Assessing Neurological Risks in Infants
Diagnostic Value of the Neonatal Neurological Examination to Detect Infants at Risk for Neurological Abnormalities
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05772416
This study is testing if a detailed neurological exam can help find early signs of brain problems in at-risk infants, like those born very early or showing signs of distress.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 6 Hours to 1 Week |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome) |
| Trial ID | NCT05772416 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a structured neurological examination in identifying early neurological abnormalities in infants who are at risk for such conditions, including very preterm infants and those with signs of asphyxia or convulsions. The infants will undergo a thorough neurological assessment and will be monitored over time to track any developments. The goal is to improve early detection and intervention for neonatal encephalopathy and related neurological issues.
Who should consider this trial
Good fit: Ideal candidates include newborns diagnosed with neonatal encephalopathy or those at risk, such as preterm infants born before 34 weeks or infants exhibiting convulsions.
Not a fit: Patients who do not have neonatal encephalopathy or are not at risk for neurological abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier diagnosis and better management of neurological conditions in at-risk infants.
How similar studies have performed: While similar approaches have been explored, this specific structured examination for early detection in at-risk infants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: all newborns with neonatal encephaolopathy or at risk for neurological abnormlaities, such as preterm infants born below 34 weeks or those with convusions Exclusion Criteria: families unwilling to sign consent
Where this trial is running
Rome
- Policlinico gemelli — Rome, Italy (RECRUITING)
Study contacts
- Principal investigator: Eugenio Mercuri — F Policlinico Gemelli IRCCS
- Study coordinator: Eugenio Mercuri, MD
- Email: eugeniomaria.mercuri@policlinicogemelli.it
- Phone: +39 063015
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.
Conditions: Neonatal Encephalopathy