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. Author manuscript; available in PMC: 2014 Sep 24.
Published in final edited form as: Curr Mol Med. 2012 Dec;12(10):1282–1296. doi: 10.2174/156652412803833517

Table 2.

Randomized Controlled Clinical Trials on Hypothermia for the Management of Neonatal HIE

Injury
Types
No. of
Patients
Inclusion Criteria Hypother
mia (°C)
Cooling
Method
Cooling
Length
(Hour)
Follow-
Up
(Month)
Neurological
Outcome
Refs.
HIE 22 Gestational age (GA) > 37 weeks,
defined criteria for low Apgar
scores, low arterial cord pH and
clinical signs of encephalopathy
36.5-36
and
35.9-35.5
Selective
head
72 3, 6, 12 Established the
safety of mild
hypothermia
[78]
HIE 208 GA > 36 weeks, seizures or
moderate encephalopathy with
defined criteria for low cord or
arterial pH, increased base deficit
and low Apgar scores
33.5 Whole
body
72 18–22 Significant
reduction in the
risk of death or
moderate to
severe
neurodevelopment
al disability in
hypothermia
group
[92]
HIE 65 GA > 35 weeks, Birth weight >
2000g with defined criteria for low
cord or infant gas pH, low Apgar
scores, increased need for
resuscitation and signs of neonatal
encephalopathy
33 ± 0.5 Whole
body
48 12 Significant
reduction in
severely abnormal
motor scores and
combined
outcome of death
or severe motor
scores in the
hypothermia
group
[93]
HIE 218 GA > 36 weeks with defined
criteria for low Apgar scores,
increased need for resuscitation,
low cord blood or infant blood pH
and amplitude integrated EEG
(aEEG) suggestive of moderate to
severe encephalopathy
34–35 Selective
head
72 18 Reduction in
death or severe
disability at 18
months in
hypothermia
group
[91]
HIE 325 GA > 36 weeks with defined
criteria for low Apgar scores,
increased need for resuscitation,
low cord or infant blood pH,
moderate to severe
encephalopathy and an abnormal
aEEG
33–34 Whole
body
72 18 Significant
increase in rate of
survival without
neurologic
abnormality and
reduced risks of
cerebral palsy
among survivors
in cooled group
[94]

Explanation of abbreviations can be found in the list of abbreviations.