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NCT03253263PHASE2Recruiting

A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

OHB Neonatology Ltd.

Start Date

5/9/2019

Completion Date

1/21/2028

Summary

The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: 1. Written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations). 2. Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations). 3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive. Exclusion Criteria: 1. Detectable major (or severe) congenital malformation identified before randomization. 2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion. 3. Hypoglycemia at Baseline (blood glucose less than (\<) 45 milligrams per deciliter \[mg/dL\] or 2.5 milli moles per liter \[mmol/L\]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism. 4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion. 5. Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results. 6. Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis). 7. The participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator. 8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy. 9. Birth mother with known HIV or hepatitis (B, C, or E) infection.

Interventions

DRUG

OHB-607

Interested in This Trial?

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Conditions

Bronchopulmonary DysplasiaChronic Lung Disease of PrematurityIntraventricular HemorrhageRetinopathy of Prematurity (ROP)

Locations

Arkansas Children's Hospital

Little Rock, Arkansas 72202-3500

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72202-3500

United States

Children's Hospital of Orange County

California City, California 92868

United States

LAC USC Medical Center

Los Angeles, California 90033-1804

United States

US Davis

Sacramento, California 95817

United States

Jackson Memorial Hospital

Miami, Florida 33136-1005

United States

Tampa General Hospital

Tampa, Florida 33606-3571

United States

University of Illinois at Chicago

Chicago, Illinois 60612

United States

Riley Hospital for Children

Indianapolis, Indiana 46202

United States

Memorial Hospital of South Bend

South Bend, Indiana 46601-1078

United States

Norton Children's Hospital

Louisville, Kentucky 40202

United States

Ochsner Baptist Medical Center

New Orleans, Louisiana 70115

United States

Tufts Medical Center

Boston, Massachusetts 02111-1553

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Children's Minnesota - Children's Hospital and Clinics - St. Paul

Saint Paul, Minnesota 55102

United States

Children's Minnesota - Children's Hospital and Clinics

Saint Paul, Minnesota 55102

United States

University of Mississippi Medical Center

Jackson, Mississippi 39216-4500

United States

University of Rochester

Rochester, New York 14627

United States

Maria Fareri Children's Hospital

Valhalla, New York 10595

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Medical University of South Carolina Children Hospital

Charleston, South Carolina 29425-8908

United States

Texas Children's Hospital

Houston, Texas 77030

United States

UT Health Science Center

San Antonio, Texas 78229

United States

UVA Children's Hospital

Charlottesville, Virginia 22903

United States

Virginia Commonwealth University - Children's Hospital of Richmond at VCU

Richmond, Virginia 23298-5075

United States

Royal Hospital for Women

Randwick, New South Wales 2031

Australia

Westmead Hospital

Westmead, New South Wales NSW 2145

Australia

Royal Women's Hospital

Parkville, 3052

Australia

Mater Misericordiae Limited

South Brisbane, Qld 4101

Australia

Sainte Justine Hospital

Montreal, Quebec

Canada

Mount Sinai Hospital

Toronto, M5G 1X5

Canada

Oulun Yliopistollinen Sairaala

Oulu, 90220

Finland

Hôpital Antoine Béclère

Clamart, Hauts-de-Seine 92140

France

Groupe Hospitalier Necker Enfants Malades

Paris, 75015

France

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg 79106

Germany

Universitatsklinikum Leipzig

Leipzig, Saxony 04103

Germany

Klinikum Nürnberg

Nuremberg, 90479

Germany

Cork University Maternity Hospital

Cork, Wilton T12YE02

Ireland

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio 00168

Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy 20122

Italy

Azienda Ospedaliera Di Padova

Padova, Veneto 35128

Italy

Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale

Florence, 50134

Italy

Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e

Genova, 16147

Italy

Presidio Ospedaliero Di Treviso Ca' Foncello

Treviso, 31100

Italy

Kagoshima City Hospital

Kagoshima, Kagoshima-ken 890-0055

Japan

Nagano Children's Hospital

Azumino, Nagano 399-8205

Japan

Kurashiki Central Hospital

Kurashiki-shi, Okayama-ken 710-0052

Japan

Saitama Medical Center

Kawagoe-shi, Saitama 350-8550

Japan

Saitama Prefectural Children's Medical Center

Saitama, Saitama 330-8777

Japan

Showa Medical University Hospital

Tokyo, 142-8666

Japan

National Center for Child Health and Development

Tokyo, 157-8535

Japan

Tokyo Metropolitan Children's Medical Center

Tokyo, 183-8561

Japan

Osaka Women's and Children's Hospital

Izumi, Ôsaka 594-1101

Japan

Maastricht University Medical Center

Maastricht, Limburg 6229 HX

Netherlands

Academisch Medisch Centrum Amsterdam

Amsterdam-Zuidoost, North Holland 1105 AZ

Netherlands

Wilhelmina Children Hospital-University Medical Center Utrecht

Utrecht, 3584 EA

Netherlands

Hospital Garcia de Orta

Almada, 2801-951

Portugal

Maternidade Alfredo da Costa

Lisbon, 1069-089

Portugal

Centro Hospitalar Lisboa

Lisbon, 1649-035

Portugal

Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E.

Porto, 4050-651

Portugal

Hospital General Universitario Dr. Balmis

Alicante, 03010

Spain

Skanes Universitetssjukhus

Lund, SE-22185

Sweden

Karolinska Solna

Stockholm, 171 76

Sweden

Norfolk and Norwich University Hospital

Norwich, Norfolk NR4 7UY

United Kingdom

Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital

Chertsey, Surrey KT16 0PZ

United Kingdom

University of Cambridge

Cambridge, CB2 0QQ

United Kingdom

University Hospital Coventry

Coventry, CV2 2DX

United Kingdom

Liverpool Women's Hospital - PPDS

Liverpool, L69 3BX

United Kingdom

University College London

London, NW1 2BU

United Kingdom

Chelsea and Westminster NHS Trust

London, SW3 6JJ

United Kingdom

St. Mary's Hospital

Manchester, M13 9WL

United Kingdom