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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
OHB Neonatology Ltd.
Study ID
NCT03253263
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Bronchopulmonary Dysplasia
  • Chronic Lung Disease of Prematurity
  • Intraventricular Hemorrhage
  • Retinopathy of Prematurity (ROP)

Eligibility Criteria

Sex
ALL
Age
0 Hours - 24 Hours
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 9, 2019
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Jan 21, 2028

Study Design

Enrollment
338 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: OHB-607
    Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
  • No Intervention: Standard Neonatal Care
    Standard neonatal care alone will be provided.

Primary Outcome Measure

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. [ Time Frame: Baseline through 36 weeks postmenstrual age (PMA) ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
Arkansas Children's HospitalLittle RockArkansas72202-3500-
University of Arkansas for Medical SciencesLittle RockArkansas72202-3500-
Children's Hospital of Orange CountyCalifornia CityCalifornia92868-
LAC USC Medical CenterLos AngelesCalifornia90033-1804-
US DavisSacramentoCalifornia95817-
Jackson Memorial HospitalMiamiFlorida33136-1005-
Tampa General HospitalTampaFlorida33606-3571-
University of Illinois at ChicagoChicagoIllinois60612-
Riley Hospital for ChildrenIndianapolisIndiana46202-
Memorial Hospital of South BendSouth BendIndiana46601-1078-
Norton Children's HospitalLouisvilleKentucky40202-
Ochsner Baptist Medical CenterNew OrleansLouisiana70115-
Boston Children's HospitalBostonMassachusetts02115-
Tufts Medical CenterBostonMassachusetts02111-1553-
Children's Minnesota - Children's Hospital and ClinicsSaint PaulMinnesota55102-
Children's Minnesota - Children's Hospital and Clinics - St. PaulSaint PaulMinnesota55102-
University of Mississippi Medical CenterJacksonMississippi39216-4500-
University of RochesterRochesterNew York14627-
Maria Fareri Children's HospitalValhallaNew York10595-
Nationwide Children's HospitalColumbusOhio43205-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Medical University of South Carolina Children HospitalCharlestonSouth Carolina29425-8908-
Texas Children's HospitalHoustonTexas77030-
UT Health Science CenterSan AntonioTexas78229-
UVA Children's HospitalCharlottesvilleVirginia22903-
Virginia Commonwealth University - Children's Hospital of Richmond at VCURichmondVirginia23298-5075-

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Hospital· Little Rock, ARUniversity of Arkansas for Medical Sciences· Little Rock, ARChildren's Hospital of Orange County· California City, CALAC USC Medical Center· Los Angeles, CAUS Davis· Sacramento, CAJackson Memorial Hospital· Miami, FL

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