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

NCT07261787 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: SurfStab I Trial2025-522754-39-00
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

surfactant; surfactant administration; LISA; less-invasive surfactant administration; preterm neonates; cerebral oxygenation; near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Change in arterial oxygen saturation (SpO₂) during and after LISA

  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

  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

  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

  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

  Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure

Study Arms (2)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

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.

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

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.

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

Eligibility Criteria

• Age: 0 Months - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

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

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

poractant alfa; Organization and Administration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Services Administration

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.Doz. DDr.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)