HIE target trial protocol

to complete

Protocol element	Description	Target Trial	Subsequent observational study
Eligibility criteria	Who will be included in this study?	- Term/near-term pregnancy
Treatment strategies	Which precise treatment strategies or interventions will eligible individuals receive?	1. Vaginal birth (ignore time it takes) 2. Caesarean section (at baseline) or would you say each is either at baseline, h1, h2, h3, h4, h5…? Or would it be vaginal birth or elective caesarean? And then loss to treatment is the people who get emergency caesarean?
Outcomes	What outcomes will be measured during follow-up?	Whether infant receives cooling treatment
Causal estimand	Which causal estimand will be estimated with the observational data?	?
Start and end of follow-up	When does follow-up start and when does it end?	Start: Point of randomisation End: Once max time that would deliver cooling at has passed
Statistical analysis	Which statistical analyses will be used to estimate the causal estimand?	?