Actively Recruiting
Led by OHB Neonatology Ltd. · Updated on 2026-01-07
338
Participants Needed
66
Research Sites
104 weeks
Total Duration
Researchers are evaluating an investigational drug called OHB-607 to prevent Bronchopulmonary Dysplasia (BPD), a common chronic lung disease in extremely premature infants. The study compares infants receiving OHB-607 to those receiving standard neonatal care to see if the drug can reduce the incidence of severe BPD or death by 36 weeks postmenstrual age. This is a Phase 2b, randomized, open-label study involving infants born between 23 weeks 0 days and 27 weeks 6 days gestational age. Participants in the trial will be randomly assigned to one of two groups. One group will receive a continuous intravenous infusion of OHB-607 from birth until 29 weeks and 6 days postmenstrual age. The other group will receive standard neonatal care without the investigational drug. This approach allows researchers to compare the effects of OHB-607 against routine care practices for preventing lung disease in these infants. During the study, infants will be closely monitored through 36 weeks postmenstrual age and up to 24 months corrected age. Researchers will assess lung health, including the incidence and severity of BPD, time to weaning off respiratory support, and other complications such as intraventricular hemorrhage and retinopathy of prematurity. Developmental outcomes will also be measured using standardized scales at 24 months corrected age. Safety assessments and long-term follow-up are included to understand the drug's effects over time.
CONDITIONS
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From birth up to postmenstrual age 29 weeks + 6 days
Participants receive continuous intravenous infusion of OHB-607 from birth up to postmenstrual age 29 weeks and 6 days, or receive standard neonatal care.
Ongoing hospital care visits during treatment period
Duration - Up to 24 months corrected age
Participants are monitored for safety, neurodevelopment, respiratory outcomes, and other health measures up to 24 months corrected age.
Regular follow-up visits up to 24 months corrected age
Total: 66 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3500
Actively Recruiting
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202-3500
Actively Recruiting
3
Children's Hospital of Orange County
California City, California, United States, 92868
Actively Recruiting
4
LAC USC Medical Center
Los Angeles, California, United States, 90033-1804
Active, Not Recruiting
5
Jackson Memorial Hospital
Miami, Florida, United States, 33136-1005
Actively Recruiting
6
Tampa General Hospital
Tampa, Florida, United States, 33606-3571
Actively Recruiting
7
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
8
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
9
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601-1078
Actively Recruiting
10
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
11
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States, 70115
Actively Recruiting
12
Tufts Medical Center
Boston, Massachusetts, United States, 02111-1553
Actively Recruiting
13
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Withdrawn
14
Children's Minnesota - Children's Hospital and Clinics - St. Paul
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
15
Children's Minnesota - Children's Hospital and Clinics
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
16
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4500
Actively Recruiting
17
University of Rochester
Rochester, New York, United States, 14627
Actively Recruiting
18
Maria Fareri Children's Hospital
Valhalla, New York, United States, 10595
Actively Recruiting
19
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Not Yet Recruiting
20
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
21
Medical University of South Carolina Children Hospital
Charleston, South Carolina, United States, 29425-8908
Actively Recruiting
22
UVA Children's Hospital
Charlottesville, Virginia, United States, 22903
Actively Recruiting
23
Virginia Commonwealth University - Children's Hospital of Richmond at VCU
Richmond, Virginia, United States, 23298-5075
Actively Recruiting
24
Royal Hospital for Women
Randwick, New South Wales, Australia, 2031
Actively Recruiting
25
Royal Women's Hospital
Parkville, Australia, 3052
Actively Recruiting
26
Mater Misericordiae Limited
South Brisbane, Australia, Qld 4101
Actively Recruiting
27
Sainte Justine Hospital
Montreal, Quebec, Canada
Actively Recruiting
28
Mount Sinai Hospital
Toronto, Canada, M5G 1X5
Withdrawn
29
Oulun Yliopistollinen Sairaala
Oulu, Finland, 90220
Actively Recruiting
30
Hôpital Antoine Béclère
Clamart, Hauts-de-Seine, France, 92140
Active, Not Recruiting
31
Groupe Hospitalier Necker Enfants Malades
Paris, France, 75015
Active, Not Recruiting
32
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Withdrawn
33
Universitatsklinikum Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
34
Klinikum Nürnberg
Nuremberg, Germany, 90479
Actively Recruiting
35
Cork University Maternity Hospital
Cork, Wilton, Ireland, T12YE02
Actively Recruiting
36
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, Italy, 00168
Actively Recruiting
37
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy, 20122
Actively Recruiting
38
Azienda Ospedaliera Di Padova
Padova, Veneto, Italy, 35128
Actively Recruiting
39
Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale
Florence, Italy, 50134
Actively Recruiting
40
Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e
Genova, Italy, 16147
Actively Recruiting
41
Presidio Ospedaliero Di Treviso Ca' Foncello
Treviso, Italy, 31100
Actively Recruiting
42
Kagoshima City Hospital
Kagoshima, Kagoshima-ken, Japan, 890-0055
Active, Not Recruiting
43
Nagano Children's Hospital
Azumino, Nagano, Japan, 399-8205
Actively Recruiting
44
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken, Japan, 710-0052
Actively Recruiting
45
Saitama Medical Center
Kawagoe-shi, Saitama, Japan, 350-8550
Actively Recruiting
46
Showa Medical University Hospital
Tokyo, Japan, 142-8666
Actively Recruiting
47
Tokyo Metropolitan Children's Medical Center
Tokyo, Japan, 183-8561
Actively Recruiting
48
Osaka Women's and Children's Hospital
Izumi, Ôsaka, Japan, 594-1101
Actively Recruiting
49
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX
Actively Recruiting
50
Academisch Medisch Centrum Amsterdam
Amsterdam-Zuidoost, North Holland, Netherlands, 1105 AZ
Actively Recruiting
51
Wilhelmina Children Hospital-University Medical Center Utrecht
Utrecht, Netherlands, 3584 EA
Actively Recruiting
52
Hospital Garcia de Orta
Almada, Portugal, 2801-951
Actively Recruiting
53
Maternidade Alfredo da Costa
Lisbon, Portugal, 1069-089
Actively Recruiting
54
Centro Hospitalar Lisboa
Lisbon, Portugal, 1649-035
Actively Recruiting
55
Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E.
Porto, Portugal, 4050-651
Actively Recruiting
56
Hospital General Universitario Dr. Balmis
Alicante, Spain, 03010
Actively Recruiting
57
Skanes Universitetssjukhus
Lund, Sweden, SE-22185
Completed
58
Karolinska Solna
Stockholm, Sweden, 171 76
Withdrawn
59
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
Actively Recruiting
60
Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital
Chertsey, Surrey, United Kingdom, KT16 0PZ
Completed
61
University of Cambridge
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
62
University Hospital Coventry
Coventry, United Kingdom, CV2 2DX
Actively Recruiting
63
Liverpool Women's Hospital - PPDS
Liverpool, United Kingdom, L69 3BX
Actively Recruiting
64
University College London
London, United Kingdom, NW1 2BU
Withdrawn
65
Chelsea and Westminster NHS Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
66
St. Mary's Hospital
Manchester, United Kingdom, M13 9WL
Actively Recruiting
O
OHB Contact
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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