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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...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
2019
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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. |
format | Online Article Text |
id | pubmed-6857796 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
record_format | MEDLINE/PubMed |
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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