Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment
Neonatal asphyxia remains a leading cause of neurodevelopmental disabilities despite advancements in perinatal care. Hypoxic-ischemic encephalopathy (HIE), a severe outcome of asphyxia, impacts 1-3 infants per 1,000 live births annually in industrialized nations, causing long-term neurological impairments such as cogni
| Condition(s) | Mild Birth Asphyxia, Moderate Birth Asphyxia |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Neonatal asphyxia remains a leading cause of neurodevelopmental disabilities despite advancements in perinatal care. Hypoxic-ischemic encephalopathy (HIE), a severe outcome of asphyxia, impacts 1-3 infants per 1,000 live births annually in industrialized nations, causing long-term neurological impairments such as cognitive dysfunction, motor deficits, and sensory impairments. Early identification of at-risk newborns is critical to initiate timely interventions and improve outcomes. Olfactory perception, crucial for newborns' adaptation to extrauterine life, involves odor identification and memory. Odor perception is known to be impaired in adults with neurological disorders and in animal models of brain injury. However, no clinical studies have assessed olfactory function in newborns with |
| Who can participate | Inclusion Criteria: * Term newborns (37-41 weeks of gestational age) with signs of asphyxia at birth (cord pH \< 7.10 and/or BE \> -12). * Maternal age \> 18 years. * No medication use during pregnancy (e.g., antipsychotics, antidepressants, sedatives, anticonvulsants, anxiolytics). * Absence of maternal infections. * Apgar score \< 5 at 10 minutes of life. * Newborns with mild asphyxia at birth. * Newborns with moderate asphyxia at birth, at risk of developing hypoxic-ischemic encephalopathy, who don't need hypothermia treatment. * Newborns with severe asphyxia at birth, at risk of developing hypoxic-ischemic encephalopathy who don't need hypothermia treatment. Exclusion Criteria: * Post-term infants (gestational age \> 42 weeks). * Preterm infants (gestational age \< 37 weeks). * Infants |
| Ages | 6 Hours to 72 Hours |
| Sex | All |
| Lead sponsor | University of Parma |
| Locations | Parma, Italy |
| Start date | 2024-09-10 |
| NCT ID | NCT06744244 |
| Official listing | https://clinicaltrials.gov/study/NCT06744244 |