Milk IntraNasal Therapy in Infants With Posthemorrhagic Ventricular Dilatation: A Safety and Feasibility Study

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1 / Phase 2

Age range

24 weeks - 42 weeks

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

15 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• 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 Criteria:

• 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;
• Chromosomal or metabolic disorder;
• No realistic prospects of survival (e.g., severe brain injury), at the discretion of the attending physician;
• 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

UMC Utrecht

Study start

Jan 21, 2026 Actual

Primary completion

Jan 1, 2028 Estimated

Study completion

Jan 1, 2029 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.