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

Neonatal Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03235986
• Other study ID #: CCD-01534CA1-01
• Secondary ID: 2016-004547-36
• Status: Terminated
• Phase: Phase 2
• Start date: August 28, 2017
• Est. completion date: May 5, 2020

Study information

• Verified date: March 2022
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 166
• Est. completion date: May 5, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Neonatal Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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)
• 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
• nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)
nasal continuous positive airway pressure alone

Locations

Country	Name	City	State
Italy	Prof.Carlo Dani, Coordinating Investigator - Careggi Hospital, Florence (Italy)	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Italy, 

References & 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 Eff — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   Study Record on EU Clinical Trials Register including results