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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-28

Study Completion Date

2020-05-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neonatal Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part I is an ascending dose scheme of IMP versus nCPAP alone. Part II is a parallel group with 2 doses of IMP versus nCPAP alone. In part II, one additional dose may be administered between 3 and 12 hours after the start of the first dose.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nCPAP+ Nebulised Curosurf®

Curosurf® administered through nebulization

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Single ascending doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part I)

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

Intervention Type DRUG

Two doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part II)

nCPAP alone (control)

Standard of care, respiratory support used also during experimental arms

Group Type OTHER

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

Intervention Type OTHER

Nasal continuous positive airway pressure alone

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

Intervention Type OTHER

nasal continuous positive airway pressure alone

Interventions

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

Single ascending doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part I)

Intervention Type DRUG

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

Two doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part II)

Intervention Type DRUG

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

Nasal continuous positive airway pressure alone

Intervention Type OTHER

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

nasal continuous positive airway pressure alone

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No