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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: Newborn
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Domenico Marco Romeo
RECRUITING
Rome
Fondazione Policlinico Universitario Agostino Gemelli -IRRCS
RECRUITING
Rome
Contact Information
Primary
Domenico M Romeo, MD,PHD
domenicomarco.romeo@policlinicogemelli.it
00390630156391
Time Frame
Start Date: 2021-04-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 70
Treatments
Newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov