A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
NCT ID: NCT03253263
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
338 participants
INTERVENTIONAL
2019-05-09
2028-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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OHB-607
Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
OHB-607
Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days.
Standard Neonatal Care
Standard neonatal care alone will be provided.
No interventions assigned to this group
Interventions
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OHB-607
Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
0 Hours
24 Hours
ALL
No
Sponsors
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OHB Neonatology Ltd.
INDUSTRY
Responsible Party
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Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Children's Hospital of Orange County
California City, California, United States
LAC USC Medical Center
Los Angeles, California, United States
Jackson Memorial Hospital
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Minnesota - Children's Hospital and Clinics - St. Paul
Saint Paul, Minnesota, United States
Children's Minnesota - Children's Hospital and Clinics
Saint Paul, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Rochester
Rochester, New York, United States
Maria Fareri Children's Hospital
Valhalla, New York, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Medical University of South Carolina Children Hospital
Charleston, South Carolina, United States
UVA Children's Hospital
Charlottesville, Virginia, United States
Virginia Commonwealth University - Children's Hospital of Richmond at VCU
Richmond, Virginia, United States
Royal Hospital for Women
Randwick, New South Wales, Australia
Royal Women's Hospital
Parkville, , Australia
Mater Misericordiae Limited
South Brisbane, , Australia
Sainte Justine Hospital
Montreal, Quebec, Canada
Mount Sinai Hospital
Toronto, , Canada
Oulun Yliopistollinen Sairaala
Oulu, , Finland
Hôpital Antoine Béclère
Clamart, Hauts-de-Seine, France
Groupe Hospitalier Necker Enfants Malades
Paris, , France
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, Germany
Klinikum Nürnberg
Nuremberg, , Germany
Cork University Maternity Hospital
Cork, Wilton, Ireland
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Azienda Ospedaliera Di Padova
Padua, Veneto, Italy
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
Kagoshima City Hospital
Kagoshima, Kagoshima-ken, Japan
Nagano Children's Hospital
Azumino, Nagano, Japan
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken, Japan
Saitama Medical Center
Kawagoe-shi, Saitama, Japan
Showa Medical University Hospital
Tokyo, , Japan
Tokyo Metropolitan Children's Medical Center
Tokyo, , Japan
Osaka Women's and Children's Hospital
Izumi, Ôsaka, Japan
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Academisch Medisch Centrum Amsterdam
Amsterdam-Zuidoost, North Holland, Netherlands
Wilhelmina Children Hospital-University Medical Center Utrecht
Utrecht, , Netherlands
Hospital Garcia de Orta
Almada, , Portugal
Maternidade Alfredo da Costa
Lisbon, , Portugal
Centro Hospitalar Lisboa
Lisbon, , Portugal
Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E.
Porto, , Portugal
Hospital General Universitario Dr. Balmis
Alicante, , Spain
Skanes Universitetssjukhus
Lund, , Sweden
Karolinska Solna
Stockholm, , Sweden
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital
Chertsey, Surrey, United Kingdom
University of Cambridge
Cambridge, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Liverpool Women's Hospital - PPDS
Liverpool, , United Kingdom
University College London
London, , United Kingdom
Chelsea and Westminster NHS Trust
London, , United Kingdom
St. Mary's Hospital
Manchester, , United Kingdom
Countries
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Central Contacts
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References
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Kramer BW, Abman S, Daly M, Jobe AH, Niklas V. Insulin-like growth factor-1 replacement therapy after extremely premature birth: An opportunity to optimize lifelong lung health by preserving the natural sequence of lung development. Paediatr Respir Rev. 2023 Dec;48:24-29. doi: 10.1016/j.prrv.2023.05.001. Epub 2023 May 6.
Ley D, Hallberg B, Hansen-Pupp I, Dani C, Ramenghi LA, Marlow N, Beardsall K, Bhatti F, Dunger D, Higginson JD, Mahaveer A, Mezu-Ndubuisi OJ, Reynolds P, Giannantonio C, van Weissenbruch M, Barton N, Tocoian A, Hamdani M, Jochim E, Mangili A, Chung JK, Turner MA, Smith LEH, Hellstrom A; study team. rhIGF-1/rhIGFBP-3 in Preterm Infants: A Phase 2 Randomized Controlled Trial. J Pediatr. 2019 Mar;206:56-65.e8. doi: 10.1016/j.jpeds.2018.10.033. Epub 2018 Nov 22.
Hellstrom W, Hortensius LM, Lofqvist C, Hellgren G, Tataranno ML, Ley D, Benders MJNL, Hellstrom A, Bjorkman-Burtscher IM, Heckemann RA, Savman K. Postnatal serum IGF-1 levels associate with brain volumes at term in extremely preterm infants. Pediatr Res. 2023 Feb;93(3):666-674. doi: 10.1038/s41390-022-02134-4. Epub 2022 Jun 9.
Other Identifiers
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2018-001393-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
jRCT2071200076
Identifier Type: REGISTRY
Identifier Source: secondary_id
OHB-607-202
Identifier Type: -
Identifier Source: org_study_id
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