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

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ClinicalTrials.gov Identifier: NCT03235986
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neonatal Respiratory Distress Syndrome Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I) Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II) Other: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I) Other: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: nCPAP+ Nebulised Curosurf®
Curosurf® administered through nebulization
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)

nCPAP alone (control)
Standard of care, respiratory support used also during experimental arms
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




Primary Outcome Measures :
  1. Percentage of neonates with respiratory failure [ Time Frame: in the first 72 hours of life ]
    Respiratory failure defined as: need for endotracheal surfactant administration and/or mechanical ventilation

  2. Adverse Events [ Time Frame: 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

  3. Adverse Drug Reactions [ Time Frame: 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



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Ages Eligible for Study:   28 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235986


Contacts
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Contact: Chiesi Clinical Trial Info +3905212791 clinicaltrials_info@chiesi.com

Locations
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Italy
Prof.Carlo Dani, Coordinating Investigator - Careggi Hospital, Florence (Italy) Recruiting
Firenze, Italy, 50134
Contact: Carlo Dani, MD       carlo.dani@unifi.it   
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Carlo Dani, MD Careggi Hospital, Florence (Italy)

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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT03235986     History of Changes
Other Study ID Numbers: CCD-01534CA1-01
2016-004547-36 ( EudraCT Number )
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chiesi Farmaceutici S.p.A.:
RDS
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Poractant alfa
Pulmonary Surfactants
Respiratory System Agents