Clinical Trial: Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Evaluation of Perinatal Risk Factors for Hypoxic-ischaemic Encephalopathy (HIE) and Their Influence on Severity of Encephalopathy During and After Hypothermia Therapy

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 Summary: 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).
Sponsor: University Children's Hospital, Zurich

Current Primary Outcome: Number of participants with either antepartal or intrapartal risk factors leading to hypoxic ischaemic encephalopathy and influence of these risk factors on sarnat staging during and after hypothermia therapy [ Time Frame: 7 days ]

The investigators evaluate the incidence of the known antepartal and intrapartal risk factors and analyze if there is a statistically significant difference of the influence of intrapartal or antepartal risk factors on the progression of the encephalopathy during and after hypothermia therapy. The investigators analyze sarnat staging on day one and three as a subject to the forementioned risk factors.


Original Primary Outcome: Number of participants with either antepartal or intrapartal risk factors leading to hypoxic ischaemic encephalopathy and influence of these risk factors on starnat staging during and after hypothermia therapy [ Time Frame: 7 days ]

The investigators evaluate the incidence of the known antepartal and intrapartal risk factors and analyze if there is a statistically significant difference of the influence of intrapartal or antepartal risk factors on the progression of the encephalopathy during and after hypothermia therapy. The investigators analyze sarnat staging on day one and three as a subject to the forementioned risk factors.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Children's Hospital, Zurich

Dates:
Date Received: June 3, 2016
Date Started: June 2016
Date Completion: December 2017
Last Updated: February 6, 2017
Last Verified: January 2017