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Tests treatment safety and results for Bronchopulmonary Dysplasia
Official title A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
ClinicalTrials.gov ID: NCT03253263
What this study is testing
What is OHB-607?
OHB-607 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bronchopulmonary dysplasia.
Also referred to as Mecasermin Rinfabate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 24
You may be able to join if
- 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...
- Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information...
- people 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.
- 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...
- Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal...
- 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...
- Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-treatment...
See the full eligibility criteria
- 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...
- 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...
- people must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.
- 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...
- 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...
- Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- California City, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- South Bend, Indiana, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Saint Paul, Minnesota, United States
- Jackson, Mississippi, United States
- Rochester, New York, United States
- Valhalla, New York, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Charleston, South Carolina, United States
- Houston, Texas, United States
+ 45 more site(s).
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 hours to 24 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; California City, California, United States; Los Angeles, California, United States; Sacramento, California, United States; Miami, Florida, United States; Tampa, Florida, United States and 59 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.