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RecruitingNCT07550218Updated Aug 20, 2026

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

An observational study in Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Respiratory Distress Syndrome (Neonatal) and Respiratory Distress Syndrome (RDS), sponsored by Vastra Gotaland Region. Recruiting at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2026-08-20.

Primary conditionHyaline Membrane DiseaseRegistry: Respiratory Distress SyndromeReclassifiedWhy we changed it
Registry
Respiratory Distress Syndrome — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hyaline Membrane Disease
Why
  1. The study's listed conditions name Hyaline Membrane Disease, a narrower term within Respiratory Distress Syndrome.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Vastra Gotaland Region · Observational

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Sex
All
01

Study 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 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.

02

Conditions studied

  • Respiratory Distress Syndrome (& [Hyaline Membrane Disease])
  • Respiratory Distress Syndrome (Neonatal)
  • Respiratory Distress Syndrome (RDS)
  • Respiratory Distress Syndrome of Newborn
  • Respiratory Distress Syndrome in Premature Infant

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
03

In context

Hyaline Membrane Disease Reclassified

25 studies on the registry are indexed under Hyaline Membrane Disease; 10 are open to participants now.

Browse Hyaline Membrane Disease studies →

Lead sponsor

Vastra Gotaland Region is the lead sponsor of 275 studies on the registry; 109 are open to participants now.

Browse Vastra Gotaland Region studies →

Compared within Hyaline Membrane Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Respiratory Distress Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Not fulfilling above inclusion criteria
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
6 Years
Patient registry
Yes

Groups and cohorts

  • SALSA

    Surfactant Administration via Laryngeal or Supraglottic Airway

  • LISA

    Less Invasive Surfactant Administration using a thin catheter applied below the vocal cords guided by laryngoscopy

  • INSURE

    Intubation-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 ventilatio

    Continued on mechanical ventilation \>1 hour

06

What researchers measure

Primary outcomes

  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.

    Time frame: Within 72 hours after first surfactant treatment

Secondary outcomes

  1. Bradycardia <100 bpm (any duration)

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

  5. Duration of bradycardia <100 and <60 bpm

    Continous variable. Measured by pulse oximetry.

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

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

    Continuous variable (seconds). Measured by pulse oximetry.

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

  7. Surfactant-like content in gastric aspirate

    Continous variable, ml.

    Time frame: 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.

    Time frame: Directly after first surfactant administration

  9. Surfactant reflux

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

    Time frame: Directly after first surfactant administration

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

    Continuous variable.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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

    Time frame: Within 72 hours after first surfactant administration

  15. Documented reason for mechanical ventilation

    Categorical (Nominal).

    Time frame: Within 72 hours after first surfactant administration

  16. Documented reason for repeat surfactant

    Categorical (nominal).

    Time frame: Within 72 hours after first surfactant administration

  17. FiO2 requirement at time of intubation

    Numerical variable.

    Time frame: 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.

    Time frame: Before discharge (about 2-20 weeks)

  19. Total cumulative days of CPAP/NIPPV

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

    Time frame: Before discharge (about 2-20 weeks)

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

    Numerical variable (days).

    Time frame: Before discharge (about 2-20 weeks)

  21. Total cumulative days of nasal high flow cannula

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

    Time frame: 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.

    Time frame: Before discharge (about 2-20 weeks)

  23. FiO2 requirement before repeat surfactant

    Numerical variable.

    Time frame: Within 72 hours after first surfactant administration

  24. Time to repeat surfactant

    Numerical variable.

    Time frame: Before discharge (about 2-20 weeks)

  25. Time to mechanical ventilation

    Numerical variable.

    Time frame: Before discharge (about 2-20 weeks)

  26. Total cumulative days of mechanical ventilation, conventional

    Numerical variable.

    Time frame: Before discharge (about 2-20 weeks)

  27. Total cumulative days of supplemental O2

    Numerical variable.

    Time frame: Before discharge (about 2-20 weeks)

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

    Age, date and duration.

    Time frame: Before discharge (about 2-20 weeks)

  29. Death

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  30. Time to death

    Numerical variable.

    Time frame: Before discharge (about 2-20 weeks)

  31. Cause of death

    Categorical (Nominal).

    Time frame: Before discharge (about 2-20 weeks)

  32. Intraventricular heamorrhage (IVH)

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  33. Highest grade of IVH, any side

    Categorical (ordinal)

    Time frame: Before discharge (about 2-20 weeks)

  34. Post-haemorrhagic ventricular dilatation (PHVD)

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  35. Cystic periventricular leukomalacia (cPVL)

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  36. Bronchopulmonary dysplasia (BPD)

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  37. Severe BPD

    Categorical (Yes/No).

    Time frame: Before discharge (about 2-20 weeks)

  38. Pneumothorax

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  39. Thoracic drain

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  40. Early Onset Sepsis, culture verified

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  41. Early Onset Sepsis, clinical diagnosis

    Categorical (Yes/No).

    Time frame: Before discharge (about 2-20 weeks)

  42. Late Onset Sepsis, culture verified

    Categorical (Yes/No).

    Time frame: Before discharge (about 2-20 weeks)

  43. Late Onset Sepsis, clinical diagnosis

    Categorical (Yes/No).

    Time frame: Before discharge (about 2-20 weeks)

  44. Necrotizing Enterocolitis (NEC)

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  45. NEC with perforation

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  46. NEC with surgical treatment

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  47. Spontaneous intestinal perforation

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  48. Persistent ductus arteriosus (PDA), medical treatment

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  49. PDA requiring, surgical treatment

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  50. Examined for retinopathy of prematurity (ROP)

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  51. Maximim ROP any side, grade

    Categorical (ordinal).

    Time frame: Before discharge (about 2-20 weeks)

  52. ROP ≥ grade 3

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  53. ROP treatment

    Categorical (Yes/No)

    Time frame: Before discharge (about 2-20 weeks)

  54. Major neonatal morbidity

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

    Time frame: Before discharge (about 2-20 weeks)

  55. Weight at discharge

    Numerical variable. Grams.

    Time frame: Before discharge (about 2-20 weeks)

  56. Δ-weight at discharge

    Numerical variable. Grams.

    Time frame: Before discharge (about 2-20 weeks)

  57. Supplemental oxygen at discharge from hospital

    Categorical variable (Yes/No).

    Time frame: Before discharge (about 2-20 weeks)

  58. Duration of admission (in-patient care)

    Numerical variable. Days.

    Time frame: Before discharge (about 2-20 weeks)

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

    Categorical (nominal).

    Time frame: Follow-up at 2 years of age

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

    Categorical (nominal).

    Time frame: Follow-up at 2 years of age

  61. Speech and language development

    Categorical (ordinal)

    Time frame: Follow-up at 2 years of age

  62. Visual impairment

    Categorical (Yes/No)

    Time frame: Follow-up at 2 years of age

  63. Visual impairment, left; right

    Categorical (ordinal).

    Time frame: Follow-up at 2 years of age

  64. Hearing impairment

    Categorical (Yes/no)

    Time frame: Follow-up at 2 years of age

  65. Hearing impairment, left; right

    Categorical (ordinal)

    Time frame: Follow-up at 2 years of age

  66. Bayley score (all scores for all categories)

    Numerical variable.

    Time frame: Follow-up at 2 years of age

  67. Assessed as normal development at follow-up

    Categorical (Yes/No).

    Time frame: Follow-up at 2 years of age

  68. Assessed as not normal in following area

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

    Time frame: Follow-up at 2 years of age

  69. Seizure disorder

    Categorical (ordinal)

    Time frame: Follow-up at 2 years of age

  70. Hydrocephalus

    Categorical (categorical)

    Time frame: Follow-up at 2 years of age

  71. Cerebral paresis

    Categorical (Yes/No).

    Time frame: Follow-up at 2 years of age

  72. Gross motor function scale

    Categorical (ordinal).

    Time frame: Follow-up at 2 years of age

  73. Any new diagnoses after discharge

    ICD- 10-codes.

    Time frame: Follow-up at 2 years of age

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

    Categorical (nominal).

    Time frame: Follow-up at 5,5 years of age

  75. Treatment for above during the past 12 months

    Categorical (ordinal)

    Time frame: Follow-up at 5,5 years of age

  76. Visual impairment

    Categorical (Yes/No).

    Time frame: Follow-up at 5,5 years of age

  77. Visual impairment, left

    Categorical (ordinal).

    Time frame: Follow-up at 5,5 years of age

  78. Visual impairment, right

    Categorical (ordinal).

    Time frame: Follow-up at 5,5 years of age

  79. Hearing impairment

    Categorical (Yes/No)

    Time frame: Follow-up at 5,5 years of age

  80. Hearing impairment, left

    Categorical (ordinal)

    Time frame: Follow-up at 5,5 years of age

  81. Hearing impairment, right

    Categorical (ordinal)

    Time frame: Follow-up at 5,5 years of age

  82. Speech and language development

    Categorical (ordinal)

    Time frame: Follow-up at 5,5 years of age

  83. Seizure disorder

    Categorical (ordinal)

    Time frame: Follow-up at 5,5 years of age

  84. Hydrocephalus

    Categorical (ordinal)

    Time frame: Follow-up at 5,5 years of age

  85. Cerebral paresis

    Categorical (Yes/No).

    Time frame: Follow-up at 5,5 years of age

  86. Gross motor function scale

    Categorical (ordinal).

    Time frame: Follow-up at 5,5 years of age

  87. Manual abilities classification system

    Numerical variable.

    Time frame: Follow-up at 5,5 years of age

  88. WIPPSI, (all scores for all categories)

    Numerical variable.

    Time frame: Follow-up at 5,5 years of age

  89. Strengths and difficulties questionnaire (SDQ) scores

    Numerical variable.

    Time frame: Follow-up at 5,5 years of age

  90. Any new diagnoses after discharge

    ICD-10 codes

    Time frame: Follow-up at 5,5 years of age

  91. Assessed as normal development at follow-up

    Categorical (Yes/No)

    Time frame: Follow-up at 5,5 years of age

  92. Assessed as not normal in following area

    Categorical (nominal)

    Time frame: Follow-up at 5,5 years of age

Other outcomes

  1. Pain score

    Continous variable. Using neonatal pain scale. Centre specific and scale may vary.

    Time frame: Before, during and up to 1h after procedure

07

Study locations

1 of 1 sites recruiting
  • Neonatal Intensive Care Unit, Sahlgrenska University Hostal
    Gothenburg, 416 50, Sweden
    Recruiting
    • Mårten Larsson, M.D. · Contactmarten.larsson@vgregion.se · +46 31 343 41 83
    • Anders Elfvin, Professor, M.D, Ph.D · Contactanders.elfvin@vgregion.se · +46 31 343 41 83
    • Anders Elfvin, Professor, M.D, Ph.D · Principal investigator
    • Mårten Larsson, M.D. · Sub investigator
    • Anders Flisberg, M.D., Ph.D. · Sub investigator
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2026 (actual). Primary completion is estimated for May 2029, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2026
First posted
Apr 24, 2026
StartActual
May 25, 2026
Primary completionEst.
May 25, 2029
CompletionEst.
Oct 25, 2029
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07550218
Lead sponsor
Vastra Gotaland Region
Collaborators
Göteborg University
Responsible party
Sponsor
First posted
Apr 24, 2026
Start date
May 25, 2026
Primary completion
May 25, 2029 (estimated)
Completion
Oct 25, 2029 (estimated)
Last update
Aug 20, 2026

Study contacts

Anders Elfvin, Professor
Contact
anders.elfvin@vgregion.se
+46313438073
Mårten Larsson, M.D
Contact
marten.larsson@vgregion.se
+46704240972
Anders Elfvin, Professor
principal investigator · Department of Neonatology, Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Region Västra Götaland, Sweden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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