Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy

NCT02800018 | Completed

• 1 other identifier: 2016-00242
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic Ischaemic Encephalopathy

Keywords

hypothermia therapy; perinatal asphyxia

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Interventions

risk factors OTHER

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

Eligibility Criteria

• Age: 35 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's hospital Zurich

Zurich, 8044, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 31117854 DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Risk Factors

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 15, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 2, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)