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Safety of Melatonin and Erythropoietin for Preterm Infants with Brain Bleeding

This study is looking at the safety of combining two treatments, melatonin (MLT) and erythropoietin (EPO), for very preterm infants who have experienced intraventricular hemorrhage (IVH), which is bleeding in the brain. This bleeding can sometimes lead to other serious brain issues. The study aims to find a safe dose of MLT and EPO together. Infants born between 22 and 32 weeks of pregnancy who have IVH or moderate/severe white matter injury (WMI) within the first 21 days after birth may be able to join. The main goal is to track any serious side effects or deaths up to 4 weeks after treatment ends. The current recruitment status is unclear.

Study design
This is a randomized, double-blind study involving about 60 participants. It is a Phase I trial, meaning it's focused on safety.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety outcomes up to 4 weeks after treatment concludes, or until 38 weeks gestational age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05617833

Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage

Recruiting
PHASE1Ages 12–2InterventionalTreatment
Johns Hopkins University
~60 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:MLT+EPOPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of SAE/DLT including death
Measured over 4 weeks after the conclusion of treatment, up to 38 weeks gestational age

Conditions

Intraventricular Hemorrhage of Prematurity

Explore related trials

Intraventricular Brain HemorrhageWhite Matter Injury

Where it's being run

2 sites across 2 states
Florida1
Maryland1

Study leadership

  • Shenandoah Robinson, MD · STUDY_CHAIR · Johns Hopkins University

Who to contact

Kathryn Lowe
[email protected]
443-721-4390
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.
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 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.
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
Other clinical conditions including:

What this trial measures

  • Rate of SAE/DLT including death4 weeks after the conclusion of treatment, up to 38 weeks gestational age

    to test the hypothesis that rate of Serious Adverse Events (SAE)/dose limiting toxicity (DLT) with a cocktail of MLT and EPO in very preterm infants with severe intraventricular hemorrhage (sIVH) will have similar rate of SAE/DLT in subjects treated with placebo