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โ† Trials
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Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment

Recruitingn/aAges 6 Hours - 72 HoursAllUniversity of Parma
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In plain words

What the trial is, and whether it could suit you

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,

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 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.
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What it tests

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

1 site
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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