Testing Erythropoietin and Melatonin for Very Preterm Infants with Brain Bleeding
Safety of Combined Therapy With Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage (SCEMPI)
PHASE1 · Johns Hopkins University · NCT05617833
This study is testing if a combination of two medications, erythropoietin and melatonin, can safely help very preterm infants with serious brain bleeding to prevent further complications.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Hours to 2 Months |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05617833 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety of combining erythropoietin (EPO) and melatonin (MLT) in very preterm infants who have experienced significant intraventricular hemorrhage (sIVH). The study will enroll up to 60 neonates born between 22 and 32 weeks of gestation, who will be randomized to receive either the combination treatment or a placebo, alongside standard care. The primary goal is to determine a safe dosage of EPO and MLT to prevent the progression of sIVH to posthemorrhagic hydrocephalus (PHH), a serious condition requiring surgical intervention. Participants will be monitored from treatment initiation until they reach 37 weeks of gestational age.
Who should consider this trial
Good fit: Ideal candidates for this study are very preterm infants born between 22 and 32 weeks of gestation who have been diagnosed with significant intraventricular hemorrhage.
Not a fit: Patients who are on a jet ventilator or have congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of long-term complications associated with brain bleeding in very preterm infants.
How similar studies have performed: While the combination of EPO and MLT is being explored in this context, similar approaches have shown promise in preclinical studies, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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) 2. sIVH within the first 21 days from birth, defined as at least unilateral grade II on head ultrasound (HUS) performed within 18 days of enrollment 3. Approval of the primary neonatologist 4. Appropriate caregiver to provide informed consent 5. Is not known to meet or suspected of meeting any of the exclusion criteria (below). Exclusion Criteria: 1. 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 pharmacokinetic studies of an antibiotic, a single or few doses of a new surfactant, or a single intervention to reduce pain. 2. Is on jet ventilator or has not been off jet ventilator for at least 72 hours 3. 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 TORCH infections associated with radiographic evidence of substantial brain injury, trisomy 13, coarctation of the aorta, and severe liver failure. TORCH infections not associated with radiographic evidence of brain malformation or treatment for presumed TORCH infection are not exclusionary. 4. 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 (DIC)/severe hematologic crisis, severe sepsis, Hypoxic-ischemic encephalopathy (HIE), severe brain injury 5. Other clinical conditions including: Hydrops fetalis Hypertension for age requiring sustained medication Polycythemia (hematocrit \>65%) 6. No caregiver to provide consent The clinical condition of potential candidates will be monitored throughout the eligibility period to ensure the participant's continued candidacy for participating in the trial.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Study coordinator: Kathryn Lowe
- Email: kathrynlowe@jhmi.edu
- Phone: 443-721-4390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intraventricular Hemorrhage of Prematurity, SCEMPI, Erythropoietin, Melatonin, preterm infants, Intraventricular Hemorrhage