NCT07533162: NEUROMODU

Modular Neurological Examination for Early Risk Detection

Active, enrolled Last updated 16 April 2026

What this trial tests

trial in Clinical Practice Guidelines in 300 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

20 February 2026

Primary endpoint
30 August 2026

30 April 2028

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	300
Start date	20 February 2026
Primary completion	30 August 2026
Estimated completion	30 April 2028
Sites	1 location across Italy

Conditions studied

• Clinical Practice Guidelines — all drugs for Clinical Practice Guidelines →
• Neurological Development — all drugs for Neurological Development →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

Under 2, any sex, with Clinical Practice Guidelines or Neurological Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.