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Table 1 Characteristics of included trials

From: A systematic review of cooling for neuroprotection in neonates with hypoxic ischemic encephalopathy – are we there yet?

Included trials Selective head cooling Whole body cooling
  Gunn 1998 Gluckman 2005 Shankaran 2002 Shankaran 2005 Eicher 2005
Design RCT RCT
Multicenter
RCT
Multicenter
RCT
Multicenter
RCT
Multicenter
Number of participants 26 234 19 208 65
Gestation ≥ 37 wks ≥ 37 wks ≥ 36 wks ≥ 37 wks ≥ 35 wks
Inclusion criteria (details see Table 2) Asphyxia and moderate to severe HIE Asphyxia and moderate to severe HIE Asphyxia and moderate to severe HIE Asphyxia and moderate to severe HIE Asphyxia and HIE
Target temperature treatment group (°C) 34.5–35.5 (n = 6)
34.0–35.0 (n = 7)
Not analyzed:
36.0–36.5 (n = 6)
35.5–35.9 (n = 6)
34.0–35.0 34.5 33.5 32.5–33.5
Target temperature control group (°C) 36.8–37.2 36.5–37.5 36.5 36.5–37.0 36.5–37.5
Site of temperature probe Rectal Rectal Esophageal Esophageal Rectal
Average age at start of cooling (min) 294 330 318 302 120
Duration of cooling (h) 48–72 72 72 72 48
Cooling device Servo-controlled cooling cap Servo-controlled cooling cap Two servo-controlled cooling blankets Two servo-controlled cooling blankets Ice bags followed by one servo-controlled cooling blanket
Primary outcome Adverse events Composite of death/severe disability Adverse events Composite of death/moderate or severe disability Adverse events
Latest follow-up (months) 18 18 Follow-up not reported 18–22 12
Follow-up tools Bayley II Bayley II
GMF
- Bayley II
GMF
Bayley II
Vineland