What side effects are associated with this type of intervention?

Melatonin and erythropoietin (EPO) are being studied for their potential to prevent the progression of severe intraventricular hemorrhage (sIVH) to posthemorrhagic hydrocephalus (PHH) in very preterm infants. The primary endpoint of the trial is to assess the safety of these treatments, specifically looking at serious adverse events (SAE) and dose-limiting toxicities (DLT). While the trial aims to establish the safety profile, common side effects of EPO in other contexts include hypertension, thromboembolism, and potential for increased tumor growth. Melatonin is generally well-tolerated, but larger studies are needed to confirm its long-term safety in this specific population.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for intraventricular hemorrhage (IVH) that focus on the neuroprotective and anti-inflammatory effects similar to melatonin and erythropoietin. Current management of IVH primarily involves supportive care and surgical interventions, such as shunt placement for posthemorrhagic hydrocephalus. The trial mentioned is exploring the potential of melatonin and erythropoietin to prevent progression from early postnatal IVH to subsequent hydrocephalus, but these treatments are not yet FDA-approved for this indication.

What other types of research exist?

Promising novel alternatives to Melatonin and Erythropoietin for intraventricular hemorrhage patients include: 1) Minocycline, an antibiotic with anti-inflammatory and neuroprotective properties; 2) N-acetylcysteine (NAC), an antioxidant that reduces oxidative stress and inflammation; 3) Magnesium sulfate, which has neuroprotective effects by stabilizing cellular membranes and reducing excitotoxicity; and 4) Stem cell therapy, which has shown potential in promoting repair and reducing inflammation in brain injuries.

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Hormone Therapy

Melatonin + Erythropoietin for Intraventricular Hemorrhage (SCEMPI Trial)

Q: What is the mechanism of action of this treatment?

Melatonin and erythropoietin are being studied for their potential benefits in treating intraventricular hemorrhage (IVH) due to their neuroprotective and anti-inflammatory properties. Melatonin helps reduce oxidative stress and inflammation, which can protect brain cells from damage. Erythropoietin promotes cell survival, reduces apoptosis (cell death), and also has anti-inflammatory effects. These mechanisms are important for IVH patients as they aim to prevent the progression of brain injury and reduce the risk of developing posthemorrhagic hydrocephalus, thereby potentially improving long-term neurological outcomes.

Phase 1

Recruiting

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

sIVH within the first 21 days from birth, defined as at least unilateral grade III5 on head ultrasound performed within the past 5 days

Neonatal Intensive Care Unit (NICU) inpatients born at >22 and <32 wks gestation (born after 22w6d and before or on 31-6/7 wk GA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after the conclusion of treatment, up to 38 weeks gestational age

Summary

This trial is testing melatonin and erythropoietin in very premature babies with severe brain bleeding. The goal is to see if these substances can protect the brain and prevent a condition that currently requires surgery. If successful, this could reduce lifelong complications for these infants. Erythropoietin has been shown to have protective effects on the brain and is often used in premature infants.

Who is the study for?

This trial is for very preterm infants born between 22+6/7 and 31+6/7 weeks of gestation, who have severe intraventricular hemorrhage (sIVH) diagnosed within the first 21 days. They must be expected to survive at least three more days, not have a life-threatening congenital anomaly or disorder, and have a caregiver able to consent.

What is being tested?

The trial tests if melatonin (MLT) combined with erythropoietin (EPO) can safely prevent progression from sIVH to posthemorrhagic hydrocephalus in preterm infants. It's a randomized, double-blind study comparing MLT+EPO against placebo, alongside standard care.

What are the potential side effects?

Potential side effects are not explicitly listed but will be monitored as any serious adverse event or dose limiting toxicity that may arise during treatment with MLT and EPO compared to placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby had a severe brain bleed within 21 days after birth.

Select...

My baby was born between 23 and 32 weeks of pregnancy and is in the NICU.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks after the conclusion of treatment, up to 38 weeks gestational age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks after the conclusion of treatment, up to 38 weeks gestational age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after the conclusion of treatment, up to 38 weeks gestational age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of SAE/DLT including death

Secondary study objectives

Efficacy of EPO plus MLT as assessed by rate of preterm birth related co-morbidities

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MLT+EPOExperimental Treatment1 Intervention

Melatonin 3 mg/mL oral syringe enterally every evening. For neonates weighing less than 1200 g, divide the dose in half and administer each half 30 minutes apart. High dose epoetin alfa epbx recombinant (1000 units/kg) syringe IV every 48 hours for 10 doses. Low dose epoetin alfa-epbx recombinant (400 units/kg) subcutaneously or intravenously three times weekly on Monday, Wednesday, and Friday until age 33-6/7wk.

Group II: PlaceboPlacebo Group1 Intervention

Placebo oral syringe enterally every evening. Placebo syringe IV every 48 hours for 10 doses. Placebo subcutaneously or intravenously three times weekly on Monday, Wednesday, and Friday until age 33-6/7wk.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Melatonin and erythropoietin are being studied for their potential benefits in treating intraventricular hemorrhage (IVH) due to their neuroprotective and anti-inflammatory properties. Melatonin helps reduce oxidative stress and inflammation, which can protect brain cells from damage. Erythropoietin promotes cell survival, reduces apoptosis (cell death), and also has anti-inflammatory effects. These mechanisms are important for IVH patients as they aim to prevent the progression of brain injury and reduce the risk of developing posthemorrhagic hydrocephalus, thereby potentially improving long-term neurological outcomes.