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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522754-39-00 | EU Trial (CTIS) Number |
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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 (crSOâ‚‚) 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 (SpOâ‚‚), 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-Minute Administration ("1-min"-group) | Experimental | Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 1 minute. |
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| 5-Minute Administration ("5-min"-group) | Experimental | Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 5 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poractant alfa (Curosurf®) - 1-minute administration | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cerebral oxygenation (crSOâ‚‚) 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. | From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Change in arterial oxygen saturation (SpOâ‚‚) 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina H. Wolfsberger, Priv.Doz. DDr. | Contact | +43 316 385 81135 | christina.wolfsberger@medunigraz.at | |
| Gerhard Pichler, Univ.Prof. PD. Dr. | Contact | +43 316 385 80520 | gerhard.pichler@medunigraz.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz, Division of Neonatology, Department of Pediatrics and Adolescent Medicine | Recruiting | Graz | 8036 | Austria |
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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| Poractant alfa (Curosurf®) - 5-minute administration | Drug | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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. | Within 48 hours after first LISA procedure |
| Need for invasive ventilation | Proportion of infants requiring intubation and mechanical ventilation due to respiratory failure. | 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. | At 36 weeks corrected gestational age |
| Intraventricular haemorrhage (IVH) | Incidence of any IVH assessed by cranial ultrasound | At 40 weeks of corrected age |
| Periventricular leukomalacia (PVL) | Presence of cystic PVL or increased periventricular echogenicity consistent with white matter injury. | At 40 weeks of corrected age |
| Retinopathy of prematurity | Presence of ROP | At 40 weeks of corrected age |
| Necrotizing enterocolitis (NEC) | Presence of NEC | At 40 weeks of corrected age |
| Mortality | Occurence of mortality during hospital stay | At 40 weeks of corrected age |
| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C068291 | poractant alfa |
| D009934 | Organization and Administration |
| ID | Term |
|---|---|
| D006298 | Health Services Administration |
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