Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy

NCT ID: NCT02800018

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Hypoxic Ischaemic Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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risk factors

investigators will analyze if certain risk factors will influence the progression of the encephalopathy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Children's hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Scheidegger S, Held U, Grass B, Latal B, Hagmann C, Brotschi B; National Asphyxia and Cooling Register Group. Association of perinatal risk factors with neurological outcome in neonates with hypoxic ischemic encephalopathy. J Matern Fetal Neonatal Med. 2021 Apr;34(7):1020-1027. doi: 10.1080/14767058.2019.1623196. Epub 2019 Jun 4.

Reference Type DERIVED
PMID: 31117854 (View on PubMed)

Other Identifiers

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2016-00242

Identifier Type: -

Identifier Source: org_study_id

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