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

NCT03235986 | Terminated Phase 2 DMC

• 2 other identifiers: CCD-01534CA1-012016-004547-36
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Respiratory Distress Syndrome

Keywords

RDS

Outcome Measures

Primary Outcomes (3)

• Percentage of neonates with respiratory failure

  Respiratory failure defined as: need for endotracheal surfactant administration and/or mechanical ventilation

  in the first 72 hours of life

• 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

  discharge or 36 weeks post menstrual age (PMA), whichever comes first

• Adverse Drug Reactions

  Any untoward and unintended responses to an investigational product related to any dose administered

  discharge or 36 weeks post menstrual age (PMA), whichever comes first

Study Arms (2)

nCPAP+ Nebulised Curosurf®

EXPERIMENTAL

Curosurf® administered through nebulization

Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I); Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II)

nCPAP alone (control)

OTHER

Standard of care, respiratory support used also during experimental arms

Other: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I); Other: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)

Interventions

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

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

nCPAP+ Nebulised Curosurf®

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

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

nCPAP+ Nebulised Curosurf®

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

Nasal continuous positive airway pressure alone

nCPAP alone (control)

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

nasal continuous positive airway pressure alone

nCPAP alone (control)

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Prof.Carlo Dani, Coordinating Investigator - Careggi Hospital, Florence (Italy)

Florence, 50134, Italy

Location

Related Publications (1)

• 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.

  PMID: 35257740 RESULT

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

Continuous Positive Airway Pressure; Single Person

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Carlo Dani, MD

  Careggi Hospital, Florence (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 1, 2017
• Study Start: August 28, 2017
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)