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NCT Number: NCT07261787

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

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).

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Key information

Conditions

Neonates and Preterm Infants Cerebral Oxygen Saturation Cerebral Oxygenation Infant Respiratory Distress Syndrome Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases Surfactant Surfactant Deficiency Syndrome Neonatal

Age range

0 month–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Graz, 8036, Austria

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in cerebral oxygenation (crSO₂) during and after LISA

    Time frame: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter

    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.

Secondary outcomes

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

    Time frame: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter

    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.

  2. Change in heart rate (HR) during and after LISA

    Time frame: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter

    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.

  3. Change in crSO2 up to three hours after LISA

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

    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.

  4. Change in SpO2 up to three hours after LISA

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

    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.

  5. Change in HR up to three hours after LISA

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

    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.

  6. Change in mean arterial blood pressure (MABP) up to three hours after LISA

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

    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.

  7. Amount of bradycardia

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

    The secondary outcome measure will be the amount of bradycardia (in minutes) up to three hours after surfactant administration

  8. Amount of cerebral hypoxia

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

    The secondary outcome measure will be the amount of cerebral hypoxia (in minutes) up to three hours after surfactant administration

  9. Amount of systemic hypoxia

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

    The secondary outcome measure will be the amount of systemic hypoxia (in minutes) up to three hours after surfactant administration

  10. Amount of supplemental oxygen

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

    The secondary outcome measure will be the amount of supplemental oxygen up to three hours after surfactant administration

  11. Need for repeat surfactant administraiton

    Time frame: Within 48 hours after first LISA procedure

    Proportion of infants requiring a second surfactant dose as per clinical indication.

  12. Need for invasive ventilation

    Time frame: Within 48 hours after first LISA procedure

    Proportion of infants requiring intubation and mechanical ventilation due to respiratory failure.

  13. Bronchopulmonary dysplasia (BPD)

    Time frame: At 36 weeks corrected gestational age

    Incidence of BPD, defined as oxygen and/or respiratory support requirement at 36 weeks postmenstrual age.

  14. Intraventricular haemorrhage (IVH)

    Time frame: At 40 weeks of corrected age

    Incidence of any IVH assessed by cranial ultrasound

  15. Periventricular leukomalacia (PVL)

    Time frame: At 40 weeks of corrected age

    Presence of cystic PVL or increased periventricular echogenicity consistent with white matter injury.

  16. Retinopathy of prematurity

    Time frame: At 40 weeks of corrected age

    Presence of ROP

  17. Necrotizing enterocolitis (NEC)

    Time frame: At 40 weeks of corrected age

    Presence of NEC

  18. Mortality

    Time frame: At 40 weeks of corrected age

    Occurence of mortality during hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Christina H. Wolfsberger, Priv.Doz. DDr.

CONTACT

[email protected]

+43 316 385 81135

Gerhard Pichler, Univ.Prof. PD. Dr.

CONTACT

[email protected]

+43 316 385 80520

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Acronym: SurfStab I

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 3, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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