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Differences in Patient Characteristics and Care Practices between Two Trials of Therapeutic Hypothermia

BACKGROUND: The Induced Hypothermia (IH) and Optimizing Cooling (OC),trials for HIE had similar inclusion criteria. The rate of death/moderate-severe disability differed for the subgroups treated with TH at 33.5°C for 72 hours (44% vs. 29%, unadjusted p=0.03). We aimed to evaluate differences in pat...

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Autores principales: Bonifacio, Sonia L., McDonald, Scott A., Chock, Valerie Y., Wusthoff, Courtney J., Hintz, Susan R., Laptook, Abbot R., Shankara, Seetha, Van Meurs, Krisa P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6857796/
https://www.ncbi.nlm.nih.gov/pubmed/30862961
http://dx.doi.org/10.1038/s41390-019-0371-2
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author Bonifacio, Sonia L.
McDonald, Scott A.
Chock, Valerie Y.
Wusthoff, Courtney J.
Hintz, Susan R.
Laptook, Abbot R.
Shankara, Seetha
Van Meurs, Krisa P.
author_facet Bonifacio, Sonia L.
McDonald, Scott A.
Chock, Valerie Y.
Wusthoff, Courtney J.
Hintz, Susan R.
Laptook, Abbot R.
Shankara, Seetha
Van Meurs, Krisa P.
author_sort Bonifacio, Sonia L.
collection PubMed
description BACKGROUND: The Induced Hypothermia (IH) and Optimizing Cooling (OC),trials for HIE had similar inclusion criteria. The rate of death/moderate-severe disability differed for the subgroups treated with TH at 33.5°C for 72 hours (44% vs. 29%, unadjusted p=0.03). We aimed to evaluate differences in patient characteristics and care practices between the trials. METHODS: We compared pre/post-randomization characteristics and care practices between IH and OC. RESULTS: There were 208 patients in the IH trial, 102 cooled, and 364 in the OC trial, 95 cooled to 33.5°C for 72 hours. In OC, neonates were less ill, fewer had severe HIE, and the majority were cooled prior to randomization. Differences between IH and OC were observed in the adjusted difference in the lowest PCO2 (+3.08mmHG, p=0.005) and highest PO2 (−82.7 mmHG, p<0.001). In OC compared to IH the adjusted RR of exposure to anticonvulsant prior to randomization was decreased (RR 0.58, (0.40-0.85), p=0.005) and there was increased risk of exposure during cooling to sedatives/analgesia (RR1.86 (1.21-2.86), p=0.005). CONCLUSION: Despite similar inclusion criteria, there were differences in patient characteristics and care practices between trials. Change in care practices over time should be considered when planning future neuroprotective trials.
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spelling pubmed-68577962019-11-16 Differences in Patient Characteristics and Care Practices between Two Trials of Therapeutic Hypothermia Bonifacio, Sonia L. McDonald, Scott A. Chock, Valerie Y. Wusthoff, Courtney J. Hintz, Susan R. Laptook, Abbot R. Shankara, Seetha Van Meurs, Krisa P. Pediatr Res Article BACKGROUND: The Induced Hypothermia (IH) and Optimizing Cooling (OC),trials for HIE had similar inclusion criteria. The rate of death/moderate-severe disability differed for the subgroups treated with TH at 33.5°C for 72 hours (44% vs. 29%, unadjusted p=0.03). We aimed to evaluate differences in patient characteristics and care practices between the trials. METHODS: We compared pre/post-randomization characteristics and care practices between IH and OC. RESULTS: There were 208 patients in the IH trial, 102 cooled, and 364 in the OC trial, 95 cooled to 33.5°C for 72 hours. In OC, neonates were less ill, fewer had severe HIE, and the majority were cooled prior to randomization. Differences between IH and OC were observed in the adjusted difference in the lowest PCO2 (+3.08mmHG, p=0.005) and highest PO2 (−82.7 mmHG, p<0.001). In OC compared to IH the adjusted RR of exposure to anticonvulsant prior to randomization was decreased (RR 0.58, (0.40-0.85), p=0.005) and there was increased risk of exposure during cooling to sedatives/analgesia (RR1.86 (1.21-2.86), p=0.005). CONCLUSION: Despite similar inclusion criteria, there were differences in patient characteristics and care practices between trials. Change in care practices over time should be considered when planning future neuroprotective trials. 2019-03-12 2019-06 /pmc/articles/PMC6857796/ /pubmed/30862961 http://dx.doi.org/10.1038/s41390-019-0371-2 Text en http://www.nature.com/authors/editorial_policies/license.html#terms Users may view, print, copy, and download text and data-mine the content in such documents, for the purposes of academic research, subject always to the full Conditions of use:http://www.nature.com/authors/editorial_policies/license.html#terms
spellingShingle Article
Bonifacio, Sonia L.
McDonald, Scott A.
Chock, Valerie Y.
Wusthoff, Courtney J.
Hintz, Susan R.
Laptook, Abbot R.
Shankara, Seetha
Van Meurs, Krisa P.
Differences in Patient Characteristics and Care Practices between Two Trials of Therapeutic Hypothermia
title Differences in Patient Characteristics and Care Practices between Two Trials of Therapeutic Hypothermia
title_full Differences in Patient Characteristics and Care Practices between Two Trials of Therapeutic Hypothermia
title_fullStr Differences in Patient Characteristics and Care Practices between Two Trials of Therapeutic Hypothermia
title_full_unstemmed Differences in Patient Characteristics and Care Practices between Two Trials of Therapeutic Hypothermia
title_short Differences in Patient Characteristics and Care Practices between Two Trials of Therapeutic Hypothermia
title_sort differences in patient characteristics and care practices between two trials of therapeutic hypothermia
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6857796/
https://www.ncbi.nlm.nih.gov/pubmed/30862961
http://dx.doi.org/10.1038/s41390-019-0371-2
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