Brain Injury, Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Neonatal Hypoxic Ischemic Encephalopathy, Perinatal Asphyxia, Perinatal Asphyxia , Moderate to Severe HIE
Conditions
Keywords
Hypoxic-ischaemic encephalopathy, Neonatal encephalopathy, Perinatal asphyxia, Breast milk, Breast milk stem cells, Intranasal breast milk
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALIntranasal 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).
Sponsors
Semmelweis University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Hours
Healthy volunteers
No
Inclusion criteria
* Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia * ≥ 35. gestational week * \< 48 hours of life * Hypothermia treatment for 72 hours * Parental consent form
Exclusion criteria
* Congenital malformation * Concurrent cerebral lesions * ECMO therapy * Contraindication of lactation * Mother unable or unwilling to provide fresh breast milk * Postpartum asphyxia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients where treatment was initiated within 48 hours | 1 months | Feasibility will be based on the ability to initiate treatment within 48 hours of birth using own mother's fresh milk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events associated with breast milk administration | 1 month | 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 to reach full enteral feeding | 1 month | Time to reach full enteral feeding will be recorded and analyzed as a secondary outcome. |
| Length of exclusive breast feeding | 2 years | Lengths of exclusive breast feeding will be recorded and analyzed as a secondary outcome. |
| Total number of treatments during first months of life | 1 months | Total number of treatments administered in hospital and at home during the first months of life |
Countries
Hungary
Contacts
Primary ContactUnoke Meder, MD, PhD
Backup ContactAgnes Jermendy, MD, PhD
Outcome results
None listed