Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome
Recruiting
Phase 4
Interventional Study
Respiratory Distress Syndrome in Premature Infants
Respiratory Distress Syndrome (RDS)
Surfactant
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 Hours – 6 Hours
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 234 (estimated)
- Sponsor
- Uludag University · Other
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About This Trial
Respiratory distress syndrome (RDS) is a common cause of respiratory failure in preterm infants and is frequently treated with surfactant therapy. With the increasing use of noninvasive ventilation, less invasive methods of surfactant administration have been developed. In the technique known as Less Invasive Surfactant Administration (LISA), surfactant is delivered into the trachea through a thin…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Born at a participating study center hospital.
* Gestational age between 24 1/7 and 29 6/7 weeks (\<30 0/7 weeks).
* Postnatal age within the first 6 hours of life.
* Being on non-invasive respiratory support.
* Presence of clinical and radiological findings consistent with re…
Contacts