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Tests treatment safety and results for Intraventricular Hemorrhage of Prematurity
Official title Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage
ClinicalTrials.gov ID: NCT05617833
What this study is testing
What is MLT+EPO?
MLT+EPO is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for intraventricular hemorrhage of prematurity.
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
- Very preterm infants are prone to numerous medical complications with lifelong impact. Amongst the most serious neurologically are white matter injury (WMI), intraventricular hemorrhage (IVH) and the subsequent progression to posthemorrhagic hydrocephalus (PHH).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 2
You may be able to join if
- Neonatal intensive care unit (NICU) inpatients born at \>22 and \<32 weeks gestation (born after 22w-6/7 and before or on 31-6/7 week GA)
- IVH or moderate/severe white matter injury within the first 21 days from birth
- Infants born prior to 30 weeks GA may enroll until DOL 30. Infants born after 30 weeks may enroll until DOL 21. Treatment must be started by 33+0.
- Approval of the primary neonatologist
- Appropriate caregiver to provide informed consent
You likely can't join if
- (below). Exclusion Criteria:
- Participation in another pharmacological intervention trial that involves multiple doses of a medication that may interact with EPO+MLT. Examples of...
- Is on jet ventilator or has not been off jet ventilator for at least 72 hours
- Has been diagnosed with or is suspected of having a congenital anomaly or genetic disorder associated with brain malformation or life expectancy \<40...
- Is within 3 days of starting treatment for a severe clinical condition which is potentially associated with a life expectancy \<3 days. These include...
- Other clinical conditions including: Hydrops fetalis Hypertension for age requiring sustained medication Polycythemia (hematocrit \>65%) \- No...
See the full eligibility criteria
- Neonatal intensive care unit (NICU) inpatients born at \>22 and \<32 weeks gestation (born after 22w-6/7 and before or on 31-6/7 week GA)
- IVH or moderate/severe white matter injury within the first 21 days from birth
- Infants born prior to 30 weeks GA may enroll until DOL 30. Infants born after 30 weeks may enroll until DOL 21. Treatment must be started by 33+0.
- Approval of the primary neonatologist
- Appropriate caregiver to provide informed consent
- Is not known to meet or suspected of meeting any of the
- (below). Exclusion Criteria:
- Participation in another pharmacological intervention trial that involves multiple doses of a medication that may interact with EPO+MLT. Examples of exemptions would include single dose administration for...
- Is on jet ventilator or has not been off jet ventilator for at least 72 hours
- Has been diagnosed with or is suspected of having a congenital anomaly or genetic disorder associated with brain malformation or life expectancy \<40 weeks post menstrual age (PMA). These include but are not limited to...
- Is within 3 days of starting treatment for a severe clinical condition which is potentially associated with a life expectancy \<3 days. These include but are not limited to disseminated intravascular coagulation...
- Other clinical conditions including: Hydrops fetalis Hypertension for age requiring sustained medication Polycythemia (hematocrit \>65%) \- No caregiver to provide consent The clinical condition of potential candidates...
The study team makes the final eligibility decision.
Where it's taking place
- St. Petersburg, Florida, United States
- Baltimore, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 12 hours to 2 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St. Petersburg, Florida, United States; Baltimore, Maryland, 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 ClinicalTrials.gov; the study team decides eligibility.