Milk IntraNasal Therapy in Infants With Posthemorrhagic Ventricular Dilatation: A Safety and Feasibility Study
Key facts
- Phase
- Phase 1/2
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- How often do I need to come in, and for how long each time?
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Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- UMC Utrecht
- Trial code
- NCT07928271
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
Milk Intranasal Therapy (MINT) - Study: A First-in-human Intranasal Milk Plasma Administration in Neonates With Post-haemorrhagic Ventricular Dilatation.
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.
Inclusion: Admitted to the neonatology department 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: Use of medication for which breastfeeding is discouraged according to Lareb ("Moeders van Morgen") (e.g. due to potential harmful effects for the neonate), as assessed by the treating physician; Chromosomal or metabolic disorder; Insufficient availability of fresh mother's milk for the intranasal milk plasma gift; Did not undergo placement of a Rickham Reservoir following diagnosis; Proven or suspected major congenital anomaly; No realistic prospects of survival (e.g., severe brain injury), at the discretion of the attending physician.