Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment

RecruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

September 10, 2024

Primary Completion Date

January 31, 2025

Study Completion Date

September 10, 2026

Conditions
Mild Birth AsphyxiaModerate Birth Asphyxia
Interventions
DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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).

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Trial Locations (1)

43126

RECRUITING

Azienda Ospedaliero-Universitaria di Parma, Parma

All Listed Sponsors
collaborator

Azienda Ospedaliero-Universitaria di Parma

OTHER

lead

University of Parma

OTHER