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

NCT05767476 | Recruiting

• 1 other identifier: 3544
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental outcome

  the score in Griffiths Mental Development Scales (GMDS)

  24th months

Secondary Outcomes (2)

• Neurodevelopmental outcome

  between 36th and 42th months

• Motor coordination outcome

  between 42th and 48th months.

Study Arms (1)

Newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia

Diagnostic Test: Clinical and instrumental neurological assessment

Interventions

Clinical and instrumental neurological assessment DIAGNOSTIC_TEST

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

Newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia

Eligibility Criteria

• Age: 10 Minutes - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypotermia

You may qualify if:

• Intrapartum hypoxia defined as follows: potential of hydrogen (pH)≤ 7.0 or B.E. ≥ 16 millimole liters (mmo/L) in the 1st hour of life, obtained from cord or arterial blood, or (ii) pathological intra-partum course (e.g., abnormal foetal heart rate, cord prolapse, uterine rupture, maternal haemorrhage/trauma/epileptic seizures/cardiorespiratory arrest, shoulder dystocia, fluid meconium-stained amniotic), or Apgar score ≤5 or continuous respiratory support at 10 minutes.
• Signs of moderate or severe encephalopathy according to the Sarna (t) score and Sarna (t) staging, performed at 30-60 minutes of life: stage 2 (lethargic, poor spontaneous activity, distal flexion posture, hypotonia, weak primitive reflexes, myotic pupils, bradycardia or periodic breathing) or stage 3 (stupor/coma, decerebrate posture, spontaneous activity absent, flaccidity, primitive reflexes absent, non-reactive pupils or apnoea).
• Amplitude integrated electroencephalogram( aEEG ) by Cerebral Functional Monitoring (CFM) or electroencephalogram (EEG) for at least 30 minutes, which shows either moderate or severe electroencephalographic anomalies, or the presence of convulsions.
• All enrolled infants underwent therapeutic hypothermia according to the international guideline for 72 hours.

You may not qualify if:

• Infants with:
• gestational age \<35 weeks,
• severe foetal growth restriction (body weight \<1800 g),
• inability to start therapeutic hypothermia within 6 hours of birth,
• other known causes of encephalopathy (chromosomopathies, brain malformations, metabolic encephalopathies, major congenital anomalies, neonatal withdrawal syndrome), - incoercible bleeding,
• refusal of consent by the parent/guardian/legal representative

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

Domenico Marco Romeo

Rome, 00168, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli -IRRCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Domenico M Romeo, MD,PHD

  ChatolicUIT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico M Romeo, MD,PHD

CONTACT

00390630156391; domenicomarco.romeo@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 14, 2023
• Study Start: April 28, 2021
• Primary Completion: August 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 14, 2023

Record last verified: 2023-02

Locations

IT (2)