Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

October 31, 2015

Study Completion Date

November 30, 2015

Conditions
Respiratory Distress Syndrome
Interventions
DRUG

Lucinactant for Inhalation

Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)

DEVICE

nCPAP alone

nCPAP therapy

Trial Locations (11)

19713

Christiana Care Health System, Newark

27710

Duke University Medical Center, Durham

33136

University of Miami, Miami

35249

University of Alabama at Birmingham, Birmingham

40202

University of Louisville, Louisville

46202

Riley Hospital for Children at IU Health, Indianapolis

72202

Arkansas Children's Hospital, Little Rock

92123

Sharp Mary Birch Hospital for Women and Newborns, San Diego

92354

Loma Linda University Medical Center, Loma Linda

97225

Providence St. Vincent Medical Center, Portland

07960

Mid Atlantic Neonatology Associates, Morristown

Sponsors
All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Windtree Therapeutics

INDUSTRY

NCT02074059 - Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates | Biotech Hunter | Biotech Hunter