Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy

Completed

• Conditions: Hypoxic Ischaemic Encephalopathy

• Registration Number: NCT02800018
• Lead Sponsor: University Children's Hospital, Zurich

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-15
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• This study includes data of neonates suffering from hypoxic-ischaemic encephalopathy born with a gestational age > 35 0/7 weeks, who were admitted to the neonatal and intensive care units in Switzerland between 2011-2013 and were treated with therapeutic hypothermia.

Exclusion Criteria

• Neonates with hypoxic-ischaemic encephalopathy, born with a gestational age < 35 0/7 weeks or without hypothermia treatment or syndromal diseases or with malformations were excluded.
• Further, children without consent to research use were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University Children's hospital Zurich; 🇨🇭 Zurich, Switzerland