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Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia

NCT05767476 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2023-03-14

No results posted yet for this study

Summary

The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia.

The main questions it aims to answer are:

* Identify patients at risk of neuromotor, cognitive and epileptic sequelae
* Plan early rehabilitation programs and future trials on early neuroprotection in infant at risk of neurodevelopmental disability

Participants will be involved in serial assessment:

* Before and after therapeutic hypothermia and before discharge: neurological assessment, according to the modified Sarna (t) score, Thompson's score and Hammersmith Neonatal Neurological Examination (HNNE); General Movement Assessment
* Amplitude integrated electroencephalogram (aEEG) within 6 hours of life, for 6 hours.
* Neonatal Cranial Ultrasonography within 6 hours of life, in the third and seventh day of life.
* Brain magnetic resonance imaging between 7 and 14 days.
* Electroencephalogram (EEG) within 7 days.

After discharge study population will perform:

* EEG between 3 and 6 months.
* Neurological assessment using Hammersmith Infant Neurological Examination (HINE) at 3-6-9-12 months.
* General Movement Assessment at 3 months.
* Neurodevelopmental assessment using the Griffiths Mental Development Scales at 24 months.
* Cognitive assessment using the Wechsler Preschool and Primary Scale of Intelligence between 36 and 41 months.
* Motor performance assessment using Movement ABC between 42 and 48 months.

Conditions

  • Encephalopathy, Hypoxic Ischemic

Interventions

DIAGNOSTIC_TEST

Clinical and instrumental neurological assessment

Participants will be involved in serial assessment: * Neonatal Cranial Ultrasonography * Brain magnetic resonance imaging * Neurological assessment * Neurodevelopmental and cognitive assessment * Electroencephalogram (EEG) * Motor performance assessment

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Domenico M Romeo, MD,PHD · ChatolicUIT

Eligibility

Min Age
10 Minutes
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2025-08-31
Completion
2027-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05767476 on ClinicalTrials.gov