Whole-Body Hypothermia for Term and Near-Term Newborns With Hypoxic-Ischemic Encephalopathy

Abstract

Objective:To determine the effectiveness and safety of moderate whole-body hypothermia in newborns with hypoxic-ischemic encephalopathy born in hospitals with and without newborn intensive care facilities or complicated hypothermia equipment.Design: Multicenter, international, randomized controlled trial.Participants: Newborns of 35 weeks' gestation or more, with indicators of peripartum hypoxia-ischemia and moderate to severe clinical encephalopathy, randomly allocated to hypothermia (n=110) or standard care (n=111).Intervention: Whole-body hypothermia to 33.5°C for 72 hours or standard care (37°C). Infants who received hypothermia were treated at ambient environmental temperature by turning off the radiant warmer and then applying refrigerated gel packs to maintain rectal temperature at 33°C to 34°C.Main Outcome Measures: Death or major sensorineural disability at 2 years of age.Results: Therapeutic hypothermia reduced the risk of death or major sensorineural disability at 2 years of age: 55 of 107 infants (51.4%) in the hypothermia group and 67 of 101 infants (66.3%) in the control group died or had a major sensorineural disability at 2 years (risk ratio, 0.77 [95% confidence interval, 0.62-0.98]; P=.03). The mortality rate decreased, and the survival rate free of any sensorineural disability increased. Adverse effects of hypothermia were minimal.Conclusions: Whole-body hypothermia is effective and appears to be safe when commenced within 6 hours of birth at the hospital of birth in term and near-term newborns with hypoxic-ischemic encephalopathy. This simple method of hypothermia could be used within strict protocols with appropriate training on correct diagnosis and application of hypothermia in nontertiary neonatal settings while awaiting retrieval and transport to the regional neonatal intensive care unit.

Neurodevelopmental outcome following therapeutic hypothermia for perinatal asphyxia

“…Our mortality rate for the followed period, four out of 25 patients (16%), was comparable or lower than in most other studies (9)(10)(11)(12). From the available data, it is hard to comment on this, since there was no major diff erence in asphyxia severity, and our percentage can be part of a small number of patients we had in our group.…”

Part 13: Neonatal Resuscitation

“…Evidence suggests that use of therapeutic hypothermia in resource-limited settings (ie, lack of qualified staff, inadequate equipment, etc) may be considered and offered under clearly defined protocols similar to those used in published clinical trials and in facilities with the capabilities for multidisciplinary care and longitudinal follow-up [192][193][194][195] (Class IIb, LOE B-R).…”

Part 7: Neonatal Resuscitation

“…For the critical outcome of death to latest follow-up, we identified verylow-quality evidence (downgraded for risk of bias, inconsistency, and indirectness) from 4 randomized controlled trials [239][240][241][242] enrolling 416 infants showing no benefit to the use of therapeutic hypothermia (OR, 0.72; 95% CI, 0.44-1.16).…”