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Clinical Trials in the UK / NCT03253263
Active, not recruiting Phase 2

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

NCT03253263 · tracked via the Priya Life Science UK tracker
Sponsor
OHB Neonatology Ltd.
Phase
Phase 2
Started
2019-05-09
Last updated
2026-08-03

Condition(s) studied

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

Investigational drug(s) / intervention(s)

OHB-607

OHB-607: Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days.

Study 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

Sex
ALL
Min age
0 Hours
Max age
24 Hours
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (62)

FacilityCityRegionStatus
Arkansas Children's Hospital Little Rock Arkansas
University of Arkansas for Medical Sciences Little Rock Arkansas
Children's Hospital of Orange County California City California
Cedars Sinai Medical Center Los Angeles California
US Davis Sacramento California
Jackson Memorial Hospital Miami Florida
Tampa General Hospital Tampa Florida
University of Illinois at Chicago Chicago Illinois
Riley Hospital for Children Indianapolis Indiana
Memorial Hospital of South Bend South Bend Indiana
University of Louisville Hospital Louisville Kentucky
Ochsner Baptist Medical Center New Orleans Louisiana
Tufts Medical Center Boston Massachusetts
Children's Minnesota - Children's Hospital and Clinics - St. Paul Saint Paul Minnesota
Children's Minnesota - Children's Hospital and Clinics Saint Paul Minnesota
University of Mississippi Medical Center Jackson Mississippi
University of Rochester Rochester New York
Maria Fareri Children's Hospital Valhalla New York
Oklahoma Children's Hospital - PIN Oklahoma City Oklahoma
Medical University of South Carolina Children Hospital Charleston South Carolina
Texas Children's Hospital Houston Texas
UT Health Science Center San Antonio Texas
UVA Children's Hospital Charlottesville Virginia
Virginia Commonwealth University - Children's Hospital of Richmond at VCU Richmond Virginia
Royal Hospital for Women Randwick New South Wales
Westmead Hospital Westmead New South Wales
Royal Women's Hospital Parkville Australia
Mater Misericordiae Limited South Brisbane Australia
Sainte Justine Hospital Montreal Quebec
Oulun Yliopistollinen Sairaala Oulu Finland
Universitatsklinikum Leipzig Leipzig Saxony
Klinikum Nürnberg Nuremberg Germany
Cork University Maternity Hospital Cork Wilton
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan Lombardy
Azienda Ospedaliera Di Padova Padova Veneto
Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale Florence Italy
Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e Genova Italy
Presidio Ospedaliero Di Treviso Ca' Foncello Treviso Italy
Nagano Children's Hospital Azumino Nagano
Kurashiki Central Hospital Kurashiki-shi Okayama-ken

+ 22 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03253263 on ClinicalTrials.gov ↗ ← All trials in the UK