Actively Recruiting
Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2023-03-14
70
Participants Needed
2
Research Sites
348 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants with gestational age 35 weeks or older
- Infants with body weight of 1800 grams or more
- Evidence of intrapartum hypoxia with pH ≤ 7.0 or base excess ≥ 16 mmol/L within first hour of life, or pathological intra-partum events, or Apgar score ≤ 5 or need for continuous respiratory support at 10 minutes
- Signs of moderate or severe encephalopathy at 30-60 minutes of life based on modified Sarna (t) score: stage 2 or stage 3
- Amplitude integrated EEG or EEG for at least 30 minutes showing moderate or severe abnormalities or presence of convulsions
- Underwent therapeutic hypothermia for 72 hours according to guidelines
You will not qualify if you...
- Gestational age less than 35 weeks
- Severe fetal growth restriction (body weight less than 1800 grams)
- Inability to start therapeutic hypothermia within 6 hours of birth
- Known other causes of encephalopathy such as chromosomal abnormalities, brain malformations, metabolic encephalopathies, major congenital anomalies, or neonatal withdrawal syndrome
- Incoercible bleeding
- Refusal of consent by parent, guardian, or legal representative
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Domenico Marco Romeo
Rome, Italy, 00168
Actively Recruiting
2
Fondazione Policlinico Universitario Agostino Gemelli -IRRCS
Rome, Italy, 00168
Actively Recruiting
Research Team
D
Domenico M Romeo, MD,PHD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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