Browsing by Subject "hypothermia"

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    Effect of Depth and Duration of Cooling on Death or Disability at Age 18 Months Among Neonates With Hypoxic-Ischemic Encephalopathy: A Randomized Clinical Trial
    (AMA, 2017-07) Shankaran, Seetha; Laptook, Abbot R.; Pappas, Athina; McDonald, Scott A.; Das, Abhik; Tyson, Jon E.; Poindexter, Brenda B.; Schibler, Kurt; Bell, Edward F.; Heyne, Roy J.; Pedroza, Claudia; Bara, Rebecca; Van Meurs, Krisa P.; Huitema, Carolyn M. Petrie; Grisby, Cathy; Devaskar, Uday; Ehrenkranz, Richard A.; Harmon, Heidi M.; Chalak, Lina F.; DeMauro, Sara B.; Garg, Meena; Hartley-McAndrew, Michelle E.; Khan, Amir M.; Walsh, Michele C.; Ambalavanan, Namasivayam; Brumbaugh, Jane E.; Watterberg, Kristi L.; Shepherd, Edward G.; Hamrick, Shannon E. G.; Barks, John; Cotten, C. Michael; Kilbride, Howard W.; Higgins, Rosemary D.; Pediatrics, School of Medicine
    Importance Hypothermia for 72 hours at 33.5°C for neonatal hypoxic-ischemic encephalopathy reduces death or disability, but rates continue to be high. Objective To determine if cooling for 120 hours or to a temperature of 32.0°C reduces death or disability at age 18 months in infants with hypoxic-ischemic encephalopathy. Design, Setting, and Participants Randomized 2 × 2 factorial clinical trial in neonates (≥36 weeks’ gestation) with hypoxic-ischemic encephalopathy at 18 US centers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network between October 2010 and January 2016. Interventions A total of 364 neonates were randomly assigned to 4 hypothermia groups: 33.5°C for 72 hours (n = 95), 32.0°C for 72 hours (n = 90), 33.5°C for 120 hours (n = 96), or 32.0°C for 120 hours (n = 83). Main Outcomes and Measures The primary outcome was death or moderate or severe disability at 18 to 22 months of age adjusted for center and level of encephalopathy. Severe disability included any of Bayley Scales of Infant Development III cognitive score less than 70, Gross Motor Function Classification System (GMFCS) level of 3 to 5, or blindness or hearing loss despite amplification. Moderate disability was defined as a cognitive score of 70 to 84 and either GMFCS level 2, active seizures, or hearing with amplification. Results The trial was stopped for safety and futility in November 2013 after 364 of the planned 726 infants were enrolled. Among 347 infants (95%) with primary outcome data (mean age at follow-up, 20.7 [SD, 3.5] months; 42% female), death or disability occurred in 56 of 176 (31.8%) cooled for 72 hours and 54 of 171 (31.6%) cooled for 120 hours (adjusted risk ratio, 0.92 [95% CI, 0.68-1.25]; adjusted absolute risk difference, −1.0% [95% CI, −10.2% to 8.1%]) and in 59 of 185 (31.9%) cooled to 33.5°C and 51 of 162 (31.5%) cooled to 32.0°C (adjusted risk ratio, 0.92 [95% CI, 0.68-1.26]; adjusted absolute risk difference, −3.1% [95% CI, −12.3% to 6.1%]). A significant interaction between longer and deeper cooling was observed (P = .048), with primary outcome rates of 29.3% at 33.5°C for 72 hours, 34.5% at 32.0°C for 72 hours, 34.4% at 33.5°C for 120 hours, and 28.2% at 32.0°C for 120 hours. Conclusions and Relevance Among term neonates with moderate or severe hypoxic-ischemic encephalopathy, cooling for longer than 72 hours, cooling to lower than 33.5°C, or both did not reduce death or moderate or severe disability at 18 months of age. However, the trial may be underpowered, and an interaction was found between longer and deeper cooling. These results support the current regimen of cooling for 72 hours at 33.5°C.
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    Hypothermia is Associated With Poor Prognosis in Hospitalized Patients With Severe COVID-19 Symptoms
    (2021) Maait, Yousef; El Khoury, Marc; McKinley, Lee; El Khoury, Anthony; Graduate Medical Education, Office of Educational Affairs, IU School of Medicine
    Rationale Hypothermia forms a part of the diagnostic criteria for Systemic Inflammatory Response Syndrome (SIRS), National Early Warning Score (NEWS) and has repeatedly been shown to be associated with worse outcomes when compared to normothermic and hyperthermic patients with sepsis. We evaluate whether this is the case in COVID-19 patients. Objective To determine whether there is an association between hypothermia and worse prognosis in COVID-19 patients in the intensive care unit. Methods Retrospective study of a cohort of patients (n = 57) admitted to the intensive care unit of a community hospital with a positive test for COVID-19. Measurements Data relating to mortality, comorbidities and length of stay was recorded from electronic medical records for each patient. Hypothermia was defined as ≥2 recorded body temperatures of less than 96.5℉ (35.83℃) at the time of admission. Main results Of the 57 patients enrolled in the study, 21 developed hypothermia during their stay and 36 did not. Our results show that patients who have hypothermia at the time of admission spend a longer time intubated (p < 0.01) and go through longer ICU stays (p < 0.01). These patients are also 2.18 times more likely to suffer a fatal outcome compared to patients that did not develop hypothermia while in the intensive care unit (Chi-squared = 8.6209, p < 0.01, RR = 2.18). Conclusions Hypothermia in patients with severe COVID-19 at the time of admission to the ICU is associated with poorer outcomes for patients. This manifests as a longer period of intubation, longer ICU stay, and increased risk of mortality.
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    The NeoWarm biomedical device: Assessment of feasibility and cultural acceptability, identification of potential barriers and challenges, and stakeholder mapping
    (Office of the Vice Chancellor for Research, 2016-04-08) Watts, Thomasina; Siddiki, Furhan; Savita, Aakash
    Introduction: Across the globe, approximately 4 million newborns die each year; complications from hypothermia underlie many of these deaths. Regions with fewer resources for neonatal care have higher rates of hypothermia­related death. Kangaroo Mother Care (KMC) is the practice of prolonged skin­to­skin contact to prevent hypothermia among small and premature infants. KMC is cost effective, and proven to reduce hypothermia; however, KMC programs are often discontinued or fail to expand. A built prototype of a biomedical device, called NeoWarm, has been developed to augment KMC initiatives. Identification of potential barriers and facilitators to adoption the NeoWarm technology is urgently needed. Methods: In order to assess the feasibility of NeoWarm, and to identify current barriers to implementation of KMC and NeoWarm, a comprehensive literature review was conducted. Key barriers and facilitators to existing KMC programs in sub­Saharan Africa, Asia, and Latin America were identified. Stakeholder mapping and analysis in relation to the NeoWarm device for three “target countries” within each of these global regions was performed. Potential stakeholders were identified and categorically ranked in terms of influence and relevance. Results: Three key barriers to KMC programs were identified. These included: unacceptability among male stakeholders; lack of support from health care providers and insufficient health infrastructure, leading to fears of tuberculosis and other infections spreading in crowded KMC wards. Comprehensive stakeholder mapping for Kenya, India, and Guatemala revealed a complex web of potential influencers and regulatory processes for adoption of NeoWarm technology. Conclusion: The NeoWarm device may support increased acceptance of KMC among male stakeholders and some health care providers; however, the concerns regarding spread of tuberculosis among KMC mother­baby pairs was an unexpected finding, which will significantly inform subsequent NeoWarm development and testing. Stakeholder mapping and analysis revealed many potential NeoWarm partners within each region whom had not been previously identified.