CompletedNot Applicable

Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy

Switzerland160 participantsStarted 2016-06

Plain-language 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.

Who can participate

Age range

35 Weeks – 42 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 7 days

Trial details

NCT IDNCT02800018

SponsorUniversity Children's Hospital, Zurich

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-12

View on ClinicalTrials.gov More Hypoxic Ischaemic Encephalopathy trials