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Modular Neurological Examination for Early Risk Detection

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Summary

NIH's ClinicalTrials.gov registered observational study NCT07533162 to validate a modular neurological screening tool for infants. The study evaluates the Hammersmith Infant Neurological Examination (HINE) and a novel modular tool requiring approximately 15 minutes to administer, aimed at early identification of infants requiring further neurological evaluation. The research focuses on infants from birth to 24 months across both low and high-risk populations for neurological damage.

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What changed

This registration documents a new observational clinical trial (NCT07533162) examining modular neurological examination tools for early risk detection in infants. The study validates a 15-minute standardized screening tool based on the Hammersmith Neonatal/Infant Neurological Examination (HNNE/HINE), designed to systematically identify infants requiring further neurological evaluation.

For healthcare providers and clinical investigators, this trial represents an emerging evidence base for standardized neurological screening practices. The study focuses on clinical practice guidelines for neurological development assessment in infants, potentially informing future best practices for early identification of infants at risk for neurological sequelae.

Archived snapshot

Apr 16, 2026

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Modular Neurological Examination for Early Risk Detection

Observational NCT07533162 Kind: OBSERVATIONAL Apr 16, 2026

Abstract

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, addit...

Conditions: Clinical Practice Guidelines, Neurological Development

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07533162

Who this affects

Applies to
Healthcare providers Clinical investigators Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Neurological screening Medical research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Public Health Medical Devices

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