Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)

Table 1 Study examinations and data collection

*Procedure*	*Initial hospitalization*			*Outpatient*
*Time range from birth*	0–24 h	At a predefined time before discharge	discharge	2 years
*Screening*	✓
*Randomization and first dose of study medication*	✓
*Full written informed consent*		✓
*Baseline — infant data*		✓
*Baseline — maternal data*		✓
*Hypothermia treatment and 2nd dose of study medication*		✓
*Thompson score at 1–6 h and 84–106 h or discharge (whichever comes first)*	✓	✓
*Blood gas analysis*	✓✓
*Cell injury markers and hypereosinophilia*	√	✓
*Neonatal outcome until day 14*		✓
*aEEG (in case of hypothermia until 84 h)*	✓
*mchEEG*		✓
*Peroxidase products, blood*	✓✓
*Peroxidase products, urine*	✓✓
*Head ultrasound*	✓	✓✓
*S100B and inflammasome-mediated cytokines*	✓	✓
*MRI*		✓
*Discharge*			✓
*Adverse events*	Continuously
*Follow-up*				✓
*End of study*				✓

ISSN: 1745-6215