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First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome

Respiratory Distress Syndrome in Premature Infants Clinical Trial

Official title:
A First in Human Clinical Study on the Safety and Tolerability of Two Escalating Single Doses of CHF 5633 (Synthetic Surfactant) in Preterm Neonates With Respiratory Distress Syndrome

Clinical Trial Summary

The aim of this study is to investigate the safety and tolerability of intratracheal administration of two different single doses of CHF 5633 in preterm neonates with RDS in terms of adverse events, adverse drug reactions, hematology and biochemistry values, the incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and mortality.

Clinical Trial Description

The study will be a multicentre, open-label, single escalating dose, per-cohort design. ;

Study Design

Related Conditions & MeSH terms

  • Respiratory Distress Syndrome in Premature Infants
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Syndrome
Clinical Trial Details
NCT number NCT01651637
Study type Interventional
Source Chiesi Farmaceutici S.p.A.
Contact
Status Completed
Phase Phase 1
Start date October 2012
Completion date January 23, 2015
View Details
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