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/34795631Actively Recruiting
Led by University of Parma · Updated on 2024-12-31
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
U
University of Parma
Lead Sponsor
A
Azienda Ospedaliero-Universitaria di Parma
Collaborating Sponsor
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
Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment
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Total: 1 location
1
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43126
Actively Recruiting
S
Serafina Perrone, MD, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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