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

NCT ID: NCT07261787

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-12-01

Brief 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. 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.

Conditions

Neonates and Preterm Infants; Infant Respiratory Distress Syndrome; Surfactant Deficiency Syndrome Neonatal; Surfactant; Cerebral Oxygenation; Cerebral Oxygen Saturation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1-Minute Administration ("1-min"-group)

Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 1 minute.

Group Type: EXPERIMENTAL

Poractant alfa (Curosurf®) - 1-minute administration

Intervention Type: 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.

5-Minute Administration ("5-min"-group)

Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 5 minutes.

Group Type: EXPERIMENTAL

Poractant alfa (Curosurf®) - 5-minute administration

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Christina Wolfsberger, MD

Priv.Doz. DDr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Graz, Division of Neonatology, Department of Pediatrics and Adolescent Medicine

Graz, , Austria

Countries

Austria

Central Contacts

Christina H. Wolfsberger, Priv.Doz. DDr.

Role: CONTACT

christina.wolfsberger@medunigraz.at

+43 316 385 81135

Gerhard Pichler, Univ.Prof. PD. Dr.

Role: CONTACT

gerhard.pichler@medunigraz.at

+43 316 385 80520

Other Identifiers

2025-522754-39-00

Identifier Type: CTIS

Identifier Source: secondary_id

SurfStab I Trial

Identifier Type: -

Identifier Source: org_study_id