Back to resultsA Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)
Primary Purpose
Neonatal Respiratory Distress Syndrome
Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I)
nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II)
nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I)
nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Respiratory Distress Syndrome focused on measuring RDS
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Prof.Carlo Dani, Coordinating Investigator - Careggi Hospital, Florence (Italy)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
nCPAP+ Nebulised Curosurf®
nCPAP alone (control)
Arm Description
Curosurf® administered through nebulization
Standard of care, respiratory support used also during experimental arms
Outcomes
Primary Outcome Measures
Percentage of neonates with respiratory failure
Respiratory failure defined as: need for endotracheal surfactant administration and/or mechanical ventilation
Adverse Events
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
Any untoward and unintended responses to an investigational product related to any dose administered
Secondary Outcome Measures
Full Information
NCT ID
NCT03235986
First Posted
July 26, 2017
Last Updated
March 16, 2022
Sponsor
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT03235986
Brief Title
A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)
Official Title
A Randomized, Open, Multinational, Multicentre,2-Part Study In Spontaneously Breathing Preterm Neonates With Mild To Moderate Respiratory Distress Syndrome (RDS) To Investigate The Safety, Tolerability And Efficacy Of Inhaled Nebulised Poractant Alfa (Porcine Surfactant, Curosurf®) In Comparison With Nasal Continuous Positive Airway Pressure (nCPAP) Alone
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Change in the benefit-risk balance
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
May 5, 2020 (Actual)
Study Completion Date
May 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Respiratory Distress Syndrome
Keywords
RDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nCPAP+ Nebulised Curosurf®
Arm Type
Experimental
Arm Description
Curosurf® administered through nebulization
Arm Title
nCPAP alone (control)
Arm Type
Other
Arm Description
Standard of care, respiratory support used also during experimental arms
Intervention Type
Drug
Intervention Name(s)
nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I)
Intervention Description
Single ascending doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part I)
Intervention Type
Drug
Intervention Name(s)
nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II)
Intervention Description
Two doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part II)
Intervention Type
Other
Intervention Name(s)
nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I)
Intervention Description
Nasal continuous positive airway pressure alone
Intervention Type
Other
Intervention Name(s)
nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)
Intervention Description
nasal continuous positive airway pressure alone
Primary Outcome Measure Information:
Title
Percentage of neonates with respiratory failure
Description
Respiratory failure defined as: need for endotracheal surfactant administration and/or mechanical ventilation
Time Frame
in the first 72 hours of life
Title
Adverse Events
Description
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
Time Frame
discharge or 36 weeks post menstrual age (PMA), whichever comes first
Title
Adverse Drug Reactions
Description
Any untoward and unintended responses to an investigational product related to any dose administered
Time Frame
discharge or 36 weeks post menstrual age (PMA), whichever comes first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Dani, MD
Organizational Affiliation
Careggi Hospital, Florence (Italy)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof.Carlo Dani, Coordinating Investigator - Careggi Hospital, Florence (Italy)
City
Firenze
ZIP/Postal Code
50134
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35257740
Citation
Dani C, Talosi G, Piccinno A, Ginocchio VM, Balla G, Lavizzari A, Stranak Z, Gitto E, Martinelli S, Plavka R, Krolak-Olejnik B, Lista G, Spedicato F, Ciurlia G, Santoro D, Sweet D; CURONEB Study Group. A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome. J Pediatr. 2022 Jul;246:40-47.e5. doi: 10.1016/j.jpeds.2022.02.054. Epub 2022 Mar 5.
Results Reference
result
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004547-36/results
Description
Study Record on EU Clinical Trials Register including results
Learn more about this trial
A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)
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