Olfactory testing to assess risk in newborns with birth asphyxia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.