Actively Recruiting

Age: 6Hours - 72Hours
All Genders
ID06744244

Olfactory Memory as an Early Marker of Brain Function in Newborns With Signs of Perinatal Asphyxia Assessment of Neurodevelopmental Outcomes Using Odor Tests and Brain Monitoring

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 is a major cause of long-term neurological disabilities despite advances in care, affecting 1 to 3 infants per 1,000 live births in developed countries. This research evaluates whether olfactory memory, or the ability to recognize and remember smells, can serve as an early indicator of neurodevelopmental outcomes in newborns showing signs of asphyxia. The study focuses on newborns with mild to moderate-severe asphyxia and investigates their physiological, behavioral, and neurological responses to smells. The study uses a custom-designed device to deliver odors such as maternal breast milk, vanilla, and rose in controlled cycles between 6 and 72 hours after birth. During this olfactory testing, heart rate, breathing rate, oxygen levels, and brain activity (via video-EEG) are monitored. Newborns also undergo brain imaging (fMRI) with the odor tests to observe brain areas involved in smell perception, memory, and learning. Later, between 12 and 18 months, infants have a follow-up neurodevelopmental assessment using the Bayley III test. Participants will be closely observed during odor exposure and brain monitoring sessions lasting about 2 hours. Researchers measure changes in heart rate, breathing patterns, brain rhythms, and behavioral responses to smells. They also analyze brain imaging and EEG data to understand the effects of asphyxia on olfactory brain function. The study aims to identify early markers that could help predict developmental outcomes and guide timely interventions in asphyxiated newborns.

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

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

Frequently Asked Questions

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Published Research Related To This Trial

Therapeutic Hypothermia Modulates the Relationships Between Indicators of Severity of Neonatal Hypoxic Ischemic Encephalopathy and Serum Biomarkers.

Raul Chavez-Valdez, Sarah Miller, Harisa Spahic...

https://pubmed.ncbi.nlm.nih.gov/34795631

Two-Year Neurodevelopmental Outcomes After Mild Hypoxic Ischemic Encephalopathy in the Era of Therapeutic Hypothermia.

Mikael Finder, Geraldine B Boylan, Deirdre Twomey...

https://pubmed.ncbi.nlm.nih.gov/31710357

Sensory deficits and olfactory system injury detected by novel application of MEMRI in newborn rabbit after antenatal hypoxia-ischemia.

Alexander Drobyshevsky, Alan M Robinson, Matthew Derrick...

https://pubmed.ncbi.nlm.nih.gov/16861007

Mild intermittent hypoxemia in neonatal mice causes permanent neurofunctional deficit and white matter hypomyelination.

Courtney Juliano, Sergey Sosunov, Zoya Niatsetskaya...

https://pubmed.ncbi.nlm.nih.gov/25476492

Breastmilk as a Multisensory Intervention for Relieving Pain during Newborn Screening Procedures: A Randomized Control Trial.

Hsiang-Yun Lan, Luke Yang, Chiao-Hsuan Lin...

https://pubmed.ncbi.nlm.nih.gov/34948633
Olfactory Memory as an Early Marker of Brain Function in Newborns With Signs of Perinatal Asphyxia Assessment of Neurodevelopmental Outcomes Using Odor Tests and Brain Monitoring | DecenTrialz