NCT06744244 Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment
| NCT ID | NCT06744244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Parma |
| Condition | Mild Birth Asphyxia |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-09-10 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-09-10 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
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.
Contact & Investigator
Serafina Perrone, MD, PhD
PRINCIPAL INVESTIGATOR
Università di Parma
Frequently Asked Questions
Who can join the NCT06744244 clinical trial?
This trial is open to participants of all sexes, aged 6 Hours or older, up to 72 Hours, studying Mild Birth Asphyxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06744244 currently recruiting?
Yes, NCT06744244 is actively recruiting participants. Contact the research team at serafina.perrone@unipr.it for enrollment information.
Where is the NCT06744244 trial being conducted?
This trial is being conducted at Parma, Italy.
Who is sponsoring the NCT06744244 clinical trial?
NCT06744244 is sponsored by University of Parma. The principal investigator is Serafina Perrone, MD, PhD at Università di Parma. The trial plans to enroll 30 participants.