Impact of Erythropoietin in the management of Hypoxic Ischaemic Encephalopathy in resource-constrained settings: protocol for a randomized control trial

Table 3 Outcome measures at different time periods

Domain	Outcome measure	Stage of HIE	T₁ Discharge	T₂ 4 months	T₂ 6 months	T₃ 12 months	T₄ 18 months	T₅ 24 months
Survival	Survival or death	X	X	X	X	X	X	X
Neurologic exam at discharge	Neurologically normal or abnormal	X	X
Cranial Ultrasonography	Cranial USS abnormality	X	X
Neurologic examination at clinic visits	Malawi Developmental Assessment Tool (MDAT) scores			X	X	X	X	X
Laboratory levels of EPO, NRBC, and NRBC/100 WBC	Levels of NRBC and NRBC/100WBC in relation to outcome	X	X
Adverse reactions to EPO	Safety of the medications based on the presence or absence of any adverse event		X	X	X	X	X	X
Gross Motor Function Classification System (GMFCS) assessment system	Those with cerebral palsy are further categorized based on features present on standardized neurologic examination using GMFCS			X	X	X	X	X

T₁₋ T_{5 -} The five time periods for assessment; NRBC Nucleated red blood cells, GMFCS Gross motor function classification system.

ISSN: 1471-2377