A Phase 1/2 interventional study of Milk plasma in Hydrocephalus in Infants and IVH- Intraventricular Hemorrhage, sponsored by UMC Utrecht. Enrolling by invitation at 1 site in Netherlands. Open to participants aged 24 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by UMC Utrecht · Phase 1/2, Interventional, and Treatment
In this open label phase I/II safety and feasibility study, the investigators use milk plasma, which is filtered breast milk from which fats and cells have been removed. Milk plasma contains substances such as proteins, milk vesicles, and fatty acids, that may help protect the brain and support recovery.
These substances can reach the brain directly through the nose. Studies in animals and early studies in newborn children suggest that breast milk administered through the nose may reduce inflammation and may help brain recovery. The investigators think milk plasma may work even better because it is filtered and can reach the brain more easily, but this is still uncertain.
So far, no harmful side effects were found with the use of breast milk through the nose. Because milk plasma through the nose has not yet been studied in babies with PHVD in the Netherlands, in this study investigators are focusing on safety and how well the treatment is tolerated in these patients. In addition, the researchers want to explore if the milk plasma has an effect on the brain. This is done by measuring certain factors in the cerebrospinal fluid and blood.
190 studies on the registry are indexed under Hydrocephalus; 52 are open to participants now.
This study's planned enrollment of 15 is below the median of 41 across 97 interventional studies indexed under Hydrocephalus.
Browse Hydrocephalus studies →UMC Utrecht is the lead sponsor of 364 studies on the registry; 82 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants of this study receive 7 to 14 intranasal milk plasma administrations
Dietary Supplement: Milk plasma
Milk plasma is human breast milk devoid of fats and cells
Safety of intranasal milk plasma administration
Safety will be assessed by monitoring treatment-related (serious) adverse events from the first administration until 1 hour after the final dose.
Time frame: During the 14 day intervention period
Feasibility of intranasally administering fresh milk plasma
Feasibility will be assessed by the proportion of mothers able to provide sufficient fresh milk for at least seven doses and the ability of the study team to prepare and administer the plasma within two hours of milk expression.
Time frame: During the 14 day intervention period
Started Jan 2026 (actual). Primary completion is estimated for Jan 2028, 23 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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