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

Study Identifier:
CCD-01534CA1-01
ClinicalTrials.gov Identifier:
NCT03235986
EudraCT Identifier:
2016-004547-36
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Terminated/Withdrawn

Study Details

Medical Condition
  • Neonatal Respiratory Distress Syndrome
Study Drug
  • Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I)
  • Drug: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II)
Date
Aug 2017 - May 2020
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 28 - 32 Weeks
Requirements Information
Inclusion and Exclusion 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
Healthy Volunteers
No

Protocol 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.

Study Locations

Location
Status
Location
Prof.Carlo Dani, Coordinating Investigator - Careggi Hospital, Florence (Italy)
Florence, Italy, 50134
Status
N/A

Study Publications

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.