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

Study Identifier:
CCD-1011-PR-0059
ClinicalTrials.gov Identifier:
NCT01651637
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Study Details

Medical Condition
  • Neonatal Respiratory Distress Syndrome
Study Drug
  • Drug: synthetic surfactant (CHF5633)
Date
Oct 2012 - Jan 2015
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 27 - 34 Weeks
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures
  • Inborn and outborn, preterm neonates of either sex with a gestational age of 27 weeks up to 33 weeks+6
  • Clinical and radiological findings typical of RDS
  • Age on admission to the study \< 24 hours from birth
  • Requirement of endotracheal intubation for surfactant administration
  • Fraction of inspired oxygen (FiO2) \> 0.35 to maintain SpO2 between 90-95 %
  • Documentation of normal cranial ultrasound scan
Exclusion Criteria
  • Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
  • Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)
  • Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy
  • Clinical chorioamnionitis (Appendix III)
  • Strong suspicion of congenital pneumonia/infection, sepsis
  • Evidence of severe birth asphyxia or a 5 minutes Apgar score less / equal 3
  • Presence of air leaks prior to study entry
  • Neonatal seizures prior to study entry
  • Mothers with prolonged rupture of the membranes (\> 3 weeks duration)
  • Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
  • Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol
Healthy Volunteers
No

Protocol 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.

Study Locations

Location
Status
Location
Liverpool Women's Hospital Neonatal Unit Liverpool Women's Hospital
Liverpool, United Kingdom
Status
N/A

Study Publications

Sweet DG, Turner MA, Stranak Z, Plavka R, Clarke P, Stenson BJ, Singer D, Goelz R, Fabbri L, Varoli G, Piccinno A, Santoro D, Speer CP. A first-in-human clinical study of a new SP-B and SP-C enriched synthetic surfactant (CHF5633) in preterm babies with respiratory distress syndrome. Arch Dis Child Fetal Neonatal Ed. 2017 Nov;102(6):F497-F503. doi: 10.1136/archdischild-2017-312722. Epub 2017 May 2.