Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment

Recruiting now

Conditions studied: Mild Birth Asphyxia, Moderate Birth Asphyxia

In brief

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.

Key facts

Study ID

NCT06744244

Run by

University of Parma

People needed

30

Starts

2024-09-10

Expected to finish

2026-09-10

Last updated by the study team

2024-12-31

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Infants with scalp injuries or lesions.
• Infants with microcephaly.
• Infants who underwent therapeutic hypothermia.

Where it is running

• Azienda Ospedaliero-Universitaria di Parma — Parma, Italy (enrolling)

Full record on ClinicalTrials.gov

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