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

Medical University of Graz

Status and phase: Not yet enrolling; Phase 4

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

Treatments: Drug: Poractant alfa (Curosurf®) - 1-minute administration; Drug: Poractant alfa (Curosurf®) - 5-minute administration

Study type: Interventional

Funder types: Other

Identifiers

NCT07261787

SurfStab I Trial

2025-522754-39-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: Under 72 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Poractant alfa (Curosurf®) - 1-minute administration

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

Experimental group

Description:

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

Treatment:

Drug: Poractant alfa (Curosurf®) - 5-minute administration