Modular Neurological Examination for Early Risk Detection (NEUROMODU)

Application of the Modular Neurological Examination in the Early Identification of Children at Risk for Neurological Pathologies

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. 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, 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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Clinical Practice Guidelines; Neurological Development

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hammersmith Neonatal Neurological Examination (HNNE)	Modular Neurological Examination for Early Risk Detection. A score above 30.5 is considered normal, whereas a score below 30.5 is considered pathological.	From enrollment to the end of follow-up at 2 years
Hammersmith Infant Neurological Examination (HINE)	Modular Neurological Examination for Early Risk Detection. Global scores are reported as optimal if they are equal orabove 73 at 9 to 12 months, or equal or above 70 and 67 at 6 months and 3 months respectively.	From enrollment to the end of follow-up at 2 years

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Domenico Marco Romeo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 17127

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No