal)

    Measured: Follow-up at 2 years of age

  66. Bayley score (all scores for all categories)

    Numerical variable.

    Measured: Follow-up at 2 years of age

  67. Assessed as normal development at follow-up

    Categorical (Yes/No).

    Measured: Follow-up at 2 years of age

  68. Assessed as not normal in following area

    Catetorical (nominal). Motor deficiency; Cognition, communication; Visual; Hearing

    Measured: Follow-up at 2 years of age

  69. Seizure disorder

    Categorical (ordinal)

    Measured: Follow-up at 2 years of age

  70. Hydrocephalus

    Categorical (categorical)

    Measured: Follow-up at 2 years of age

  71. Cerebral paresis

    Categorical (Yes/No).

    Measured: Follow-up at 2 years of age

  72. Gross motor function scale

    Categorical (ordinal).

    Measured: Follow-up at 2 years of age

  73. Any new diagnoses after discharge

    ICD- 10-codes.

    Measured: Follow-up at 2 years of age

  74. Asthma or obstructive respiratory symptoms during the past 12 months

    Categorical (nominal).

    Measured: Follow-up at 5,5 years of age

  75. Treatment for above during the past 12 months

    Categorical (ordinal)

    Measured: Follow-up at 5,5 years of age

  76. Visual impairment

    Categorical (Yes/No).

    Measured: Follow-up at 5,5 years of age

  77. Visual impairment, left

    Categorical (ordinal).

    Measured: Follow-up at 5,5 years of age

  78. Visual impairment, right

    Categorical (ordinal).

    Measured: Follow-up at 5,5 years of age

  79. Hearing impairment

    Categorical (Yes/No)

    Measured: Follow-up at 5,5 years of age

  80. Hearing impairment, left

    Categorical (ordinal)

    Measured: Follow-up at 5,5 years of age

  81. Hearing impairment, right

    Categorical (ordinal)

    Measured: Follow-up at 5,5 years of age

  82. Speech and language development

    Categorical (ordinal)

    Measured: Follow-up at 5,5 years of age

  83. Seizure disorder

    Categorical (ordinal)

    Measured: Follow-up at 5,5 years of age

  84. Hydrocephalus

    Categorical (ordinal)

    Measured: Follow-up at 5,5 years of age

  85. Cerebral paresis

    Categorical (Yes/No).

    Measured: Follow-up at 5,5 years of age

  86. Gross motor function scale

    Categorical (ordinal).

    Measured: Follow-up at 5,5 years of age

  87. Manual abilities classification system

    Numerical variable.

    Measured: Follow-up at 5,5 years of age

  88. WIPPSI, (all scores for all categories)

    Numerical variable.

    Measured: Follow-up at 5,5 years of age

  89. Strengths and difficulties questionnaire (SDQ) scores

    Numerical variable.

    Measured: Follow-up at 5,5 years of age

  90. Any new diagnoses after discharge

    ICD-10 codes

    Measured: Follow-up at 5,5 years of age

  91. Assessed as normal development at follow-up

    Categorical (Yes/No)

    Measured: Follow-up at 5,5 years of age

  92. Assessed as not normal in following area

    Categorical (nominal)

    Measured: Follow-up at 5,5 years of age

Timeline

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

  1. First posted24 Apr 2026
  2. Study start25 May 2026
  3. Primary completion25 May 2029 (estimated)
  4. Study completion25 Oct 2029 (estimated)

Resources

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
Prospective
Enrolment
300 participants (estimated)
Target duration
6 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07550218
Sponsor's protocol ID
DNR 2026-00189-01
Status last verified
May 2026
First submitted
17 Apr 2026
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant data may be made available upon reasonable request to the principal investigator. Data will be shared in a de-identified form to the greatest extent possible, following review and approval to ensure compliance with informed consent provisions, ethics committee approval, and applicable legal and data protection requirements.

Publications

  • Abdel-Latif ME, Davis PG, Wheeler KI, De Paoli AG, Dargaville PA. Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2021 May 10;5(5):CD011672. doi: 10.1002/14651858.CD011672.pub2.

    PubMed 33970483

  • Abdel-Latif ME, Walker E, Osborn DA. Laryngeal mask airway surfactant administration for prevention of morbidity and mortality in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2024 Jan 25;1(1):CD008309. doi: 10.1002/14651858.CD008309.pub3.

    PubMed 38270182

  • Sweet DG, Carnielli VP, Greisen G, Hallman M, Klebermass-Schrehof K, Lavizzari A, Ozek E, Te Pas A, Roehr CC, Saugstad OD, Simeoni U, Vento M, Visser GHA, Speer CP. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2025. Neonatology. 2026 Mar 9:1-26. doi: 10.1159/000551062. Online ahead of print.

    PubMed 41802129

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Distress Syndrome (& [Hyaline Membrane Disease]) and Respiratory Distress Syndrome (Neonatal), run by Vastra Gotaland Region at 1 site in Sweden.

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 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: looking for participants now, as of the sponsor's last update on 20 Aug 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 Sweden. 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 Anders Elfvin, Professor (+46313438073, anders.elfvin@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mechanical ventilation or repeat surfactant within 72 hours after first surfactant treatment delivered by LISA, SALSA or INSURE method (time frame: Within 72 hours after first surfactant treatment). 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 NCT07550218, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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