Pilot study on efficacy and safety of video-EEG monitoring to early identify newborns affected by mild hypoxic-ischemic encephalopathy who may benefit from therapeutic hypothermia: correlation between early video-EEG monitoring and 24-months neurodevelopmental outcome in treated and non-treated newborns.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106302
• EU PAS number:
  EUPAS106301
• Study ID:
  106302
• Official title and acronym:
  Pilot study on efficacy and safety of video-EEG monitoring to early identify newborns affected by mild hypoxic-ischemic encephalopathy who may benefit from therapeutic hypothermia: correlation between early video-EEG monitoring and 24-months neurodevelopmental outcome in treated and non-treated newborns.
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study status:
  Planned

Contact details

Maurizio Radicioni

Study contact

[e-mail]

Maurizio Radicioni

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 27/09/2023

Data collection

Planned: 27/09/2023

Date of final study report

Planned: 31/10/2025

Sources of funding

Other

More details on funding

University Hospital of Perugia

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable