A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
- Conditions
- Intraventricular HemorrhageRetinopathy of Prematurity (ROP)Bronchopulmonary DysplasiaChronic Lung Disease of Prematurity
- Interventions
- Registration Number
- NCT03253263
- Lead Sponsor
- OHB Neonatology Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 338
- 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).
- 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).
- Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.
- Detectable major (or severe) congenital malformation identified before randomization.
- Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
- 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.
- Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
- 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.
- 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).
- 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.
- Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OHB-607 OHB-607 Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
- Primary Outcome Measures
Name Time Method Reduction in the incidence of severe Bronchopulmonary Dysplasia (BPD) at 36 weeks (±3 days) Postmenstrual Age (PMA), or death at or before 36 weeks PMA, whichever comes first as compared to the SNC group. Baseline through 36 weeks postmenstrual age (PMA) Severe BPD is defined by the modified NICHD severity grading
- Secondary Outcome Measures
Name Time Method Chronic respiratory morbidity outcomes at 24 months CA 24 months CA Incidence and severity of BPD Baseline through 36 weeks postmenstrual age (PMA) BPD severity is defined by the modified NICHD severity grading
Neurodevelopment outcomes From 6 months CA through 24 months CA Neurodevelopmental impairment, Physical and cognitive development will be measured by ASQ®-3 administered at 12 and 24 months CA.
To assess the effect of OHB-607 on chronic respiratory outcomes as measured by the Chronic Lung Disease Prematurity Severity Score (CLDPSS) as compared to the SNC group at 12 months CA. Baseline until 12 months CA using CLDPSS Incidence and severity of IVH Baseline through 36 weeks postmenstrual age (PMA) Incidence of all grades of IVH as assessed by centrally read CUS and classified according to the Volpe criteria
Mortality from randomization through to 24 months CA From birth through 24 months CA Mortality rates from randomization to initial hospital discharge and from initial discharge through 24 months CA.
Jensen BPD grade at 36 weeks PMA (± 3 days), as classified according to Jensen et al., 2019. Incidence of all severity grades of BPD as assessed by Jensen et al., 2019 36 weeks weeks postmenstrual age (PMA) (± 3 days) Exposure-response relationship between measured IGF-1 and Retinopathy of Prematurity (ROP) Baseline through 40 weeks PMA Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of ROP
Incidence of Retinopathy of Prematurity (ROP) Baseline through 40 weeks PMA ROP is classified according to the International Classification
Reducing the burden of Chronic Lung Disease, as indicated by a reduction in time to final weaning off of Respiratory Technology Support (RTS) through 12 months Corrected Age (CA), as compared to the SNC group. Baseline through 12 months CA The final weaning off of RTS is defined as the 7th consecutive day that the subject is off RTS.
Reduction in the incidence of severe BPD at 36 weeks (±3 days) PMA, or death at or before 36 weeks PMA, whichever comes first as compared to the SNC group. Time Frame: Baseline through 36 weeks postmenstrual age (PMA) Severe BPD is defined based on the classification according to Jensen et al., 2019
Occurrence of severe (Grade 3 and 4) intraventricular hemorrhage (IVH) before 40 weeks PMA, as assessed by cranial ultrasound as compared to the SNC group Baseline through 40 weeks postmenstrual age (PMA) Severe IVH as classified according to the Volpe criteria
To assess the effect of OHB-607 on occurrence of severe retinopathy of prematurity (ROP) (Stage 3 and above) up to 40 weeks PMA as compared to the SNC group Baseline through 40 weeks postmenstrual age (PMA) The effect of OHB-607 on neurodevelopment is measured by the Cognitive, Language and Motor Scales of the Bayley Scales of Infant and Toddler Development (BSID) III as compared to the SNC group at 24 months CA. Time Frame: Determined by the separate BSID III scales at 24 months CA Exposure-response relationship between measured IGF-1 and Bronchopulmonary Dysplasia (BPD) Baseline through 36 weeks PMA Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of BPD
Exposure-response relationship between measured IGF-1 and intraventricular hemorrhage (IVH) Baseline through 40 weeks PMA Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of IVH
Exposure-response relationship between measured IGF-1 and necrotizing enterocolitis (NEC) Baseline through 40 weeks PMA Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of NEC
To assess the safety profile of OHB-607 as compared to the SNC group. Baseline through 24 months CA Incidence, severity, and causality assessment of Adverse Events (AEs) and Serious Adverse Events (SAEs), including Fatal AEs as per the neonatal adverse event severity scale.
Trial Locations
- Locations (61)
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
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, Baden-Württemberg, Germany
Universitatsklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Klinikum Nürnberg
🇩🇪Nürnberg, Germany
Cork University Maternity Hospital
🇮🇪Cork, Wilton, Ireland
Fondazione Policlinico Universitario A Gemelli
🇮🇹Roma, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliera Di Padova
🇮🇹Padova, Veneto, Italy
Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale
🇮🇹Firenze, Italy
Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e
🇮🇹Genova, Italy
Presidio Ospedaliero Di Treviso Ca' Foncello
🇮🇹Treviso, Italy
Kagoshima City Hospital
🇯🇵Kagoshima-shi, Kagosima, Japan
Nagano Children's Hospital
🇯🇵Azumino, Nagano, Japan
Kurashiki Central Hospital
🇯🇵Kurashiki-shi, Okayama, Japan
Saitama Medical Center
🇯🇵Kawagoe-shi, Saitama, Japan
Osaka Women's and Children's Hospital
🇯🇵Izumi, Ôsaka, Japan
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands
Academisch Medisch Centrum Amsterdam
🇳🇱Amsterdam-Zuidoost, Noord-Holland, Netherlands
Wilhelmina Children Hospital-University Medical Center Utrecht
🇳🇱Utrecht, Netherlands
Hospital Garcia de Orta
🇵🇹Almada, Portugal
Maternidade Alfredo da Costa
🇵🇹Lisboa, Portugal
Centro Hospitalar Lisboa
🇵🇹Lisboa, 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