Ref (type) | Population | Outcome, Interventions | Results and statistical analysis | Effect size | Favours |
Adverse effects | |||||
Systematic review |
31 infants Data from 1 RCT |
Sinus bradycardia
with hypothermia with normothermia Absolute results not reported |
RR 2.21 95% CI 0.1 to 50.3 |
Not significant | |
Systematic review |
31 infants 2 RCTs in this analysis |
Need for inotrope support
with hypothermia with normothermia Absolute results not reported |
RR 2.41 95% CI 0.82 to 7.08 |
Not significant | |
Systematic review |
31 infants Data from 1 RCT |
Anaemia requiring blood transfusion
with hypothermia with normothermia Absolute results not reported |
RR 3.68 95% CI 0.19 to 70.9 |
Not significant | |
Systematic review |
31 infants Data from 1 RCT |
Hypokalaemia
with hypothermia with normothermia Absolute results not reported |
RR 1.16 95% CI 0.49 to 2.73 |
Not significant | |
Systematic review |
31 infants Data from 1 RCT |
Oliguria
with hypothermia with normothermia Absolute results not reported |
RR 0.67 95% CI 0.22 to 2.03 |
Not significant | |
Systematic review |
31 infants Data from 1 RCT |
Coagulopathy resulting in major thrombosis or haemorrhage
with hypothermia with normothermia Absolute results not reported |
RR 3.68 95% CI 0.19 to 70.9 |
Not significant | |
Systematic review |
31 infants Data from 1 RCT |
Culture-proven sepsis
with hypothermia with normothermia Absolute results not reported |
RR 0.72 95% CI 0.05 to 10.52 |
Not significant | |
RCT |
67 term infants with moderate/severe neonatal encephalopathy after perinatal asphyxia |
Bradycardia
11/31 (35%) with systemic hypothermia 2/31 (6%) with normothermia |
RR 5.5 95% CI 1.33 to 22.8 |
Large effect size | normothermia |
RCT |
67 term infants with moderate/severe neonatal encephalopathy after perinatal asphyxia |
Plasma transfusions for coagulopathy
23/31 (74%) with systemic hypothermia 11/31 (35%) with normothermia |
RR 2.09 95% CI 1.25 to 3.51 |
Moderate effect size | normothermia |
RCT |
67 term infants with moderate/severe neonatal encephalopathy after perinatal asphyxia |
Mean duration of inotrope support
5 days with systemic hypothermia 2 days with normothermia |
P = 0.02 |
Effect size not calculated | normothermia |
RCT |
234 newborn infants with clinical and electroencephalographic evidence of moderate or severe neonatal (hypoxic–ischaemic) encephalopathy |
Sinus bradycardia
10/112 (9%) with therapeutic cooling of the infant's head and mild systemic hypothermia 1/118 (1%) with normothermia |
RR 10.5 95% CI 1.37 to 80.97 |
Large effect size | normothermia |
RCT |
234 newborn infants with clinical and electroencephalographic evidence of moderate or severe hypoxic–ischaemic encephalopathy |
Hypotension
62/112 (55%) with therapeutic cooling of the infant's head and mild systemic hypothermia 61/118 (52%) with normothermia |
RR 1.07 95% CI 0.84 to 1.36 |
Not significant | |
RCT |
234 newborn infants with clinical and electroencephalographic evidence of moderate or severe hypoxic–ischaemic encephalopathy |
Coagulopathy
21/112 (19%) with therapeutic cooling of the infant's head and mild systemic hypothermia 17/118 (14%) with normothermia |
RR 1.30 95% CI 0.73 to 2.34 |
Not significant | |
RCT |
234 newborn infants with clinical and electroencephalographic evidence of moderate or severe hypoxic–ischaemic encephalopathy |
Renal impairment
73/112 (65%) with therapeutic cooling of the infant's head and mild systemic hypothermia 83/118 (70%) with normothermia |
RR 0.93 95% CI 0.77 to 1.11 |
Not significant | |
RCT |
234 newborn infants with clinical and electroencephalographic evidence of moderate or severe hypoxic–ischaemic encephalopathy |
Hypoglycaemia
14/112 (13%) with therapeutic cooling of the infant's head and mild systemic hypothermia 20/118 (17%) with normothermia |
RR 0.74 95% CI 0.39 to 1.39 |
Not significant | |
RCT |
208 term or near-term infants with moderate/severe neonatal encephalopathy after perinatal asphyxia |
Hypotension treated with vasopressors
42/112 (38%) with whole-body cooling 35/118 (30%) with normothermia |
RR 1.26 95% CI 0.88 to 1.82 |
Not significant | |
RCT |
208 term or near-term infants with moderate/severe neonatal encephalopathy after perinatal asphyxia |
Cardiac arrhythmia
2/112 (2%) with whole-body cooling 1/118 (1%) with normothermia |
RR 2.11 95% CI 0.19 to 22.9 |
Not significant | |
RCT |
208 term or near-term infants with moderate/severe neonatal encephalopathy after perinatal asphyxia |
Persistent pulmonary hypertension
25/112 (22%) with whole-body cooling 23/118 (19%) with normothermia |
RR 1.15 95% CI 0.69 to 1.90 |
Not significant | |
RCT |
208 term or near-term infants with moderate/severe neonatal encephalopathy after perinatal asphyxia |
Renal impairment
22/112 (20%) with whole-body cooling 27/118 (23%) with normothermia |
RR 0.86 95% CI 0.52 to 1.42 |
Not significant | |
RCT |
208 term or near-term infants with moderate/severe neonatal encephalopathy after perinatal asphyxia |
Hypoglycaemia
12/112 (11%) with whole-body cooling 16/118 (14%) with normothermia |
RR 0.79 95% CI 0.39 to 1.60 |
Not significant | |
RCT |
208 term or near-term infants with moderate/severe neonatal encephalopathy after perinatal asphyxia |
Hypocalcaemia
28/112 (25%) with whole-body cooling 20/118 (17%) with normothermia |
RR 1.47 95% CI 0.88 to 2.46 |
Not significant | |
RCT |
208 term or near-term infants with moderate/severe neonatal encephalopathy after perinatal asphyxia |
Hepatic dysfunction
20/112 (18%) with whole-body cooling 16/118 (14%) with normothermia |
RR 1.32 95% CI 0.72 to 2.41 |
Not significant | |
RCT |
208 term or near-term infants with moderate/severe neonatal encephalopathy after perinatal asphyxia |
Disseminated intravascular coagulopathy
18/112 (16%) with whole-body cooling 12/118 (10%) with normothermia |
RR 1.58 95% CI 0.80 to 3.13 |
Not significant |