Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes (SurfStab I)

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).

Study Overview

• Status: Recruiting
• Conditions: Surfactant Deficiency Syndrome Neonatal; Cerebral Oxygenation; Infant Respiratory Distress Syndrome; Neonates and Preterm Infants; Cerebral Oxygen Saturation; Surfactant
• Intervention / Treatment: Drug: Poractant alfa (Curosurf®) - 1-minute administration; Drug: Poractant alfa (Curosurf®) - 5-minute administration

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 Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Christina H. Wolfsberger, Priv.Doz. DDr.; Phone Number: +43 316 385 81135; Email: christina.wolfsberger@medunigraz.at
• Study Contact Backup: Name: Gerhard Pichler, Univ.Prof. PD. Dr.; Phone Number: +43 316 385 80520; Email: gerhard.pichler@medunigraz.at

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medical University of Graz, Division of Neonatology, Department of Pediatrics and Adolescent Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1-Minute Administration ("1-min"-group); Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 1 minute.	Drug: Poractant alfa (Curosurf®) - 1-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.
Experimental: 5-Minute Administration ("5-min"-group); 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: near-infrared spectroscopy; preterm neonates; cerebral oxygenation; surfactant; LISA; surfactant administration; less-invasive surfactant administration
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis; Health Services Administration; Organization and Administration; poractant alfa
• Other Study ID Numbers: SurfStab I Trial; 2025-522754-39-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No