Status:
RECRUITING
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
Lead Sponsor:
OHB Neonatology Ltd.
Conditions:
Bronchopulmonary Dysplasia
Chronic Lung Disease of Prematurity
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Birth mother with known HIV or hepatitis (B, C, or E) infection.
Key Trial Info
Start Date :
May 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 21 2028
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT03253263
Start Date
May 9 2019
End Date
January 21 2028
Last Update
January 7 2026
Active Locations (66)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3500
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202-3500
3
Children's Hospital of Orange County
California City, California, United States, 92868
4
LAC USC Medical Center
Los Angeles, California, United States, 90033-1804