A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)

Chiesi

Status and phase: Terminated; Phase 2

Conditions: Neonatal Respiratory Distress Syndrome

Treatments: Other: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I); Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II); Other: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II); Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03235986

CCD-01534CA1-01

2016-004547-36 (EudraCT Number)

Details and patient eligibility

About

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 (Respiratory Distress Syndrome) during nCPAP.

Full 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 single ascending doses of nebulised Curosurf® ; Part II, with the objective to compare the efficacy of nebulised Curosurf®, administered at two selected doses from part I, during nCPAP, versus nCPAP alone in terms of incidence of respiratory failure in the first 72 hours of life.

Enrollment: 166 patients

Sex: All

Ages: 28 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth
2. Inborn neonates from 28+0 to 32+6 weeks of gestational age (GA), spontaneously breathing and stabilised on nCPAP
3. Clinical course consistent with RDS.
4. 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 criteria

1. Early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe RDS
2. Respiratory Distress not secondary to surfactant deficiency
3. Use of surfactant prior to study entry and need for endotracheal administration of any other treatment.
4. Major congenital anomalies.
5. Evidence of severe birth asphyxia
6. Mothers with prolonged rupture of the membranes
7. Presence of air leaks.
8. Presence of IVH (intraventricular hemorrhage ) ≥ III.
9. Hypotension or evidence of hemodynamic instability.
10. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk.
11. Participation in another clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

nCPAP+ Nebulised Curosurf®

Experimental group

Description:

Curosurf® administered through nebulization

Treatment:

Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I)

Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II)

nCPAP alone (control)

Other group

Description:

Standard of care, respiratory support used also during experimental arms

Treatment:

Other: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I)

Other: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)