Identifying microRNA to improve management of newborn brain injury
Role of microRNAs as Diagnostic and Prognostic Biomarkers of Neonatal Perinatal Asphyxia and Hypoxic Ischemic Encephalopathy
This study is trying to find specific microRNAs in newborns with brain injury to help doctors better manage their care and improve outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 35 Weeks to 42 Weeks |
| Sex | All |
| Sponsor | Ospedale Buon Consiglio Fatebenefratelli Academic / other |
| Locations | 2 sites (Naples and 1 other locations) |
| Trial ID | NCT05986994 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on hypoxic-ischemic encephalopathy, a leading cause of neurological damage in newborns. It aims to identify reliable biomarkers, specifically microRNAs, to enhance the early management and prognosis of affected infants. The study highlights the limitations of current diagnostic tools and emphasizes the need for timely neurological evaluation within the first hours of life. By profiling microRNAs in biological samples, the research seeks to improve the identification of infants who may benefit from therapeutic hypothermia.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns with at least 35 weeks of gestational age and a body weight of at least 1800 grams.
Not a fit: Patients who withdraw informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early management and outcomes for newborns suffering from hypoxic-ischemic encephalopathy.
How similar studies have performed: While the approach of using microRNA profiling is relatively novel, similar studies have shown promise in identifying biomarkers for other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * newborns with at least 35 weeks of gestational age * body weight of at least 1800 g Exclusion Criteria: * Withdrawal of informed consent
Where this trial is running
Naples and 1 other locations
- Department of Neuroscience, Reproductive and Dentistry Sciences, University of Naples Federico II — Naples, Italy (Recruiting)
- Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital — Napoli, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppe De Bernardo, Prof — Buon Consiglio Fatebenefratelli Hospital
- Study coordinator: Giuseppe De Bernardo, MD
- Email: pinodebtin@gmail.com
- Phone: 3357441303
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.