Modular Neurological Examination for Early Risk Detection

NCT07533162 | Active Not Recruiting

• 1 other identifier: 17127
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the availability of increasingly sophisticated instrumental examinations, the neurological assessment of the neonate and infant remains an effective, non-invasive, rapid, and cost-effective method for evaluating the integrity of the nervous system. It represents a fundamental component of the child's overall assessment, allowing for the early identification of risk factors for the development of neurological disorders. Although this examination is part of routine clinical practice, the methods by which it is performed are often suboptimal. Over time, several attempts have been made to systematise the neurological examination through the development of standardised tools designed to assess both strictly neurological and behavioural aspects (Prechtl and Brazelton). The Hammersmith Neonatal Neurological Examination (HNNE) and the Hammersmith Infant Neurological Examination (HINE) currently represent the most widely used instruments in both clinical and research settings, providing an effective means for the early diagnosis of neurological sequelae in children at both low and high risk of neurological damage between 0 and 24 months of age. Through a modular tool (Cutrona C et al., Eur J Pediatr, 2025), which requires no more than 15 minutes to administer, it is possible to perform systematic screening with a validated instrument, thereby identifying patients who require further evaluation. In cases where this examination highlights suspicious clinical findings, additional tools can be employed to assess more specific aspects such as hypotonia or visual disorders. This modular system, developed as a modification of a neurological examination already in worldwide use at our Centre (Dubowitz, Dubowitz, Mercuri, 2000) and representing the gold standard reference for the present study, requires further validation in light of new paediatric care standards, which have evolved over the past 20 years since the validation of the original examination.

Conditions

Clinical Practice Guidelines; Neurological Development

Outcome Measures

Primary Outcomes (1)

• Modular Neurological Examination

  Modular Neurological Examination for Early Risk Detection

  From enrollment to the end of follow-up at 2 years

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates and infants followed by the Child Neuropsychiatry Service of the A. Gemelli University Hospital Foundation IRCCS

You may qualify if:

• Patients attending the Child Neuropsychiatry Service of the A. Gemelli University Hospital Foundation IRCCS, aged between 0 and 24 months.
• Patients whose parents/legal guardians have signed the informed consent form.

You may not qualify if:

• Refusal to provide informed consent.
• Inability to undergo the neurological examination due to clinical conditions that prevent its administration.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Location

Study Officials

• Domenico Marco Romeo

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

IT (1)