Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 4:49 AM
Ignite Modification Date: 2025-12-25 @ 4:49 AM
NCT ID: NCT02800018
Brief Summary: The first aim of this study is to analyse perinatal risk factors leading to hypoxic ischaemic encephalopathy in term and near term neonates born in Switzerland who were admitted to the neonatal and intensive care units offering hypothermia therapy. Further, investigators would like to analyse the influence of these perinatal risk factors on the severity of encephalopathy during and after hypothermia therapy.
Detailed Description: Encephalopathy of the neonate could have different aetiologies. Perinatal asphyxia leading to hypoxia-ischaemia is frequent ,1-2 per 1000 life born neonates are affected. Hypoxic ischaemic encephalopathy is one of the most important causes for adverse neurodevelopmental outcome, cerebral palsy, epilepsy and hearing and vision deficiencies in term and near term neonates. Til now, hypothermia therapy is the only therapy reducing the risk of adverse neurodevelopmental outcome and is nowadays standard of care. In this study investigators would like to analyse perinatal risk factors causing HIE and their influence on the Sarnat Score on day 1 and 3 of life (during hypothermia therapy) and on day 4 of life (after hypothermia therapy).
Study: NCT02800018
Study Brief:
Protocol Section: NCT02800018