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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 0 Hours and 24 Hours
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

Arkansas Children's Hospital
Little Rock 4119403, Arkansas 4099753 72202-3500

University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72202-3500

Children's Hospital of Orange County
California City 5332748, California 5332921 92868

Jackson Memorial Hospital
Miami 4164138, Florida 4155751 33136-1005

Tampa General Hospital
Tampa 4174757, Florida 4155751 33606-3571

University of Illinois at Chicago
Chicago 4887398, Illinois 4896861 60612

Riley Hospital for Children
Indianapolis 4259418, Indiana 4921868 46202

Memorial Hospital of South Bend
South Bend 4926563, Indiana 4921868 46601-1078

Norton Children's Hospital
Louisville 4299276, Kentucky 6254925 40202

Ochsner Baptist Medical Center
New Orleans 4335045, Louisiana 4331987 70115

Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111-1553

Children's Minnesota - Children's Hospital and Clinics - St. Paul
Saint Paul 5045360, Minnesota 5037779 55102

Children's Minnesota - Children's Hospital and Clinics
Saint Paul 5045360, Minnesota 5037779 55102

University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216-4500

University of Rochester
Rochester 5134086, New York 5128638 14627

Maria Fareri Children's Hospital
Valhalla 5142090, New York 5128638 10595

University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104

Medical University of South Carolina Children Hospital
Charleston 4574324, South Carolina 4597040 29425-8908

UVA Children's Hospital
Charlottesville 4752031, Virginia 6254928 22903

Virginia Commonwealth University - Children's Hospital of Richmond at VCU
Richmond 4781708, Virginia 6254928 23298-5075

More Details

NCT ID
NCT03253263
Status
Recruiting
Sponsor
OHB Neonatology Ltd.

Study Contact

OHB Contact
CMO@Oakhillbio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.