Erythropoietin for term and late preterm infants with hypoxic ischemic encephalopathy

To determine the effect of therapeutic EPO (with or without hypothermia) compared to no treatment on death, long-term neurodevelopmental disability and clinically important side effects in term and late preterm infants with HIE.

Secondary objectives include assessment of the adverse effects of EPO or EPO plus hypothermia and effects on early prognostic indicators of adverse outcome.

Primary comparisons:

1. trials that assessed EPO as a sole therapy vs. placebo/no treatment

2. trials of EPO plus hypothermia vs. hypothermia alone

Subgroup analyses:

Subgroup analyses are planned on the basis of:

1. Severity of HIE (mild, moderate, severe) (Sarnat 1976; Finer 1981);

2. The dose of EPO:

a) placebo or no intervention vs. low doses of EPO (≤ 1000 IU/kg/week);

b) placebo or no intervention vs. high (> 1000 IU/kg/week, ≤ 3000 IU/kg/week) doses of EPO;

c) placebo or no intervention vs. very high (> 3000 IU/kg/week) doses of EPO;

3. Inclusion criteria:

a) term or late preterm (> 35 weeks gestation);

b) electrophysiological plus clinical criteria vs. clinical criteria alone;

4. Timing of commencement of intervention (< 3 hours vs. 3 to 6 hours vs. > 6 hours);

5. Quality of outcome assessment [high quality (> 18 months with formal psychological testing and review by developmental paediatrician for diagnosis of cerebral palsy) vs. lower quality].

This is a protocol.

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