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Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial.

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Title: Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial.
Authors: Gluckman PD (AUTHOR), Wyatt JS (AUTHOR), Azzopardi D (AUTHOR), Ballard R (AUTHOR), Edwards AD (AUTHOR), Ferriero DM (AUTHOR), Polin RA (AUTHOR), Robertson CM (AUTHOR), Thoresen M (AUTHOR), Whitelaw A (AUTHOR), Gunn AJ (AUTHOR), CoolCap Study Group (CORPORATE AUTHOR), Gluckman, Peter D (AUTHOR), Wyatt, John S (AUTHOR), Azzopardi, Denis (AUTHOR), Ballard, Roberta (AUTHOR), Edwards, A David (AUTHOR), Ferriero, Donna M (AUTHOR), Polin, Richard A (AUTHOR), Robertson, Charlene M (AUTHOR)
Source: Lancet. 2/19/2005, Vol. 365 Issue 9460, p663-670. 8p.
Abstract: Background: Cerebral hypothermia can improve outcome of experimental perinatal hypoxia-ischaemia. We did a multicentre randomised controlled trial to find out if delayed head cooling can improve neurodevelopmental outcome in babies with neonatal encephalopathy.Methods: 234 term infants with moderate to severe neonatal encephalopathy and abnormal amplitude integrated electroencephalography (aEEG) were randomly assigned to either head cooling for 72 h, within 6 h of birth, with rectal temperature maintained at 34-35 degrees C (n=116), or conventional care (n=118). Primary outcome was death or severe disability at 18 months. Analysis was by intention to treat. We examined in two predefined subgroup analyses the effect of hypothermia in babies with the most severe aEEG changes before randomisation--ie, severe loss of background amplitude, and seizures--and those with less severe changes.Findings: In 16 babies, follow-up data were not available. Thus in 218 infants (93%), 73/110 (66%) allocated conventional care and 59/108 (55%) assigned head cooling died or had severe disability at 18 months (odds ratio 0.61; 95% CI 0.34-1.09, p=0.1). After adjustment for the severity of aEEG changes with a logistic regression model, the odds ratio for hypothermia treatment was 0.57 (0.32-1.01, p=0.05). No difference was noted in the frequency of clinically important complications. Predefined subgroup analysis suggested that head cooling had no effect in infants with the most severe aEEG changes (n=46, 1.8; 0.49-6.4, p=0.51), but was beneficial in infants with less severe aEEG changes (n=172, 0.42; 0.22-0.80, p=0.009).Interpretation: These data suggest that although induced head cooling is not protective in a mixed population of infants with neonatal encephalopathy, it could safely improve survival without severe neurodevelopmental disability in infants with less severe aEEG changes. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial.
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  Data: <searchLink fieldCode="AR" term="%22Gluckman+PD%22">Gluckman PD</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wyatt+JS%22">Wyatt JS</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Azzopardi+D%22">Azzopardi D</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ballard+R%22">Ballard R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Edwards+AD%22">Edwards AD</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ferriero+DM%22">Ferriero DM</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Polin+RA%22">Polin RA</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Robertson+CM%22">Robertson CM</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Thoresen+M%22">Thoresen M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Whitelaw+A%22">Whitelaw A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gunn+AJ%22">Gunn AJ</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22CoolCap+Study+Group%22">CoolCap Study Group</searchLink> (CORPORATE AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gluckman%2C+Peter+D%22">Gluckman, Peter D</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wyatt%2C+John+S%22">Wyatt, John S</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Azzopardi%2C+Denis%22">Azzopardi, Denis</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ballard%2C+Roberta%22">Ballard, Roberta</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Edwards%2C+A+David%22">Edwards, A David</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ferriero%2C+Donna+M%22">Ferriero, Donna M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Polin%2C+Richard+A%22">Polin, Richard A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Robertson%2C+Charlene+M%22">Robertson, Charlene M</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 2/19/2005, Vol. 365 Issue 9460, p663-670. 8p.
– Name: Abstract
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  Data: <bold>Background: </bold>Cerebral hypothermia can improve outcome of experimental perinatal hypoxia-ischaemia. We did a multicentre randomised controlled trial to find out if delayed head cooling can improve neurodevelopmental outcome in babies with neonatal encephalopathy.<bold>Methods: </bold>234 term infants with moderate to severe neonatal encephalopathy and abnormal amplitude integrated electroencephalography (aEEG) were randomly assigned to either head cooling for 72 h, within 6 h of birth, with rectal temperature maintained at 34-35 degrees C (n=116), or conventional care (n=118). Primary outcome was death or severe disability at 18 months. Analysis was by intention to treat. We examined in two predefined subgroup analyses the effect of hypothermia in babies with the most severe aEEG changes before randomisation--ie, severe loss of background amplitude, and seizures--and those with less severe changes.<bold>Findings: </bold>In 16 babies, follow-up data were not available. Thus in 218 infants (93%), 73/110 (66%) allocated conventional care and 59/108 (55%) assigned head cooling died or had severe disability at 18 months (odds ratio 0.61; 95% CI 0.34-1.09, p=0.1). After adjustment for the severity of aEEG changes with a logistic regression model, the odds ratio for hypothermia treatment was 0.57 (0.32-1.01, p=0.05). No difference was noted in the frequency of clinically important complications. Predefined subgroup analysis suggested that head cooling had no effect in infants with the most severe aEEG changes (n=46, 1.8; 0.49-6.4, p=0.51), but was beneficial in infants with less severe aEEG changes (n=172, 0.42; 0.22-0.80, p=0.009).<bold>Interpretation: </bold>These data suggest that although induced head cooling is not protective in a mixed population of infants with neonatal encephalopathy, it could safely improve survival without severe neurodevelopmental disability in infants with less severe aEEG changes. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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