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 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 signs of asphyxia. Olfactory memory, which can be evaluated through habituation to repeated odors, may provide insights into early brain function. This study aims to evaluate whether olfactory memory can serve as an early marker of neurodevelopmental outcomes in newborns with signs of asphyxia. By assessing physiological, behavioral, and neurological responses to olfactory stimuli, the study seeks to explore the differences between infants with mild asphyxia and those with moderate-to-severe asphyxia.

NCT Number	NCT06744244
Lead Sponsor	University of Parma Collaborators: Azienda Ospedaliero-Universitaria di Parma
Conditions	Mild Birth Asphyxia, Moderate Birth Asphyxia
Enrollment	30 participants
Start Date	2024-09-10
Primary Completion	2025-01 (estimated)
Study Completion	2026-09-10 (estimated)
Updated on ClinicalTrials.gov	2024-12-31