Post-hemorrhagic ventricular dilatation (PHVD) Post-hemorrhagic hydrocephalus (PHH) Post-bleed ventricular enlargement Hydrocephalus following intraventricular hemorrhage (IVH) Progressive ventricular dilation after hemorrhage
Conditions
Interventions
The investigational treatment consists of 0.2ml of milk plasma administered in each nostril of the neonate per administration. The milk plasma will be obtained by subjecting freshly expressed milk fro
Our therapeutic product (milk plasma) is not a drug in the conventional sense, but rather a natural therapeutic product derived from human breast milk. Milk plasma is also known as the liquid portion
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: Admitted to the NICU at the Wilhelmina Children’s Hospital, UMC Utrecht;Diagnosed with PHVD;Indication for Rickham reservoir according to the treating physician;Given written informed consent of parents/caregivers.
Exclusion criteria
Exclusion criteria: Insufficient availability of fresh mother’s milk for the intranasal milk plasma gifts; Did not undergo placement of a Rickham Reservoir following diagnosis; Proven or suspected major congenital anomaly; Chromosomal or metabolic disorder;No realistic prospects of survival (e.g. severe brain injury), at the discretion of the attending physician;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to determine whether intranasal treatment with milk plasma is safe and feasible. Safety is defined primarily as the absence of treatment-related serious adverse events (SAEs) according to the Consolidated Standards of Reporting Trials (chapter 9.2.2). Secondly, safety is defined as the absence of dose-limiting toxicity, described as death within 24 hours after milk plasma administration, or anaphylactic shock related to milk plasma administration. Safety will be monitored from start of the intervention up until 24 hours after the final dose of milk plasma. We will monitor vital signs and evaluate the occurrence of (treatment-related) serious adverse events. Feasibility will be assessed based on two main parameters. Whether all mothers can pump sufficient milk for, at least, a total of seven milk plasma administrations for their neonates, and whether milk plasma can be successfully centrifuged and administered by the study team, within 2 hours of expression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Although this safety and feasibility study is not powered for the following outcomes, we want to explore the effect of intranasal milk plasma administration. We will assess this by analyzing neuroinflammatory and neuroregenerative markers in CSF overtime, using multiplex immunoassays, or proteomics. We will compare biomarker levels of the infants over time, from before start to finish of the treatment. Furthermore, we are interested in comparing the biomarkers in the CSF of these treated patients to markers in the CSF of untreated PHVD patients, that we will obtain from a biobank. Furthermore, we will exploratively assess brain development, based on brain MRI at term equivalent age. We will perform volumetric segmentation, analyze white matter integrity through Tract-Based Spatial Statistics, and Kidokoro scoring for brain injury and growth. We will also monitor and register the incidence of progressive ventricular dilatation and the need to instrument a permanent (ventriculoperitoneal) drain. Finally, we will also explore the effects of intranasal milk plasma treatment on early functional neurological assessments by using the data on the standard follow-up visits for patients with PHVD. Our exploratory outcomes will be compared to data of untreated control PHVD patients, retrieved from a biobank. Finally, maternal milk samples will be collected and analyzed to investigate milk plasma composition, including the quantification of potentially bioactive components that may give neurodevelopmental support in PHVD patients | — |
Countries
Netherlands
Contacts
Public ContactM.J.N.L. Benders
Universitair Medisch Centrum Utrecht
Outcome results
None listed