HIE
Collaborative
The NBS HIE Collaborative is a global, multicenter retrospective study on neonatal hypoxic-ischemic encephalopathy (HIE). Led through the Newborn Brain Society it’s aimed to advance our collective understanding of the incidence, management, and outcomes of HIE around the world. This collaborative will focus on retrospective data collection for neonates treated with therapeutic hypothermia during the period January to December 2024, using a standardized data collection form.
Team: Pia Wintermark, Eric Peeples
Join the Collaborative
1.
Access the study protocol.
2.
Access the initial IRB/ethics approval.
3.
Review the list of CORE data elements to be collected.
4.
Download the draft DTA/DUA and share it with your legal team.
5.
Submit Your Documents.
- Submit documents and questions to Pia Wintermark pia.wintermark@mcgill.ca.
- For help with legal, please reach out to Tiana Derochette (CUSM) at tiana.derochette@muhc.
mcgill.ca.
6.
Data will be entered via REDCap, hosted by Pia Wintermark and the Research Institute of the McGill University Health Centre.
7.
Once your site has completed IRB approval and DUA finalization, we will reach out to schedule an onboarding session and provide REDCap access.
Frequently Asked Questions
Can I review the data sheet before committing? Yes! A draft of the data sheet is available here: https://form.jotform.com/
250358396626062. For this retrospective study, we are focusing on collecting only core data elements. We welcome your feedback on potential modifications. Are the collected data similar to VON? No, this dataset is not based on VON. The data sheet was developed through consensus discussions within the NBS Guidelines and Publications Committee to standardize HIEdata collection.
Will a central IRB be used? No, we are not using a central IRB, as this is a global initiative. Each participating site will need to obtain local IRB or Research Ethics Committee (REC) approval before data collection. The finalized study protocol will be shared with all interested centers soon.
What about the data sharing agreement? The data sharing agreement will be distributed along with the study protocol.
Is there funding available for this initiative? Unfortunately, there is no funding for this initiative. Participation is entirely voluntary, and sites must agree to contribute data without additional financial support.
Our site has only a few cases per year. Can we still participate? Yes! We encourage participation even if your site cools only a few neonates per year.
What if my center does not provide cooling for neonates with HIE? For this first initiative, we are only collecting data on cooled neonates with HIE.