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

NCT03235986 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

  • Neonatal Respiratory Distress Syndrome

Interventions

DRUG

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

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

DRUG

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

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

OTHER

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

Nasal continuous positive airway pressure alone

OTHER

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

nasal continuous positive airway pressure alone

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Carlo Dani, MD · Careggi Hospital, Florence (Italy)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2020-05-05
Completion
2020-05-05

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03235986 on ClinicalTrials.gov