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

Phase 2 Terminated 166 enrolled Chiesi Farmaceutici S.p.A.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2017-08-28
Primary completion: 2020-05-05
Completion: 2020-05-05

Outcome

Missed primary endpoint

Stopped: “Change in the benefit-risk balance”

paper CONCLUSIONS: The intervention did not decrease the likelihood of respiratory failure within the first 72 hours of life. PMID 35257740 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Poractant alfa	Other / unclassified	200 mg/kg	Inhaled
Subject	Poractant alfa	Other / unclassified	400 mg/kg	Inhaled