An Early Phase 1 interventional study of Intranasal breast milk in Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn and Neonatal Encephalopathy, sponsored by Semmelweis University. Recruiting at 1 site in Hungary. Open to participants aged Up to 48 Hours. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Semmelweis University · Early Phase 1, Interventional, and Treatment
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This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.
Perinatal asphyxia and the resulting hypoxic-ischemic encephalopathy (HIE) are the leading cause of neonatal mortality and long-term neurodevelopmental disabilities. Based on our current knowledge, therapeutic hypothermia is the only therapy that has been proven to reduce central nervous system damage in HIE neonates. Improving neurodevelopmental outcomes of newborns with HIE has been an intense area of research over the past decade.
Breast milk is a complex biological substance that contains a variety of bioactive components including neurotrophic growth factors, cytokines, immunoglobulins, and multipotent stem cells. Studies have shown that exclusive breastfeeding in the early stages of development has a positive impact on cognitive outcomes. Animal studies support that mesenchymal stem cells and neurotrophic substances found in breast milk, when administered intranasally enter the central nervous system and reduce the extent of neurological damage. In preterm infants, it has been shown that intranasally administered breast milk is safe and well-tolerated.
In this prospective study our aim is to assess the feasibility and safety of intranasally delivered breast milk to HIE infants treated with hypothermia. Our objective is to administer fresh, own-mother's breast milk intranasally to neonates with HIE starting from the first day of life and continuing for 1 month.
Feasibility will be based on the ability to initiate treatment within 48 hours of birth using own mother's fresh milk expressed within 4 hours and continuing treatment after discharge until day 28. Safety will be assessed through monitoring vital signs and documenting any adverse events. Time to reach full enteral feeding and lengths of exclusive breast feeding will be recorded and analyzed.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
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Contraindication
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Study participants receive their own mother's fresh breast milk, expressed within 4 hours, administered 2 times daily, 0.4 ml in each nostril for 28 days.
Biological: Intranasal breast milk
Neonates with hypoxic-ischemic encephalopathy receive their own-mother's fresh breast milk intranasally, starting from the first 48 hours of life and continuing for 28 days. Dose: 2 times daily, 0.4 ml in each nostril (15 minutes apart).
Proportion of patients where treatment was initiated within 48 hours
Feasibility will be based on the ability to initiate treatment within 48 hours of birth using own mother's fresh milk.
Time frame: 1 months
Number of adverse events associated with breast milk administration
Number of adverse events associated with breast milk administration will be recorded, including desaturation (SpO2\<80%), bradycardia (heart rate \<70% of baseline), apneic episode requiring bag and mask ventilation within 5 minutes of the intervention, or an increase in respiratory support (mode, setting, or FiO2 increase \>10%) within 1 hour of the intervention.
Time frame: 1 month
Time to reach full enteral feeding
Time to reach full enteral feeding will be recorded and analyzed as a secondary outcome.
Time frame: 1 month
Length of exclusive breast feeding
Lengths of exclusive breast feeding will be recorded and analyzed as a secondary outcome.
Time frame: 2 years
Total number of treatments during first months of life
Total number of treatments administered in hospital and at home during the first months of life
Time frame: 1 months
Plan to share: Yes — On special request pending data transfer agreement approval by Semmelweis University.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 20.12.2024.-01.01.2026.
Access criteria: Sharing upon reasonable request.
Data sharing details ↗ · semmelweis.hu
Started Nov 2024 (actual). Primary completion is estimated for Sep 2025, 10 months after the start.
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Studies of the drug tested here: Human milk