The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age

PHASE2CompletedINTERVENTIONAL
Enrollment

221

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

July 31, 2017

Study Completion Date

August 6, 2019

Conditions
Respiratory Distress Syndrome
Interventions
DRUG

Lucinactant delivered via investigational delivery device

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

DRUG

nCPAP

Nasal CPAP

Trial Locations (54)

1082

Semmelweis Egyetem, Budapest

3330

Hospital San Jose, Santiago

3526

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Okato, Miskolc

4032

Csolnoky Ferenc Korhaz, Debrecen

10032

Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY), New York

12208

Albany Medical Center, Albany

19713

Christiana Care Health System, Newark

27710

Duke University Medical Center, Durham

27834

Brody School of Medicine at ECU, Greenville

28401

New Hanover Regional Medical Center, Wilmington

33136

University of Miami Holtz Children's Hospital, Miami

35249

University of Alabama at Birmingham, Birmingham

39216

University of Mississippi Medical Center, Jackson

43210

Ohio State University, Columbus

44106

Case Western Reserve University (Rainbow Babies Hosp.), Cleveland

48109

University of Michigan Health System, Ann Arbor

68105

University of Nebraska Medical Center, Omaha

72202

Univ. of Arkansas Medical Center, Little Rock

75246

Baylor University Medical Center, Dallas

76104

Cook Children's Hospital, Fort Worth

Texas Health Harris Methodist Hospital, Fort Worth

92123

Sharp Mary Birch Hospital for Women and Newborns, San Diego

92354

Loma Linda University Medical Center, Loma Linda

92868

Children's Hospital of Orange County, Orange

97225

Providence St. Vincent Medical Center, Portland

760032

Fundacion Valle Del Lili, Santiago de Cali

4070038

Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente, Concepción

7650568

Clinica Alamena de Santiago, Santiago

7980378

Hospital Santiago Oriente Dr Luis Tisné Brousse, Santiago

8207257

Hospital Dr Sotero Del Rio, Santiago

8330024

Hospital Clinico de la Pontificia Universidad Catolica de Chile, Santiago

8350488

Hospital San Juan de Dios, Santiago

02905

Women and Infants Hospital, Providence

T2N 2T9

Foothills Medical Centre, Calgary

T5H 3V9

Royal Alexandra Hospital, Edmonton

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

H3H 1P3

Montreal Children's Hospital, Montreal

H3T 1C5

Sainte Justine Hospital, Montreal

050010

Fundacion Hospitalaria San Vicente de Paul, Medellín

050015

Hospital General de Medellin, Medellín

H-4012

Debreceni Egyetem Klinikai Kozpont, Debrecen

H-4400

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza

T12 YN60

Cork University Hospital, Cork

Unknown

Mid-Western Regional Hospital Limerick, Limerick

3000 CB

Erasmus Medical Center, Rotterdam

60-535

Ginekologiczno-Polozniczy Szpital Klinicznym UM im. Karola Marcinkowskiego w Poznan i u Katedra Neonatologii, Poznan

85-168

S.U. nr2im. Dr. Jana Biziela Oddzial Kliniczny N. W. Z. Intensywna Terapia Noworodka wraz z Wgjazdowy m Zespolem N, Bydgoszcz

31-501

SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Neonatologii, Krakow

50-556

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

00-315

Szpital Kliniczny im. Ks, Anny Mazowieckiej Klinika Neonatologii, Warsaw

80-402

Uniwersyteckie Centrum Kliniczne, Gdansk

41-902

Szpital Spegialistycszny nr 2 w Bytomia Oddzial Noworodkow Blok V, Bytom

70-780

Samodzielny Publiczny Specjalistczny Zaklad Opieki Zdrowotnej Zdroje, Szczecin

93-338

Instytut Centrum Zdrowja Matki Polki Klinika Neonatologii, Lodz

Sponsors
All Listed Sponsors
lead

Windtree Therapeutics

INDUSTRY

NCT02636868 - The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age | Biotech Hunter | Biotech Hunter