Neonates and Preterm InfantsPhase 4SurfStab INCT07261787
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
A Phase 4 study testing Poractant alfa (Curosurf®) - 1-minute administration and Poractant alfa (Curosurf®) - 5-minute administration in people with Neonates and Preterm Infants and Infant Respiratory Distress Syndrome, run by Medical University of Graz at 1 site in Austria.
Trial summary
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA) technique. Read more about this study
- Who is it for?
- Ages 0 months to 72 hours
- Conditions the study is for
- Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal
- What is being tested?
- Poractant alfa (Curosurf®) - 1-minute administration and Poractant alfa (Curosurf®) - 5-minute administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteAustria
- Study dates
- 20 Feb 2026to 1 Dec 2028
- Phase
- Phase 4
- 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 0 months to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonate <28+0 weeks (gestational age up to 27 weeks and 6 days)
- Indication of surfactant administration via the LISA method
- Postnatal age < 72 hours
Who cannot join
- Invasive ventilation, indication of INSURE procedure
- Severe pulmonary or cardiac malformation affecting oxygenation or congenital cerebral malformation
- Preexisiting diagnose of any IVH > grade 2 or PVH.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christina H. Wolfsberger, Priv.Doz. DDr. contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz, Division of Neonatology, Department of Pediatrics and Adolescent Medicine
Graz, 8036
About this study
Official title: Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minute Versus 5 Minutes - a Prospective Randomised-controlled Phase IV Trial - A Randomised Clinical Trial on Influence of Duration of Surfactant Administration on Stabilisation of Routine Monitoring Parameters and Cerebral Tissue Oxygen Saturation Monitoring in Preterm Neonates < 28 Weeks of Gestational Age
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA) technique. However, the optimal duration of surfactant instillation during LISA has never been systematically evaluated. Rapid instillation may provoke transient hypoxia and bradycardia, while slower administration might improve physiological stability and cerebral oxygenation.
This randomised controlled trial investigates whether the duration of surfactant administration (1 minute versus 5 minutes) affects cerebral and systemic oxygen stability in extremely preterm neonates (< 28 weeks).
Read the detailed description
The SurfStab I Trial is a single-centre, randomised, controlled, phase IV trial conducted at the Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria.
Infants born before 28 weeks of gestation and requiring surfactant therapy via the LISA technique will be randomised (1:1) to receive poractant alfa administered over either 1 minute or 5 minutes. The intervention duration represents two clinically accepted timeframes within current guideline recommendations.
Cerebral oxygenation will be monitored continuously using near-infrared spectroscopy (NIRS) from 5 minutes before to 3 hours after the procedure. The primary outcome is the maximal change in cerebral regional tissue oxygen saturation (crSO₂) from baseline (=5 minutes before starting the LISA procedure [insertion of the LISA catheter]) till 15 minutes after the LISA procedure (=removal of the LISA catheter). Secondary outcomes include changes in peripheral oxygen saturation (SpO₂), heart rate (HR), mean arterial blood pressure (MABP), frequency and duration of hypoxic or bradycardic episodes, and the need for repeated surfactant administration or invasive ventilation.
The total sample size is 76 infants (38 per arm). The study will provide evidence on whether slower surfactant administration improves physiological stability and cerebral oxygenation.
- Conditions
- Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Surfactant, Cerebral Oxygenation, Cerebral Oxygen Saturation
- Being tested
- Poractant alfa (Curosurf®) - 1-minute administration, Poractant alfa (Curosurf®) - 5-minute administration
- Keywords
- surfactant, surfactant administration, LISA, less-invasive surfactant administration, preterm neonates, cerebral oxygenation, near-infrared spectroscopy
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poractant alfa (Curosurf®) - 1-minute administrationDrug
Poractant alfa (Curosurf®, Chiesi Pharmaceuticals) administered intratracheally via the Less Invasive Surfactant Administration (LISA) technique over 1 minute.
The surfactant is instilled manually through a thin catheter under direct laryngoscopy while the infant remains on continuous positive airway pressure (CPAP) and spontaneous breathing.
Pre-specified criteria for aborting the LISA procedure are prolonged bradycardia (HR < 80 bpm) and/or arterial hypoxia (SpO2 < 80%) over 60 seconds during surfactant administration starting after the instillation of the LISA catheter. Data of included participants with discontinuation will be collected and analysed.
Poractant alfa (Curosurf®) - 5-minute administrationDrug
Poractant alfa (Curosurf®, Chiesi Pharmaceuticals) administered intratracheally via the Less Invasive Surfactant Administration (LISA) technique over 5 minute.
The surfactant is instilled manually through a thin catheter under direct laryngoscopy while the infant remains on continuous positive airway pressure (CPAP) and spontaneous breathing.
Pre-specified criteria for aborting the LISA procedure are prolonged bradycardia (HR < 80 bpm) and/or arterial hypoxia (SpO2 < 80%) over 60 seconds during surfactant administration starting after the instillation of the LISA catheter. Data of included participants with discontinuation will be collected and analysed.
| Study group | Role | What they receive |
|---|---|---|
| 1-Minute Administration ("1-min"-group) | Experimental | Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 1 minute. Receives: Drug: Poractant alfa (Curosurf®) - 1-minute administration |
| 5-Minute Administration ("5-min"-group) | Experimental | Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 5 minutes. Receives: Drug: Poractant alfa (Curosurf®) - 5-minute administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral oxygenation (crSO₂) during and after LISA
The primary outcome measure will be the maximum change of crSO2 from baseline till the end of the primary window (=duration of LISA administration + 15 minutes after removal of the thin catheter). Mean values of crSO2 during the 5min before intervention started is defined as the baseline. crSO2 parameters with beginning five minute before surfactant administration till 15 minutes after extubating will be assessed every minute.
Measured: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter
Secondary outcomes (18)
Change in arterial oxygen saturation (SpO₂) during and after LISA
The secondary outcome measure will be the maximum change of SpO2 from baseline till the end of the primary window (=duration of LISA administration + 15 minutes after removal of the thin catheter). Mean values of SpO2 during the 5min before intervention started is defined as the baseline. SpO2 parameters with beginning five minute before surfactant administration till 15 minutes after extubating will be assessed every minute.
Measured: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter
Change in heart rate (HR) during and after LISA
The secondary outcome measure will be the maximum change of HR from baseline till the end of the primary window (=duration of LISA administration + 15 minutes after removal of the thin catheter). Mean values of HR during the 5min before intervention started is defined as the baseline. HR parameters with beginning five minute before surfactant administration till 15 minutes after extubating will be assessed every minute.
Measured: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter
Change in crSO2 up to three hours after LISA
The secondary outcome measures will be crSO2 up to three hours after surfactant administration defined as maximum changes/drop from starting with the beginning of the surfactant administration after insertion of the thin catheter till three hours after LISA procedure. Vital parameters will be assessed every five minutes till three hours after LISA procedure.
Measured: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Change in SpO2 up to three hours after LISA
The secondary outcome measures will be SpO2 up to three hours after surfactant administration defined as maximum changes/drop from starting with the beginning of the surfactant administration after insertion of the thin catheter till three hours after LISA procedure. Vital parameters will be assessed every five minutes till three hours after LISA procedure.
Measured: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Change in HR up to three hours after LISA
The secondary outcome measures will be HR up to three hours after surfactant administration defined as maximum changes/drop from starting with the beginning of the surfactant administration after insertion of the thin catheter till three hours after LISA procedure. Vital parameters will be assessed every five minutes till three hours after LISA procedure.
Measured: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Change in mean arterial blood pressure (MABP) up to three hours after LISA
The secondary outcome measures will be MABP up to three hours after surfactant administration defined as maximum changes/drop from starting with the beginning of the surfactant administration after insertion of the thin catheter till three hours after LISA procedure. Vital parameters will be assessed every five minutes till three hours after LISA procedure.
Measured: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Amount of bradycardia
The secondary outcome measure will be the amount of bradycardia (in minutes) up to three hours after surfactant administration
Measured: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Amount of cerebral hypoxia
The secondary outcome measure will be the amount of cerebral hypoxia (in minutes) up to three hours after surfactant administration
Measured: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Amount of systemic hypoxia
The secondary outcome measure will be the amount of systemic hypoxia (in minutes) up to three hours after surfactant administration
Measured: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Amount of supplemental oxygen
The secondary outcome measure will be the amount of supplemental oxygen up to three hours after surfactant administration
Measured: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Need for repeat surfactant administraiton
Proportion of infants requiring a second surfactant dose as per clinical indication.
Measured: Within 48 hours after first LISA procedure
Need for invasive ventilation
Proportion of infants requiring intubation and mechanical ventilation due to respiratory failure.
Measured: Within 48 hours after first LISA procedure
Bronchopulmonary dysplasia (BPD)
Incidence of BPD, defined as oxygen and/or respiratory support requirement at 36 weeks postmenstrual age.
Measured: At 36 weeks corrected gestational age
Intraventricular haemorrhage (IVH)
Incidence of any IVH assessed by cranial ultrasound
Measured: At 40 weeks of corrected age
Periventricular leukomalacia (PVL)
Presence of cystic PVL or increased periventricular echogenicity consistent with white matter injury.
Measured: At 40 weeks of corrected age
Retinopathy of prematurity
Presence of ROP
Measured: At 40 weeks of corrected age
Necrotizing enterocolitis (NEC)
Presence of NEC
Measured: At 40 weeks of corrected age
Mortality
Occurence of mortality during hospital stay
Measured: At 40 weeks of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start20 Feb 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Dec 2028 (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 Neonates and Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Wolfsberger, MD, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261787
- Sponsor's protocol ID
- SurfStab I Trial
- Other IDs
- 2025-522754-39-00, 2025
- Acronym
- SurfStab I
- Status last verified
- May 2026
- First submitted
- 14 Nov 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study population consists of extremely preterm neonates, and complete anonymisation cannot be guaranteed due to the small sample size and highly specific physiological datasets (continuous cerebral and systemic oxygenation monitoring). Sharing such detailed physiological and clinical data could potentially allow re-identification of individual participants, even after de-identification. In addition, the national ethics approval and parental consent cover data use exclusively for the present research project and associated publications, not for open data sharing. Aggregated and summarised results will, however, be made publicly available through peer-reviewed publications and trial registries upon study completion.
Publications
Wolfsberger CH, Schwaberger B, Baik-Schneditz N, Avian A, Holter M, Pichler G. Duration of surfactant administration and its impact on stabilisation of vital parameters in very preterm neonates <28 weeks of gestational age (SurfStab): 1 min versus 5 min-study protocol for a prospective randomised-controlled phase IV trial. Front Pediatr. 2026 Sep 30;14:1939771. doi: 10.3389/fped.2026.1939771. eCollection 2026.
PubMed 42877269
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minute Versus 5 Minutes - a Prospective Randomised-controlled Phase IV Trial - A Randomised Clinical Trial on Influence of Duration of Surfactant Administration on Stabilisation of Routine Monitoring Parameters and Cerebral Tissue Oxygen Saturation Monitoring in Preterm Neonates < 28 Weeks of Gestational Age
- ClinicalTrials.gov ID
- NCT07261787
- Acronym / sponsor ID
- SurfStab I / SurfStab I Trial
- Conditions
- Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Surfactant, Cerebral Oxygenation, Cerebral Oxygen Saturation
- Keywords
- surfactant, surfactant administration, LISA, less-invasive surfactant administration, preterm neonates, cerebral oxygenation, near-infrared spectroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 3 Dec 2025 (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.
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA) technique. However, the optimal duration of surfactant instillation during LISA has never been systematically evaluated. Rapid instillation may provoke transient hypoxia and bradycardia, while slower administration might improve physiological stability and cerebral oxygenation.
This randomised controlled trial investigates whether the duration of surfactant administration (1 minute versus 5 minutes) affects cerebral and systemic oxygen stability in extremely preterm neonates (< 28 weeks).
Detailed description
The SurfStab I Trial is a single-centre, randomised, controlled, phase IV trial conducted at the Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria.
Infants born before 28 weeks of gestation and requiring surfactant therapy via the LISA technique will be randomised (1:1) to receive poractant alfa administered over either 1 minute or 5 minutes. The intervention duration represents two clinically accepted timeframes within current guideline recommendations.
Cerebral oxygenation will be monitored continuously using near-infrared spectroscopy (NIRS) from 5 minutes before to 3 hours after the procedure. The primary outcome is the maximal change in cerebral regional tissue oxygen saturation (crSO₂) from baseline (=5 minutes before starting the LISA procedure [insertion of the LISA catheter]) till 15 minutes after the LISA procedure (=removal of the LISA catheter). Secondary outcomes include changes in peripheral oxygen saturation (SpO₂), heart rate (HR), mean arterial blood pressure (MABP), frequency and duration of hypoxic or bradycardic episodes, and the need for repeated surfactant administration or invasive ventilation.
The total sample size is 76 infants (38 per arm). The study will provide evidence on whether slower surfactant administration improves physiological stability and cerebral oxygenation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Minute Administration ("1-min"-group) | Experimental | Drug: Poractant alfa (Curosurf®) - 1-minute administrationInfants receive poractant alfa (Curosurf®) administered via the LISA technique over 1 minute. |
| 5-Minute Administration ("5-min"-group) | Experimental | Drug: Poractant alfa (Curosurf®) - 5-minute administrationInfants receive poractant alfa (Curosurf®) administered via the LISA technique over 5 minutes. |
Who may qualify
- Ages
- 0 months to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm neonate <28+0 weeks (gestational age up to 27 weeks and 6 days)
- Indication of surfactant administration via the LISA method
- Postnatal age < 72 hours
Key exclusion criteria (3 listed)
- Invasive ventilation, indication of INSURE procedure
- Severe pulmonary or cardiac malformation affecting oxygenation or congenital cerebral malformation
- Preexisiting diagnose of any IVH > grade 2 or PVH.
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 (Curosurf®) - 1-minute administrationPoractant alfa (Curosurf®, Chiesi Pharmaceuticals) administered intratracheally via the Less Invasive Surfactant Administration (LISA) technique over 1 minute. The surfactant is instilled manually through a thin catheter under direct laryngoscopy while the infant remains on continuous positive airway pressure (CPAP) and spontaneous breathing. Pre-specified criteria for aborting the LISA procedure are prolonged bradycardia (HR < 80 bpm) and/or arterial hypoxia (SpO2 < 80%) over 60 seconds during surfactant administration starting after the instillation of the LISA catheter. Data of included participants with discontinuation will be collected and analysed. | Drug | 1-Minute Administration ("1-min"-group) |
| Poractant alfa (Curosurf®) - 5-minute administrationPoractant alfa (Curosurf®, Chiesi Pharmaceuticals) administered intratracheally via the Less Invasive Surfactant Administration (LISA) technique over 5 minute. The surfactant is instilled manually through a thin catheter under direct laryngoscopy while the infant remains on continuous positive airway pressure (CPAP) and spontaneous breathing. Pre-specified criteria for aborting the LISA procedure are prolonged bradycardia (HR < 80 bpm) and/or arterial hypoxia (SpO2 < 80%) over 60 seconds during surfactant administration starting after the instillation of the LISA catheter. Data of included participants with discontinuation will be collected and analysed. | Drug | 5-Minute Administration ("5-min"-group) |
Primary outcome
Change in cerebral oxygenation (crSO₂) during and after LISA
Time frame: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter
The primary outcome measure will be the maximum change of crSO2 from baseline till the end of the primary window (=duration of LISA administration + 15 minutes after removal of the thin catheter). Mean values of crSO2 during the 5min before intervention started is defined as the baseline. crSO2 parameters with beginning five minute before surfactant administration till 15 minutes after extubating will be assessed every minute.
18 secondary outcomes
Change in arterial oxygen saturation (SpO₂) during and after LISA
Time frame: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter
Change in heart rate (HR) during and after LISA
Time frame: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter
Change in crSO2 up to three hours after LISA
Time frame: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Change in SpO2 up to three hours after LISA
Time frame: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Change in HR up to three hours after LISA
Time frame: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Change in mean arterial blood pressure (MABP) up to three hours after LISA
Time frame: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Amount of bradycardia
Time frame: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Amount of cerebral hypoxia
Time frame: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Amount of systemic hypoxia
Time frame: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Amount of supplemental oxygen
Time frame: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure
Need for repeat surfactant administraiton
Time frame: Within 48 hours after first LISA procedure
Need for invasive ventilation
Time frame: Within 48 hours after first LISA procedure
Bronchopulmonary dysplasia (BPD)
Time frame: At 36 weeks corrected gestational age
Intraventricular haemorrhage (IVH)
Time frame: At 40 weeks of corrected age
Periventricular leukomalacia (PVL)
Time frame: At 40 weeks of corrected age
Retinopathy of prematurity
Time frame: At 40 weeks of corrected age
Necrotizing enterocolitis (NEC)
Time frame: At 40 weeks of corrected age
Mortality
Time frame: At 40 weeks of corrected age
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 14 May 2026.
- Derived from this study: PubMed 42877269Wolfsberger CH, Schwaberger B, Baik-Schneditz N, Avian A, Holter M, Pichler G. Duration of surfactant administration and its impact on stabilisation of vital parameters in very preterm neonates <28 weeks of gestational age (SurfStab): 1 min versus 5 min-study protocol for a prospective randomised-controlled phase IV trial. Front Pediatr. 2026 Sep 30;14:1939771. doi: 10.3389/fped.2026.1939771. eCollection 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study population consists of extremely preterm neonates, and complete anonymisation cannot be guaranteed due to the small sample size and highly specific physiological datasets (continuous cerebral and systemic oxygenation monitoring). Sharing such detailed physiological and clinical data could potentially allow re-identification of individual participants, even after de-identification. In addition, the national ethics approval and parental consent cover data use exclusively for the present research project and associated publications, not for open data sharing. Aggregated and summarised results will, however, be made publicly available through peer-reviewed publications and trial registries upon study completion.
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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.
Christina H. Wolfsberger, Priv.Doz. DDr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Poractant alfa (Curosurf®) - 1-minute administration and Poractant alfa (Curosurf®) - 5-minute administration in people with Neonates and Preterm Infants and Infant Respiratory Distress Syndrome, run by Medical University of Graz at 1 site in Austria.
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 3 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 14 May 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 Austria. 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.
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?
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 Christina H. Wolfsberger, Priv.Doz. DDr. (+43 316 385 81135, christina.wolfsberger@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral oxygenation (crSO₂) during and after LISA (time frame: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter). 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 NCT07261787, 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 14 May 2026.