Olfactory testing to assess risk in newborns with birth asphyxia
Olfactory Memory in Infants With Signs of Asphyxia: An Early Indicator of Neurodevelopmental Outcomes
This study is testing if smelling different scents can help find newborns with mild to moderate birth asphyxia who might be at risk for serious brain problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 6 Hours to 72 Hours |
| Sex | All |
| Sponsor | University of Parma Academic / other |
| Locations | 1 site (Parma) |
| Trial ID | NCT06744244 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the olfactory function in term newborns who exhibit signs of mild to moderate birth asphyxia. By assessing olfactory memory through habituation to repeated odors, the study aims to identify newborns at high risk for hypoxic-ischemic encephalopathy, a severe neurological condition. The methodology includes olfactory testing alongside monitoring vital signs and neurodevelopmental assessments. Early identification of at-risk infants could facilitate timely interventions to improve their outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are term newborns (37-41 weeks gestational age) with signs of mild to moderate asphyxia at birth.
Not a fit: Patients who are preterm, post-term, or have significant congenital anomalies or genetic syndromes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early identification and intervention strategies for newborns at risk of neurodevelopmental disabilities due to birth asphyxia.
How similar studies have performed: While olfactory function has been studied in adults with neurological disorders, this approach in newborns with asphyxia is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Parma
- Azienda Ospedaliero-Universitaria di Parma — Parma, Italy (Recruiting)
Study contacts
- Principal investigator: Serafina Perrone, MD, PhD — Università di Parma
- Study coordinator: Serafina Perrone, MD, PhD
- Email: serafina.perrone@unipr.it
- Phone: 3388704211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.