NCT02800018

Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: University Children's Hospital, Zurich · Academic / Other
• Sex: All
• Age: 35 Weeks – 42 Weeks
• Healthy volunteers: Not accepted

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).

Conditions

• Hypoxic Ischaemic Encephalopathy

Interventions

Type	Name	Description
OTHER	risk factors	investigators will analyze if certain risk factors will influence the progression of the encephalopathy

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-06-15
• Last updated: 2018-05-02

Locations

1 site across 1 country: Switzerland