A Phase 4 interventional study of Poractant alfa (Curosurf®) - 1-minute administration and Poractant alfa (Curosurf®) - 5-minute administration in Neonates and Preterm Infants, Infant Respiratory Distress Syndrome and Surfactant Deficiency Syndrome Neonatal, sponsored by Medical University of Graz. Recruiting at 1 site in Austria. Open to participants aged 0 Months to 72 Hours. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Medical University of Graz · Phase 4, Interventional, and Treatment
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).
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.
301 studies on the registry are indexed under Pulmonary Atelectasis; 80 are open to participants now.
This study's planned enrollment of 76 is above the median of 61 across 222 interventional studies indexed under Pulmonary Atelectasis.
Browse Pulmonary Atelectasis studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
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Exclusion Criteria:
Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 1 minute.
Drug: Poractant alfa (Curosurf®) - 1-minute administration
Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 5 minutes.
Drug: Poractant alfa (Curosurf®) - 5-minute administration
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®, 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.
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.
Time frame: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Within 48 hours after first LISA procedure
Need for invasive ventilation
Proportion of infants requiring intubation and mechanical ventilation due to respiratory failure.
Time frame: 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.
Time frame: At 36 weeks corrected gestational age
Intraventricular haemorrhage (IVH)
Incidence of any IVH assessed by cranial ultrasound
Time frame: At 40 weeks of corrected age
Periventricular leukomalacia (PVL)
Presence of cystic PVL or increased periventricular echogenicity consistent with white matter injury.
Time frame: At 40 weeks of corrected age
Retinopathy of prematurity
Presence of ROP
Time frame: At 40 weeks of corrected age
Necrotizing enterocolitis (NEC)
Presence of NEC
Time frame: At 40 weeks of corrected age
Mortality
Occurence of mortality during hospital stay
Time frame: At 40 weeks of corrected age
Plan to share: 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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