Actively Recruiting

Age: 6Hours - 72Hours
All Genders
NCT06744244

Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment

Led by University of Parma · Updated on 2024-12-31

30

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

U

University of Parma

Lead Sponsor

A

Azienda Ospedaliero-Universitaria di Parma

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment

Who Can Participate

Age: 6Hours - 72Hours
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 hypoxic-ischemic encephalopathy, who don't need hypothermia treatment
  • Newborns with severe asphyxia at birth, at risk of hypoxic-ischemic encephalopathy, who don't need hypothermia treatment
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy, 43126

Actively Recruiting

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Research Team

S

Serafina Perrone, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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