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Limited resource induced hypothermia

Question Type:
Intervention
Full Question:
For term infants with moderate/severe hypoxic ischemic encephalopathy managed in resource limited countries (P), does therapeutic hypothermia to core temperature of ~33.5C for 72 hours delivered by passive hypothermia and/or ice packs (I), compared with standard care (C), change improved rates of death; neurodevelopmental impairments at 18 months-2 years  (O)?
Consensus on Science:
For the critical outcome of death or disability, we identified very-low-quality evidence (downgraded for risk of bias and indirectness) from 2 randomized controlled trials (Jacobs 2011, 692; Bharadwaj 2012, 382) enrolling 338 infants showing benefit to the use of therapeutic hypothermia (OR, 0.43; 95% CI, 0.26–0.7). For the critical outcome of death to latest follow-up, we identified very-low-quality evidence (downgraded for risk of bias, inconsistency, and indirectness) from 4 randomized controlled trials (Jacobs 2011, 692; Robertson 2011, 138; Bharadwaj 2012, 382; Thayyil 2013, F280) enrolling 416 infants showing no benefit to the use of therapeutic hypothermia (OR, 0.72; 95% CI, 0.44–1.16).
Treatment Recommendation:
We suggest that newly born infants at term or near-term with evolving moderate-to-severe hypoxic-ischemic encephalopathy in low-income countries and/or other settings with limited resources may be treated with therapeutic hypothermia (weak recommendation, low-quality evidence).Cooling should only be considered, initiated, and conducted under clearly defined protocols with treatment in neonatal care facilities with the capabilities for multidisciplinary care and availability of adequate resources to offer intravenous therapy, respiratory support, pulse oximetry, antibiotics, anticonvulsants, and pathology testing. Treatment should be consistent with the protocols used in the randomized clinical trials in developed countries, ie, cooling to commence within 6 hours, strict temperature control at 33°C to 34°C for 72 hours and rewarm over at least 4 hours.Values, Preferences, and Task Force InsightsIn making this recommendation, we place a higher value on the demonstrated effectiveness of simple cooling methods and the lack of harm associated with these methods over the paucity of evidence specific to resource-limited settings. It is difficult to define a low-resource setting. Even within a country (eg, India) resources may vary widely. Simple methods of cooling are successful in lowering body temperature. There was a concern that passive cooling may not be so harmless (eg, extreme hypothermia, inappropriate hypothermia). Low-resource areas do not have nursing care to monitor the babies closely.
CoSTR Attachments:
Cooling death.pdf    
Cooling for HIE in resource limited settings Grade evidence profile_n.docx    
GRADE GRID cooling in resource poor settings_n.docx    
NRP 734 Cooling death or disability.pdf    

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