Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy, Neonatal Hypoxic Ischemic Encephalopathy, Perinatal Asphyxia
Conditions
Keywords
HIE, intranasal breast milk, perinatal asphyxia, brain, breast milk stem cells, hypoxic-ischemic encephalopathy
Brief summary
This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term neurodevelopmental outcome compared to standard care.
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 open-label prospective randomized controlled single-center interventional study, the objective is to administer fresh, own-mother's breast milk intranasally to neonates with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, starting from the first day of life and continuing for 28 days. The primary objective is to compare neurodevelopmental outcomes between the control group and the intervention group receiving intranasal breast milk treatment. The secondary objective is to compare the progression of enteral feeding and the duration of exclusive breastfeeding between the intervention and the control group.
Interventions
BIOLOGICALIntranasal breast milk
Own-mother's fresh breast milk (within 4 hours of having been expressed), is administered intranasally to neonates with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, starting from the first day of life and continuing for 28 days. Dose: 2 times daily, 0.4 ml in each nostril.
Sponsors
Semmelweis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Hours
Healthy volunteers
No
Inclusion criteria
* Moderate or severe hypoxic- ischemic 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 |
|---|---|---|
| Neurodevelopmental outcome | 2 years | The primary outcome will be the 2 year neurodevelopmental outcome comparing standard care and intranasal breast milk therapy groups. The Bayley Scales of Infant Development, Third Edition (Bayley-III) score will be used to assess neurodevelopmental outcome, favorable outcome is defined as having composite scores for cognitive, language and motor scales \>85, while adverse outcome is defined as composite scores \<80 or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Hungary
Contacts
Primary ContactUnoke Meder, MD, PhD
Backup ContactAgnes Jermendy, MD, PhD
Outcome results
None listed