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Hormone Therapy

MLT+EPO for Intraventricular Hemorrhage (SCEMPI Trial)

Q: What is the number of participants currently enrolled in this clinical study?

Indeed, the details on clinicaltrials.gov confirm that this research study is actively seeking participants. The trial was initially listed on January 16th, 2024 and recently updated on January 17th, 2024. A total of 60 individuals will be enrolled in the trial across a single location.

Q: What is the level of patient safety when it comes to administering MLT+EPO?

Given that this trial is in Phase 1, our team at Power rates the safety of MLT+EPO as a 1. This rating reflects the limited available data supporting both its safety and efficacy.

Q: Is the inclusion criteria for this study open to individuals aged 65 and above?

To be considered eligible for this clinical trial, applicants must fall within the age range of 12 hours to 2 months. Among the available trials, there are 42 specifically designed for individuals under the age of 18 and 297 intended for those over the age of 65.

Q: Is the enrollment for this medical study currently ongoing?

Indeed, the data available on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible participants. The trial was initially posted on January 16th, 2024 and underwent its most recent update on January 17th, 2024. A total of 60 participants are being sought from a single location.

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

Awards & highlights

SCEMPI Trial Summary

This trial aims to find a safe combination dose of melatonin (MLT) and erythropoietin (EPO) for very premature babies who have severe intraventricular hemorrhage (

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.Check my eligibility

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.See study design

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.

SCEMPI Trial 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.

SCEMPI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of SAE/DLT including death

Secondary outcome measures

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

SCEMPI 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

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,437 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,737 Total Patients Enrolled

Shenandoah Robinson, MDStudy ChairJohns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the number of participants currently enrolled in this clinical study?

"Indeed, the details on clinicaltrials.gov confirm that this research study is actively seeking participants. The trial was initially listed on January 16th, 2024 and recently updated on January 17th, 2024. A total of 60 individuals will be enrolled in the trial across a single location."

Answered by AI

What is the level of patient safety when it comes to administering MLT+EPO?

"Given that this trial is in Phase 1, our team at Power rates the safety of MLT+EPO as a 1. This rating reflects the limited available data supporting both its safety and efficacy."

Answered by AI

Is the inclusion criteria for this study open to individuals aged 65 and above?

"To be considered eligible for this clinical trial, applicants must fall within the age range of 12 hours to 2 months. Among the available trials, there are 42 specifically designed for individuals under the age of 18 and 297 intended for those over the age of 65."

Answered by AI

Is the enrollment for this medical study currently ongoing?

"Indeed, the data available on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible participants. The trial was initially posted on January 16th, 2024 and underwent its most recent update on January 17th, 2024. A total of 60 participants are being sought from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05617833.