Phase
Condition
Lung Injury
Respiratory Failure
Treatment
LISA combination product (Curosurf+catheter CHF6440)
Curosurf through conventional administration (endotracheal tube)
Clinical Study ID
Ages 30-24 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent obtained by parents/legal representative (according to localregulation) prior to or after birth
- Preterm neonates of either sex aged ≥30 minutes and <24 hours, spontaneously breathingand stabilized on non-invasive ventilation (NIV).
- Gestational age of 25+0 weeks up to 28+6 completed weeks, except for the first 15enrolled 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
Exclusion Criteria:
- Need for immediate endotracheal intubation for cardiopulmonary resuscitation orinsufficient 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 ofany other treatment (e.g. nitric oxide)
- Known genetic or chromosomal disorders, major congenital anomalies (congenital heartdiseases, 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 minutesafter 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 atundue risk
- Participation in another clinical trial of any medicinal product, placebo,experimental medical device, or biological substance conducted under the provisions ofa protocol on the same therapeutic target.
Study Design
Study Description
Connect with a study center
NICU Children's Hospital "V. Buzzi", ICP
Milan, Lombardia 20153
ItalySite Not Available
Chiesi Clinical Trial Site 84029
Little Rock, Arkansas 72205
United StatesSite Not Available
Chiesi Clinical Trial Site 84001
Los Angeles, California 90033
United StatesSite Not Available
Chiesi Clinical Trial Site 84002
Los Angeles, California 90033
United StatesSite Not Available
Chiesi Clinical Trial Site 84013
Denver, Colorado 80204
United StatesSite Not Available
Chiesi Clinical Trial Site 84014
Farmington, Connecticut 06032
United StatesSite Not Available
Chiesi Clinical Trial Site 84026
New Britain, Connecticut 06052
United StatesSite Not Available
Chiesi Clinical Trial Site 84003
Evanston, Illinois 60201
United StatesSite Not Available
Chiesi Clinical Trial Site 84021
Peoria, Illinois 61637
United StatesSite Not Available
Chiesi Clinical Trial Site 84023
Lexington, Kentucky 40506
United StatesSite Not Available
Chiesi Clinical Trial Site 84028
Springfield, Massachusetts 01199
United StatesSite Not Available
Chiesi Clinical Trial Site 84005
Worcester, Massachusetts 01605
United StatesSite Not Available
Chiesi Clinical Trial Site 84008
Lansing, Michigan 48912
United StatesSite Not Available
Chiesi Clinical Trial Site 84004
Saint Louis, Missouri 63104
United StatesSite Not Available
Chiesi Clinical Trial Site 84012
Camden, New Jersey 08103
United StatesSite Not Available
Chiesi Clinical Trial Site 84024
Manhasset, New York 11030
United StatesSite Not Available
Chiesi Clinical Trial Site 84019
New Hyde Park, New York 11040
United StatesSite Not Available
Chiesi Clinical Trial Site 84009
Valhalla, New York 10595
United StatesSite Not Available
Chiesi Clinical Trial Site 84027
Greenville, North Carolina 27858
United StatesSite Not Available
Chiesi Clinical Trial Site 84010
Wilmington, North Carolina 28401
United StatesSite Not Available
Chiesi Clinical Trial Site 84025
Cincinnati, Ohio 45229
United StatesSite Not Available
Chiesi Clinical Trial Site 84017
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Chiesi Clinical Trial Site 84020
Hershey, Pennsylvania 17033
United StatesSite Not Available
Chiesi Clinical Trial Site 84007
Nashville, Tennessee 37212
United StatesSite Not Available
Chiesi Clinical Trial Site 84016
Houston, Texas 77030
United StatesSite Not Available
Chiesi Clinical Trial Site 84011
Lubbock, Texas 79410
United StatesSite Not Available
Chiesi Clinical Trial Site 84006
Plano, Texas 75075
United StatesSite Not Available
Chiesi Clinical Trial Site 84022
Temple, Texas 76502
United StatesSite Not Available
Chiesi Clinical Trial Site 84015
Charlottesville, Virginia 22908
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.