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

Phase 2

Terminated

• Conditions: Neonatal Respiratory Distress Syndrome
• Interventions: Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I); 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)

• Registration Number: NCT03235986
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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 (Respiratory Distress Syndrome) during nCPAP.

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 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.

Study Timeline

• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-01
• Study Start: 2017-08-28
• Primary Completion: 2020-05-05
• Study Completion: 2020-05-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nCPAP+ Nebulised Curosurf®	nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I)	Curosurf® administered through nebulization
nCPAP+ Nebulised Curosurf®	nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II)	Curosurf® administered through nebulization
nCPAP alone (control)	nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I)	Standard of care, respiratory support used also during experimental arms
nCPAP alone (control)	nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)	Standard of care, respiratory support used also during experimental arms

Primary Outcome Measures

Name	Time	Method
Adverse Events	discharge or 36 weeks post menstrual age (PMA), whichever comes first	Any untoward medical occurrence in a clinical trial neonate administered a medicinal product and which does not necessarily have a casual relationship with the treatment
Adverse Drug Reactions	discharge or 36 weeks post menstrual age (PMA), whichever comes first	Any untoward and unintended responses to an investigational product related to any dose administered
Percentage of neonates with respiratory failure	in the first 72 hours of life	Respiratory failure defined as: need for endotracheal surfactant administration and/or mechanical ventilation

Trial Locations

Locations (1)

Prof.Carlo Dani, Coordinating Investigator - Careggi Hospital, Florence (Italy); 🇮🇹 Firenze, Italy