Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment

Launched by UNIVERSITY OF PARMA · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a newborn's sense of smell might help doctors understand the impact of mild to moderate birth asphyxia, a condition where babies don't get enough oxygen at birth. Researchers believe that the ability of babies to recognize and remember smells could indicate how well their brains are functioning and help identify those who are at risk for long-term developmental issues. By comparing how babies with different levels of asphyxia respond to various odors, the study aims to find early signs that could guide treatment and support.

To participate, babies must be full-term (born between 37 to 41 weeks) and show signs of asphyxia, such as low scores on a quick health assessment taken right after birth. The trial is currently looking for participants who are 0 to 3 years old, and it’s important that their mothers did not use certain medications during pregnancy. Families who join the study can expect to have their baby involved in sensory tests focusing on smell, which will be done in a safe and supportive environment. This research could lead to better ways to identify and help babies who may face challenges in their development due to asphyxia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 developing hypoxic-ischemic encephalopathy, who don't need hypothermia treatment.
• • Newborns with severe asphyxia at birth, at risk of developing hypoxic-ischemic encephalopathy who don't need hypothermia treatment.
• Exclusion Criteria:
• • 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.