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NCT05617833 · ClinicalTrials.gov registry record · Phase 1
Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage
A Phase 1 study of Intraventricular Hemorrhage of Prematurity, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05617833: Recruiting Phase 1 study of Intraventricular Hemorrhage of Prematurity, sponsored by Johns Hopkins University.
NCT05617833 is a Phase 1 study of Intraventricular Hemorrhage of Prematurity that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 60 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05617833, a Phase 1 study of Intraventricular Hemorrhage of Prematurity, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Very preterm infants are prone to numerous medical complications with lifelong impact. Amongst the most serious are significant intraventricular hemorrhage (sIVH) and the subsequent progression to posthemorrhagic hydrocephalus (PHH). Currently, the only treatment for PHH is surgery, most commonly with shunts that are prone to malfunction across the lifespan. Preclinical data show that melatonin (MLT) and erythropoietin (EPO), when administered in a sustained dosing regimen, can prevent the hallmarks of progression from early postnatal sIVH to subsequent PHH. The investigators will perform a Phase I, single institution, randomized, double-blind trial for very preterm infants with sIVH to define a safe combination dose of MLT and EPO. A maximum of 60 very preterm neonates with sIVH will be enrolled, treated through 33w6/7d, and followed to 37w6/7d. Neonates will be randomized 3:1 between MLT+EPO and placebo, with all receiving standard of care. The primary endpoint is a composite serious adverse event (SAE)/dose limiting toxicity (DLT). The investigators hypothesize that the MLT+EPO SAE/DLT rate will not be higher than the placebo rate. Secondary outcomes will be rate of co-morbidities of preterm birth. Exploratory data, collected to guide design of future clinical trials for efficacy, will include serial neuro-imaging metrics acquired from clinical images, serial neonatal neurodevelopmental examinations, serum and urine MLT and EPO levels, and liquid biomarkers. Successful implementation of this initial safety trial will provide essential data to guide the next stage of clinical trials to test if sustained MLT+EPO treatment can reduce the need for surgical intervention, and avoid the lifelong burden of shunted hydrocephalus.
Conditions Studied
Interventions
- OTHER Placebo
- COMBINATION_PRODUCT MLT+EPO
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-04-30 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05617833
The ClinicalTrials.gov registry entry for NCT05617833 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Intraventricular Hemorrhage of Prematurity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05617833 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05617833 about?
NCT05617833 is a clinical study titled "Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage". Very preterm infants are prone to numerous medical complications with lifelong impact. Amongst the most serious are significant intraventricular hemorrhage (sIVH) and the subsequent progression to posthemorrhagic hydrocephalus (PHH). Currently, the only treatment for PHH is surgery, most commonly wi...
What is the current status of trial NCT05617833?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2024-04-30. Estimated completion is 2027-09-30.
What conditions does trial NCT05617833 study?
This clinical trial studies the following conditions: Intraventricular Hemorrhage of Prematurity.
What interventions are being tested in trial NCT05617833?
The interventions under investigation include: Placebo (OTHER), MLT+EPO (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05617833?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05617833 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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