Childhood outcomes after hypothermia for neonatal encephalopathy

Seetha Shankaran, Athina Pappas, Scott A. McDonald, Betty R. Vohr, Susan R. Hintz, Kimberly Yolton, Kathryn E. Gustafson, Theresa M. Leach, Charles Green, Rebecca Bara, Carolyn M. Petrie Huitema, Richard A. Ehrenkranz, Jon E. Tyson, Abhik Das, Jane Hammond, Myriam Peralta-Carcelen, Patricia W. Evans, Roy J. Heyne, Deanne E. Wilson-Costello, Yvonne E. Vaucher & 7 others Charles R. Bauer, Anna M. Dusick, Ira Adams-Chapman, Ricki F. Goldstein, Ronnie Guillet, Lu Ann Papile, Rosemary D. Higgins

Research output: Contribution to journalArticle

345 Citations (Scopus)

Abstract

BACKGROUND: We previously reported early results of a randomized trial of whole-body hypothermia for neonatal hypoxic-ischemic encephalopathy showing a significant reduction in the rate of death or moderate or severe disability at 18 to 22 months of age. Long-term outcomes are now available. METHODS: In the original trial, we assigned infants with moderate or severe encephalopathy to usual care (the control group) or whole-body cooling to an esophageal temperature of 33.5°C for 72 hours, followed by slow rewarming (the hypothermia group). We evaluated cognitive, attention and executive, and visuospatial function; neurologic outcomes; and physical and psychosocial health among participants at 6 to 7 years of age. The primary outcome of the present analyses was death or an IQ score below 70. RESULTS: Of the 208 trial participants, primary outcome data were available for 190. Of the 97 children in the hypothermia group and the 93 children in the control group, death or an IQ score below 70 occurred in 46 (47%) and 58 (62%), respectively (P = 0.06); death occurred in 27 (28%) and 41 (44%) (P = 0.04); and death or severe disability occurred in 38 (41%) and 53 (60%) (P = 0.03). Other outcome data were available for the 122 surviving children, 70 in the hypothermia group and 52 in the control group. Moderate or severe disability occurred in 24 of 69 children (35%) and 19 of 50 children (38%), respectively (P = 0.87). Attention-executive dysfunction occurred in 4% and 13%, respectively, of children receiving hypothermia and those receiving usual care (P = 0.19), and visuospatial dysfunction occurred in 4% and 3% (P = 0.80). CONCLUSIONS: The rate of the combined end point of death or an IQ score of less than 70 at 6 to 7 years of age was lower among children undergoing whole-body hypothermia than among those undergoing usual care, but the differences were not significant. However, hypothermia resulted in lower death rates and did not increase rates of severe disability among survivors. (Funded by the National Institutes of Health and the Eunice Kennedy Shriver NICHD Neonatal Research Network; ClinicalTrials.gov number, NCT00005772.)

Original languageEnglish (US)
Pages (from-to)2085-2092
Number of pages8
JournalNew England Journal of Medicine
Volume366
Issue number22
DOIs
StatePublished - May 31 2012

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Brain Diseases
Hypothermia
Control Groups
National Institute of Child Health and Human Development (U.S.)
Brain Hypoxia-Ischemia
Rewarming
Mortality
Executive Function
National Institutes of Health (U.S.)
Nervous System
Survivors
Temperature
Health
Research

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Shankaran, S., Pappas, A., McDonald, S. A., Vohr, B. R., Hintz, S. R., Yolton, K., ... Higgins, R. D. (2012). Childhood outcomes after hypothermia for neonatal encephalopathy. New England Journal of Medicine, 366(22), 2085-2092. https://doi.org/10.1056/NEJMoa1112066

Childhood outcomes after hypothermia for neonatal encephalopathy. / Shankaran, Seetha; Pappas, Athina; McDonald, Scott A.; Vohr, Betty R.; Hintz, Susan R.; Yolton, Kimberly; Gustafson, Kathryn E.; Leach, Theresa M.; Green, Charles; Bara, Rebecca; Petrie Huitema, Carolyn M.; Ehrenkranz, Richard A.; Tyson, Jon E.; Das, Abhik; Hammond, Jane; Peralta-Carcelen, Myriam; Evans, Patricia W.; Heyne, Roy J.; Wilson-Costello, Deanne E.; Vaucher, Yvonne E.; Bauer, Charles R.; Dusick, Anna M.; Adams-Chapman, Ira; Goldstein, Ricki F.; Guillet, Ronnie; Papile, Lu Ann; Higgins, Rosemary D.

In: New England Journal of Medicine, Vol. 366, No. 22, 31.05.2012, p. 2085-2092.

Research output: Contribution to journalArticle

Shankaran, S, Pappas, A, McDonald, SA, Vohr, BR, Hintz, SR, Yolton, K, Gustafson, KE, Leach, TM, Green, C, Bara, R, Petrie Huitema, CM, Ehrenkranz, RA, Tyson, JE, Das, A, Hammond, J, Peralta-Carcelen, M, Evans, PW, Heyne, RJ, Wilson-Costello, DE, Vaucher, YE, Bauer, CR, Dusick, AM, Adams-Chapman, I, Goldstein, RF, Guillet, R, Papile, LA & Higgins, RD 2012, 'Childhood outcomes after hypothermia for neonatal encephalopathy', New England Journal of Medicine, vol. 366, no. 22, pp. 2085-2092. https://doi.org/10.1056/NEJMoa1112066
Shankaran S, Pappas A, McDonald SA, Vohr BR, Hintz SR, Yolton K et al. Childhood outcomes after hypothermia for neonatal encephalopathy. New England Journal of Medicine. 2012 May 31;366(22):2085-2092. https://doi.org/10.1056/NEJMoa1112066
Shankaran, Seetha ; Pappas, Athina ; McDonald, Scott A. ; Vohr, Betty R. ; Hintz, Susan R. ; Yolton, Kimberly ; Gustafson, Kathryn E. ; Leach, Theresa M. ; Green, Charles ; Bara, Rebecca ; Petrie Huitema, Carolyn M. ; Ehrenkranz, Richard A. ; Tyson, Jon E. ; Das, Abhik ; Hammond, Jane ; Peralta-Carcelen, Myriam ; Evans, Patricia W. ; Heyne, Roy J. ; Wilson-Costello, Deanne E. ; Vaucher, Yvonne E. ; Bauer, Charles R. ; Dusick, Anna M. ; Adams-Chapman, Ira ; Goldstein, Ricki F. ; Guillet, Ronnie ; Papile, Lu Ann ; Higgins, Rosemary D. / Childhood outcomes after hypothermia for neonatal encephalopathy. In: New England Journal of Medicine. 2012 ; Vol. 366, No. 22. pp. 2085-2092.
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abstract = "BACKGROUND: We previously reported early results of a randomized trial of whole-body hypothermia for neonatal hypoxic-ischemic encephalopathy showing a significant reduction in the rate of death or moderate or severe disability at 18 to 22 months of age. Long-term outcomes are now available. METHODS: In the original trial, we assigned infants with moderate or severe encephalopathy to usual care (the control group) or whole-body cooling to an esophageal temperature of 33.5°C for 72 hours, followed by slow rewarming (the hypothermia group). We evaluated cognitive, attention and executive, and visuospatial function; neurologic outcomes; and physical and psychosocial health among participants at 6 to 7 years of age. The primary outcome of the present analyses was death or an IQ score below 70. RESULTS: Of the 208 trial participants, primary outcome data were available for 190. Of the 97 children in the hypothermia group and the 93 children in the control group, death or an IQ score below 70 occurred in 46 (47{\%}) and 58 (62{\%}), respectively (P = 0.06); death occurred in 27 (28{\%}) and 41 (44{\%}) (P = 0.04); and death or severe disability occurred in 38 (41{\%}) and 53 (60{\%}) (P = 0.03). Other outcome data were available for the 122 surviving children, 70 in the hypothermia group and 52 in the control group. Moderate or severe disability occurred in 24 of 69 children (35{\%}) and 19 of 50 children (38{\%}), respectively (P = 0.87). Attention-executive dysfunction occurred in 4{\%} and 13{\%}, respectively, of children receiving hypothermia and those receiving usual care (P = 0.19), and visuospatial dysfunction occurred in 4{\%} and 3{\%} (P = 0.80). CONCLUSIONS: The rate of the combined end point of death or an IQ score of less than 70 at 6 to 7 years of age was lower among children undergoing whole-body hypothermia than among those undergoing usual care, but the differences were not significant. However, hypothermia resulted in lower death rates and did not increase rates of severe disability among survivors. (Funded by the National Institutes of Health and the Eunice Kennedy Shriver NICHD Neonatal Research Network; ClinicalTrials.gov number, NCT00005772.)",
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T1 - Childhood outcomes after hypothermia for neonatal encephalopathy

AU - Shankaran, Seetha

AU - Pappas, Athina

AU - McDonald, Scott A.

AU - Vohr, Betty R.

AU - Hintz, Susan R.

AU - Yolton, Kimberly

AU - Gustafson, Kathryn E.

AU - Leach, Theresa M.

AU - Green, Charles

AU - Bara, Rebecca

AU - Petrie Huitema, Carolyn M.

AU - Ehrenkranz, Richard A.

AU - Tyson, Jon E.

AU - Das, Abhik

AU - Hammond, Jane

AU - Peralta-Carcelen, Myriam

AU - Evans, Patricia W.

AU - Heyne, Roy J.

AU - Wilson-Costello, Deanne E.

AU - Vaucher, Yvonne E.

AU - Bauer, Charles R.

AU - Dusick, Anna M.

AU - Adams-Chapman, Ira

AU - Goldstein, Ricki F.

AU - Guillet, Ronnie

AU - Papile, Lu Ann

AU - Higgins, Rosemary D.

PY - 2012/5/31

Y1 - 2012/5/31

N2 - BACKGROUND: We previously reported early results of a randomized trial of whole-body hypothermia for neonatal hypoxic-ischemic encephalopathy showing a significant reduction in the rate of death or moderate or severe disability at 18 to 22 months of age. Long-term outcomes are now available. METHODS: In the original trial, we assigned infants with moderate or severe encephalopathy to usual care (the control group) or whole-body cooling to an esophageal temperature of 33.5°C for 72 hours, followed by slow rewarming (the hypothermia group). We evaluated cognitive, attention and executive, and visuospatial function; neurologic outcomes; and physical and psychosocial health among participants at 6 to 7 years of age. The primary outcome of the present analyses was death or an IQ score below 70. RESULTS: Of the 208 trial participants, primary outcome data were available for 190. Of the 97 children in the hypothermia group and the 93 children in the control group, death or an IQ score below 70 occurred in 46 (47%) and 58 (62%), respectively (P = 0.06); death occurred in 27 (28%) and 41 (44%) (P = 0.04); and death or severe disability occurred in 38 (41%) and 53 (60%) (P = 0.03). Other outcome data were available for the 122 surviving children, 70 in the hypothermia group and 52 in the control group. Moderate or severe disability occurred in 24 of 69 children (35%) and 19 of 50 children (38%), respectively (P = 0.87). Attention-executive dysfunction occurred in 4% and 13%, respectively, of children receiving hypothermia and those receiving usual care (P = 0.19), and visuospatial dysfunction occurred in 4% and 3% (P = 0.80). CONCLUSIONS: The rate of the combined end point of death or an IQ score of less than 70 at 6 to 7 years of age was lower among children undergoing whole-body hypothermia than among those undergoing usual care, but the differences were not significant. However, hypothermia resulted in lower death rates and did not increase rates of severe disability among survivors. (Funded by the National Institutes of Health and the Eunice Kennedy Shriver NICHD Neonatal Research Network; ClinicalTrials.gov number, NCT00005772.)

AB - BACKGROUND: We previously reported early results of a randomized trial of whole-body hypothermia for neonatal hypoxic-ischemic encephalopathy showing a significant reduction in the rate of death or moderate or severe disability at 18 to 22 months of age. Long-term outcomes are now available. METHODS: In the original trial, we assigned infants with moderate or severe encephalopathy to usual care (the control group) or whole-body cooling to an esophageal temperature of 33.5°C for 72 hours, followed by slow rewarming (the hypothermia group). We evaluated cognitive, attention and executive, and visuospatial function; neurologic outcomes; and physical and psychosocial health among participants at 6 to 7 years of age. The primary outcome of the present analyses was death or an IQ score below 70. RESULTS: Of the 208 trial participants, primary outcome data were available for 190. Of the 97 children in the hypothermia group and the 93 children in the control group, death or an IQ score below 70 occurred in 46 (47%) and 58 (62%), respectively (P = 0.06); death occurred in 27 (28%) and 41 (44%) (P = 0.04); and death or severe disability occurred in 38 (41%) and 53 (60%) (P = 0.03). Other outcome data were available for the 122 surviving children, 70 in the hypothermia group and 52 in the control group. Moderate or severe disability occurred in 24 of 69 children (35%) and 19 of 50 children (38%), respectively (P = 0.87). Attention-executive dysfunction occurred in 4% and 13%, respectively, of children receiving hypothermia and those receiving usual care (P = 0.19), and visuospatial dysfunction occurred in 4% and 3% (P = 0.80). CONCLUSIONS: The rate of the combined end point of death or an IQ score of less than 70 at 6 to 7 years of age was lower among children undergoing whole-body hypothermia than among those undergoing usual care, but the differences were not significant. However, hypothermia resulted in lower death rates and did not increase rates of severe disability among survivors. (Funded by the National Institutes of Health and the Eunice Kennedy Shriver NICHD Neonatal Research Network; ClinicalTrials.gov number, NCT00005772.)

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