30
Participants
Start Date
September 10, 2024
Primary Completion Date
January 31, 2025
Study Completion Date
September 10, 2026
Olfactory Testing
Olfactory Test: Odor stimuli will be administered using a custom-designed olfactometer, developed by engineers specifically for this study. The olfactometer will release different odorants (maternal breast milk, vanilla essential oil, rose essential oil, and water as a control) in a controlled way. Each odor will be presented between 6 and 72 hours of life for 10 seconds (On), followed by a 50-second pause (Off) for a total of 15 cycles (On-Off). A new odor will be presented 5 minutes after the previous one. The first olfactory test will be conducted during the Video-EEG recording, and the second one will take place during the fMRI acquisition.
Heart rate (HR), Heart Rate Variability (HRV), Respiratory Rate (RR), peripheral oxygen saturation (SpO2)
Simultaneously with the presentation of odors, heart rate (HR), heart rate variability (HRV), respiratory rate (RR), and peripheral oxygen saturation (SpO2) will be monitored and recorded. The onset of the odor will be recorded using a manual timer.
Video-EEG
The infant's Video-EEG, as per guidelines following perinatal asphyxia, will be recorded for approximately 2 hours, including the period preceding odor administration (baseline).
fMRI
Newborns will undergo an fMRI, as part of routine clinical practice, to identify any brain injury, its extent, and the structures involved. The use of a custom-built fMRI compatible olfactometer will facilitate these studies.
Neurodevelopment assessment
Between 12 and 18 months, the infants will undergo neurodevelopmental follow-up, during which the Bayley III assessment will be administered to evaluate any potential neurocognitive deficits.
RECRUITING
Azienda Ospedaliero-Universitaria di Parma, Parma
Azienda Ospedaliero-Universitaria di Parma
OTHER
University of Parma
OTHER