A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)

PHASE2CompletedINTERVENTIONAL
Enrollment

123

Participants

Timeline

Start Date

January 21, 2016

Primary Completion Date

May 24, 2018

Study Completion Date

May 24, 2018

Conditions
Respiratory Distress Syndrome, Newborn
Interventions
DRUG

CHF5633

Rescue treatment (if needed)

DRUG

Poractant alfa

Rescue treatment (if needed)

Trial Locations (23)

Unknown

University of South Alabama - USA Children's and Women's Hospital, Mobile

LAC + USC Medical Center, Keck School of Medicine, Los Angeles

UC Irvine Medical Center, Orange

Sharp Mary Birch Hospital, San Diego

Connecticut Children's Medical Center, Hartford

Plantation General Hospital (Sheridan Clinical Research, Inc.), Plantation

Jatinder Bhatia, Augusta

Indiana University School of Medicine, Indianapolis

Memorial Hospital of South Bend, South Bend

University of Louisville Research Foundation, Inc., Louisville

Baystate Children's Hospital / Baystate Medical Center, Springfield

Winthrop University Hospital, Mineola

Kings County Hospital Center, New York

Sergio G. Golombek, Valhalla

Martha Naylor, Greenville

Cincinnati Children's Hospital Medical Center, Cincinnati

Case Western Reserve University, Cleveland

Krishnamurthy Sekar, Oklahoma City

Hahnemann University Hospital, Philadelphia

Texas Tech University Health Sciences Center, El Paso

MultiCare Institute for Research & Innovation, Tacoma

West Virginia University, Morgantown

02111

Floating Hospital for Children at Tufts Medical Center, Boston

All Listed Sponsors
lead

Chiesi Farmaceutici S.p.A.

INDUSTRY

NCT02452476 - A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC) | Biotech Hunter | Biotech Hunter