Clinical Trial Results:
An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates with Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (poractant alfa, Curosurf®) Administration: a Less Invasive Method (LISA) During Non-Invasive Ventilation (NIV) and the Conventional Administration During Brief Invasive Ventilation.
Summary
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EudraCT number |
2016-001974-14 |
Trial protocol |
Outside EU/EEA |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Sep 2023
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First version publication date |
09 Sep 2023
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Other versions |
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Summary report(s) |
CCD-050000-01 LISPAP CSR SYNOPSIS |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.