Actively Recruiting

Phase 4
Age: 0Months - 72Hours
All Genders
NCT07261787

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

Led by Medical University of Graz · Updated on 2026-05-14

76

Participants Needed

1

Research Sites

145 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Months - 72Hours
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm neonate less than 28 weeks gestational age (up to 27 weeks and 6 days)
  • Indication for surfactant administration via the LISA method
  • Postnatal age less than 72 hours
Not Eligible

You will not qualify if you...

  • Receiving invasive ventilation or indication for INSURE procedure
  • Severe lung or heart malformations affecting oxygenation or congenital brain malformation
  • Preexisting diagnosis of brain hemorrhage greater than grade 2 or periventricular hemorrhagic infarction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Graz, Austria, 8036

Actively Recruiting

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Research Team

C

Christina H. Wolfsberger, Priv.Doz. DDr.

CONTACT

G

Gerhard Pichler, Univ.Prof. PD. Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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