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 |