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

Recruiting Observational Study
Encephalopathy, Hypoxic Ischemic
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
10 Minutes – 6 Hours
Sex
Any
Study type
Observational
Participants needed
70 (estimated)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Other
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About This Trial
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 ea…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:All infants with gestational age ≥ 35 weeks and with a body weight ≥ 1800 g were considered eligible, if they satisfied the following criteria: * 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,…
Contacts

Domenico M Romeo, MD,PHD

00390630156391

domenicomarco.romeo@policlinicogemelli.it

CONTACT