Testing Erythropoietin and Melatonin for Very Preterm Infants with Brain Bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion 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 exclusion criteria (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 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:

Hydrops fetalis Hypertension for age requiring sustained medication Polycythemia (hematocrit \>65%)

\- 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 it's running

• Johns Hopkins All Children's Hospital
  St. Petersburg, Florida, United States Recruiting
• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Kathryn Lowe
• Email: kathrynlowe@jhmi.edu
• Phone: 443-721-4390

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.