NeoNotes Journal Club
Andrew B. Kairalla MD, Editor
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Cool Cap Trial, presented by John Wyatt MD,
One hundred seventy-nine infants with moderate to severe HIE were recruited
from 28 perinatal centers and randomly assigned to head cooling or control
groups. The eligibility criteria
included pH < 7.0, Apgar < 5 at 10 minutes, and an abnormal
amplitude-integrated EEG. The head
cooling was initiated within 5.5 hours of birth, and was regulated to achieve a
rectal temperature of 34.5C for 72 hours. Sinus
bradycardia was consistently seen during cooling.
There was no increase in rates of major adverse events, acute mortality,
or the incidence of severity of complications between groups.
No outcome data has been analyzed yet.
Chinese Trial, presented by Bo Sun MD, Children’s
Hospital, Fudan University, Shanghai,
This was another trial of selective head cooling for severe HIE.
Eighty-eight term babies with HIE were randomly assigned to hypothermia
or control group. Entry criteria and treatment regimen were similar to the Cool
Cap study. Bradycardia (HR 100-110)
was common during hypothermia. No
other adverse effects were noted.
These trials looked at using whole body hypothermia for HIE rather than
selective head cooling. Otherwise,
the entry criteria and the duration/degree of cooling were similar.
Only pilot study results were reported, and no significant adverse
effects of hypothermia were noted. Multicenter
randomized controlled trials are in progress.
Comment. If
these studies confirm a benefit to hypothermia for HIE, then the next step
will be to determine the optimal route, temperature and duration of therapy.
The mechanism of action for this treatment also needs to be studied.
ABK
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