Trial documents

This section provides access to key documents for sites participating in the COMET trial.

Protocol

326176_Protocol_v5.1_29.10.25_Clean

 

Participant Information sheet (PIS)

326176_PIS_Cooling Centre_v5.0_10.07.25_Clean

326176_PIS_Non-Cooling Centre_v5.0_10.07.25_Clean

326176_PIS_Video Recording NA_v4.0_10.07.25_Clean

Informed Consent Form (ICF)

326176_ICF_Cooling Centre_v5.0_10.07.25_Clean

326176_ICF_Non-Cooling Centre_v5.0_10.07.25_Clean

326176_ICF_Telephone_v4.0_10.07.25_Clean

326176_ICF_Video Recording NA_v4.0_10.07.25_Clean

Parent Flyer & Poster

326176_Parent_Flyer_v1.0_10.07.2025_Clean

326176_Parent Poster_v1.1_29.10.25_Clean

Parent Information Videos

https://www.youtube.com/watch?v=11V43IBYF0s

https://www.youtube.com/watch?v=tvWwAPAZ4o0

 

 

Standard Operating Procedures (SOPs)

Expanded Modified Sarnat staging v3.2

Randomisation v1.0

Video & Data Transfer v2.0

Managing & Reporting AE

Case Report Form (CRF)

COMET_CaseReportForm_v1.8

MNSI Referral Process

Joint Statement on MNSI Referrals for COMET Babies

20 Years of Landmark Trials in HIE Neuroprotection

Shankaran et al., NEJM 2005

Azzopardi et al., NEJM 2009

Shankaran et al., JAMA 2017

Laptook et al., JAMA 2017

Thayyil et al., Lancet GH 2021

Faix et al., JAMA Pediatrics 2025