Status:
TERMINATED
A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Neonatal Respiratory Distress Syndrome
Eligibility:
All Genders
28-32 years
Phase:
PHASE2
Brief Summary
The present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised Curosurf®, in preterm neonates with RDS (Respi...
Detailed Description
The study will be conducted in spontaneously breathing preterm neonates with mild to moderate RDS and will consist of two parts: Part I, with the objective to assess the safety and tolerability of si...
Eligibility Criteria
Inclusion
- Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth
- Inborn neonates from 28+0 to 32+6 weeks of gestational age (GA), spontaneously breathing and stabilised on nCPAP
- Clinical course consistent with RDS.
- Receiving CPAP pressure 5-8 centimeter of water (cm H2O) and fraction of inspired oxygen (FiO2) between 0.25 and 0.40 to maintain saturation of peripheral oxygen (SpO2) between 88% and 95% for at least 30 minutes. Randomization should occur between 60 minutes and 12 hours after birth.
Exclusion
- Early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe RDS
- Respiratory Distress not secondary to surfactant deficiency
- Use of surfactant prior to study entry and need for endotracheal administration of any other treatment.
- Major congenital anomalies.
- Evidence of severe birth asphyxia
- Mothers with prolonged rupture of the membranes
- Presence of air leaks.
- Presence of IVH (intraventricular hemorrhage ) ≥ III.
- Hypotension or evidence of hemodynamic instability.
- Any condition that, in the opinion of the Investigator, would place the neonate at undue risk.
- Participation in another clinical trial
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2020
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT03235986
Start Date
August 28 2017
End Date
May 5 2020
Last Update
March 31 2022
Active Locations (1)
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1
Prof.Carlo Dani, Coordinating Investigator - Careggi Hospital, Florence (Italy)
Florence, Italy, 50134