An observational study in Hypoxic Ischaemic Encephalopathy, sponsored by University Children's Hospital, Zurich. Completed at 1 site in Switzerland. Open to participants aged 35 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2018-05-02.
Sponsored by University Children's Hospital, Zurich · Observational
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.
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).
758 studies on the registry are indexed under Brain Diseases; 202 are open to participants now.
This study's enrollment of 160 is above the median of 100 across 265 observational studies indexed under Brain Diseases.
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Neonates born >35 0/7 gestational weeks with clinical signs of hypoxic encephalopathy with Apgar Score\<5 with 10minutes of life, mechanical ventilation with 10minutes of life, pH 7.0 or BE -16mmol/L, lactate >12mmol/L within 60minutes after birth, and seizures or Sarnat staging II-III or Thompson Score >7.
Exclusion Criteria:
investigators will analyze if certain risk factors will influence the progression of the encephalopathy
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
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.
Time frame: 7 days
Plan to share: No
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University Children's Hospital, Zurich