Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-72
SponsorUniversity of Parma

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Post-term infants (gestational age > 42 weeks).

Preterm infants (gestational age < 37 weeks).

Infants with genetic syndromes or congenital anomalies.

Infants from mothers using drugs of abuse.

Trial design

Treatments tested in this trial

  • Olfactory Testing
  • Heart rate (HR), Heart Rate Variability (HRV), Respiratory Rate (RR), peripheral oxygen saturation (SpO2)
  • Video-EEG
  • fMRI
  • Neurodevelopment assessment

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Parma

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Collaborator