A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration

Launched by CHIESI FARMACEUTICI S.P.A. · May 11, 2016

Keywords

ClinConnect Summary

This study was an open-label, multicentre, randomized, controlled study of spontaneously breathing neonates with RDS. Neonates were evaluated according to the selection criteria and then randomized to surfactant treatment via LISA or standard administration procedure. The enrolment was staggered: the gestational age was restricted to 27+0 weeks up to 28+6 weeks for the first 15 neonates. Provided no safety concerns were raised, the enrolment was planned to be extended to the whole population (i.e. 25+0 weeks up to 28+6 weeks). Enrolled neonates were evaluated in a main phase of the trial un...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth
• • 2. Preterm neonates of either sex aged ≥30 minutes and \<24 hours, spontaneously breathing and stabilized on non-invasive ventilation (NIV).
• • 3. Gestational age of 25+0 weeks up to 28+6 completed weeks, except for the first 15 enrolled neonates in which the gestational age will be restricted to 27+0 weeks up to 28+6 weeks.
• • 4. Clinical course consistent with RDS.
• • 5. Fraction of inspired oxygen (FiO2) ≥0.30 to maintain preductal oxygen saturation (SpO2) between 88-95%.
• Exclusion Criteria:
• • 1. Need for immediate endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive
• • 2. Use of nasal high frequency oscillatory ventilation (nHFOV) prior to study entry
• • 3. Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
• • 4. Known genetic or chromosomal disorders, major congenital anomalies (congenital heart diseases, myelomeningocele etc)
• • 5. Mothers with prolonged rupture of the membranes (\> 21 days duration)
• • 6. Presence of air leaks if identified and known prior to study entry
• • 7. Evidence of severe birth asphyxia (e.g. continued need for resuscitation at 10 minutes after birth, altered neurological state, or neonatal encephalopathy)
• • 8. Neonatal seizures prior to study entry
• • 9. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
• • 10. Participation in another clinical trial of any medicinal product, placebo, experimental medical device, or biological substance conducted under the provisions of a protocol on the same therapeutic target.