BridgeMD
A study evaluating the safety and efficacy of an experimental drug for chronic lung disease against normally prescribed care in extremely premature babies
EU CTIS ID: 2024-515914-41-00
What this study is testing
To assess the effect of OHB-607 on reducing the burden of CLD, as indicated by a reduction in the incidence of severe BPD (as defined by the modified NICHD severity grading) at 36 weeks (±3 days) PMA, or death at or before 36 weeks PMA, whichever comes first as compared to the SNC group.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consents and/or assents must be signed and dated by the subject's parent(s) prior to any study-related procedures. The informed consent and any assents for underage parents must be approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) (in accordance with local regulations).
- Written informed consents and/or assents must be signed and dated by the subject's birth mother prior to providing study-related information related to birth mother medical history, pregnancy, and the birth of the subject. 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.
You likely can't join if
- Detectable major (or severe) congenital malformation identified before randomization.
- Birth mother with active coronavirus disease 2019 (COVID-19) infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
- Major (or severe) congenital malformations include structurally significant congenital heart disease and structural abnormalities of the upper airway, lungs, or chest wall. Congenital malformations that are suspected of being associated with chromosomal abnormalities, genetic syndromes, and neoplasia should be excluded, as well as abnormalities that may affect life expectancy, cardiopulmonary development, neurologic development, or interpretation of study results.
- Birth mother with known HIV or hepatitis (B, C, or E) infection.
- Isolated minor dysmorphic anomalies that are unlikely to be exclusionary could include post-axial polydactyly, ankyloglossia, accessory nipples, preauricular pits, single or horizontal palmar crease, clinodactyly, and single umbilical artery. However, the presence of multiple minor anomalies in the same infant may be exclusionary.
- Uncomplicated infantile hemangiomas are unlikely to be exclusionary. However, subjects with infantile hemangiomas that may be associated with potential for disfigurement, life-threatening complications, functional impairment, ulceration, or underlying abnormalities should be excluded.
See the full eligibility criteria
Who can join
- Written informed consents and/or assents must be signed and dated by the subject's parent(s) prior to any study-related procedures. The informed consent and any assents for underage parents must be approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) (in accordance with local regulations).
- Written informed consents and/or assents must be signed and dated by the subject's birth mother prior to providing study-related information related to birth mother medical history, pregnancy, and the birth of the subject. 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.
What rules you out
- Detectable major (or severe) congenital malformation identified before randomization.
- Birth mother with active coronavirus disease 2019 (COVID-19) infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
- Major (or severe) congenital malformations include structurally significant congenital heart disease and structural abnormalities of the upper airway, lungs, or chest wall. Congenital malformations that are suspected of being associated with chromosomal abnormalities, genetic syndromes, and neoplasia should be excluded, as well as abnormalities that may affect life expectancy, cardiopulmonary development, neurologic development, or interpretation of study results.
- Birth mother with known HIV or hepatitis (B, C, or E) infection.
- Isolated minor dysmorphic anomalies that are unlikely to be exclusionary could include post-axial polydactyly, ankyloglossia, accessory nipples, preauricular pits, single or horizontal palmar crease, clinodactyly, and single umbilical artery. However, the presence of multiple minor anomalies in the same infant may be exclusionary.
- Uncomplicated infantile hemangiomas are unlikely to be exclusionary. However, subjects with infantile hemangiomas that may be associated with potential for disfigurement, life-threatening complications, functional impairment, ulceration, or underlying abnormalities should be excluded.
- Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator’s opinion.
- Hypoglycemia at baseline (blood glucose <45 mg/dL or 2.5 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 (CUS) (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 subject or interfere with the subject’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 subject or subject’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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- Australia
- Japan
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; Australia; Japan; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.