A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration

Study Identifier:
CCD-050000-01
ClinicalTrials.gov Identifier:
NCT02772081
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Terminated/Withdrawn

Trial Documents

Protocol
Available Languages: English
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Statistical Analysis Plan
Available Languages: English
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Plain Language Summary
Available Languages: English
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Study Details

Medical Condition
  • Neonatal Respiratory Distress Syndrome
Study Drug
  • Drug: Curosurf through conventional administration (endotracheal tube)
Date
May 2021 - Aug 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 30 Minutes - 24 Hours
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
  • Preterm neonates of either sex aged ≥30 minutes and \<24 hours, spontaneously breathing and stabilized on non-invasive ventilation (NIV).
  • Gestational age of 25+0 weeks up to 28+6 completed weeks, except for the first 15 enrolled neonates in which the gestational age will be restricted to 27+0 weeks up to 28+6 weeks.
  • Clinical course consistent with RDS.
  • Fraction of inspired oxygen (FiO2) ≥0.30 to maintain preductal oxygen saturation (SpO2) between 88-95%.
Exclusion Criteria
  • Need for immediate endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive
  • Use of nasal high frequency oscillatory ventilation (nHFOV) prior to study entry
  • 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 (congenital heart diseases, myelomeningocele etc)
  • Mothers with prolonged rupture of the membranes (\> 21 days duration)
  • Presence of air leaks if identified and known prior to study entry
  • Evidence of severe birth asphyxia (e.g. continued need for resuscitation at 10 minutes after birth, altered neurological state, or neonatal encephalopathy)
  • Neonatal seizures prior to study entry
  • Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
  • Participation in another clinical trial of any medicinal product, placebo, experimental medical device, or biological substance conducted under the provisions of a protocol on the same therapeutic target.
Healthy Volunteers
No

Protocol Summary

This study compared the administration of porcine surfactant (poractant alfa, Curosurf®) through a less invasive method (LISA), using a thin catheter, CHF 6440 (LISACATH®), during non-invasive ventilation (CPAP, NIPPV, BiPAP) with an approved conventional surfactant administration during invasive ventilation followed by rapid extubation in terms of short term and mid-term safety and efficacy in spontaneously breathing preterm neonates who have clinical signs of respiratory distress syndrome (RDS).

Study Locations

Location
Status
Location
Chiesi Clinical Trial Site 84029
Little Rock, Arkansas, United States, 72205
Status
N/A
Location
Chiesi Clinical Trial Site 84001
Los Angeles, California, United States, 90033
Status
N/A
Location
Chiesi Clinical Trial Site 84002
Los Angeles, California, United States, 90033
Status
N/A
Location
Chiesi Clinical Trial Site 84013
Denver, Colorado, United States, 80204
Status
N/A
Location
Chiesi Clinical Trial Site 84026
New Britain, Connecticut, United States, 06052
Status
N/A
Location
Chiesi Clinical Trial Site 84003
Evanston, Illinois, United States, 60201
Status
N/A
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