Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
Recruiting
Phase 4
Interventional Study
Neonates and Preterm Infants
Infant Respiratory Distress Syndrome
Surfactant Deficiency Syndrome Neonatal
Surfactant
Cerebral Oxygenation
Cerebral Oxygen Saturation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 Months – 72 Hours
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 76 (estimated)
- Sponsor
- Medical University of Graz · Other
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About This Trial
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 …
Trial Locations
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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 malform…
Contacts
Christina H. Wolfsberger, Priv.Doz. DDr.
+43 316 385 81135
christina.wolfsberger@medunigraz.at
CONTACT