# HIE target trial protocol

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| 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)<br>2. Caesarean section (at baseline)<br><br>*or would you say each is either at baseline, h1, h2, h3, h4, h5...*?<br><br>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<br>End: Once max time that would deliver cooling at has passed |
| **Statistical analysis** | **Which statistical analyses will be used to estimate the causal estimand?** | ? |