Browsing by Author "Maitre, Nathalie"

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    Association of EEG Background and Neurodevelopmental Outcome in Neonates With Hypoxic-Ischemic Encephalopathy Receiving Hypothermia
    (Wolters Kluwer, 2023-11-27) Glass, Hannah C.; Numis, Adam L.; Comstock, Bryan A.; Gonzalez, Fernando F.; Mietzsch, Ulrike; Bonifacio, Sonia Lomeli; Massey, Shavonne; Thomas, Cameron; Natarajan, Niranjana; Mayock, Dennis E.; Sokol, Gregory M.; Van Meurs, Krisa P.; Ahmad, Kaashif A.; Maitre, Nathalie; Heagerty, Patrick J.; Juul, Sandra E.; Wu, Yvonne W.; Wusthoff, Courtney J.; Pediatrics, School of Medicine
    Background and objectives: Predicting neurodevelopmental outcome for neonates with hypoxic-ischemic encephalopathy (HIE) is important for clinical decision-making, care planning, and parent communication. We examined the relationship between EEG background and neurodevelopmental outcome among children enrolled in a trial of erythropoietin or placebo for neonates with HIE treated with therapeutic hypothermia. Methods: Participants had EEG recorded throughout hypothermia. EEG background was classified as normal, discontinuous, or severely abnormal (defined as burst suppression, low voltage suppressed, or status epilepticus) at 5 1-hour epochs: onset of recording, 24, 36, 48, and 72 hours after birth. The predominant background pattern during the entire continuous video EEG monitoring recording was calculated using the arithmetic mean of the 5 EEG background ratings (normal = 0; discontinuous = 1; severely abnormal = 2) as follows: "predominantly normal" (mean = 0), "normal/discontinuous" (0 < mean<1), "predominantly discontinuous" (mean = 1), "discontinuous/severely abnormal" (1 < mean<2), or "predominantly severely abnormal" (mean = 2). Primary outcome was death or neurodevelopmental impairment (NDI) defined as cerebral palsy, Gross Motor Function Classification Score ≥1, or cognitive score <90 on Bayley Scales of Infant Toddler Development, third edition at age 2 years. Neurodevelopment was also categorized into a 5-level ordinal measure: no, mild, moderate, severe NDI, or death for secondary analysis. We used generalized linear regression models with robust standard errors to assess the relative risk of death or NDI by EEG background in both unadjusted and adjusted analyses controlling for the effects of treatment group, sex, HIE severity, and study recruitment site. Results: Among 142 neonates, the predominant background EEG pattern was predominantly normal in 35 (25%), normal/discontinuous in 68 (48%), predominantly discontinuous in 11 (7.7%), discontinuous/severely abnormal in 16 (11%), and predominantly severely abnormal in 12 (8.5%). Increasing severity of background across monitoring epochs was associated with increasingly worse clinical outcomes. Children with severe EEG background abnormality at any time point (n = 36, 25%) were significantly more likely to die or have severe NDI at 2 years (adjusted relative risk: 7.95, 95% CI 3.49-18.12). Discussion: EEG background is strongly associated with NDI at age 2 years. These results can be used to assist health care providers to plan follow-up care and counsel families for decision-making related to goals of care.
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    Risk of seizures in neonates with hypoxic-ischemic encephalopathy receiving hypothermia plus erythropoietin or placebo
    (Springer Nature, 2023) Glass, Hannah C.; Wusthoff, Courtney J.; Comstock, Bryan A.; Numis, Adam L.; Gonzalez, Fernando F.; Maitre, Nathalie; Massey, Shavonne L.; Mayock, Dennis E.; Mietzsch, Ulrike; Natarajan, Niranjana; Sokol, Gregory M.; Bonifacio, Sonia L.; Van Meurs, Krisa P.; Thomas, Cameron; Ahmad, Kaashif A.; Heagerty, Patrick J.; Juul, Sandra E.; Wu, Yvonne W.; Pediatrics, School of Medicine
    Background: An ancillary study of the High-Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial for neonates with hypoxic-ischemic encephalopathy (HIE) and treated with therapeutic hypothermia examined the hypothesis that neonates randomized to receive erythropoietin (Epo) would have a lower seizure risk and burden compared with neonates who received placebo. Methods: Electroencephalograms (EEGs) from 7/17 HEAL trial centers were reviewed. Seizure presence was compared across treatment groups using a logistic regression model adjusting for treatment, HIE severity, center, and seizure burden prior to the first dose. Among neonates with seizures, differences across treatment groups in median maximal hourly seizure burden were assessed using adjusted quantile regression models. Results: Forty-six of 150 (31%) neonates had EEG seizures (31% in Epo vs 30% in placebo, p = 0.96). Maximal hourly seizure burden after the study drug was not significantly different between groups (median 11.4 for Epo, IQR: 5.6, 18.1 vs median 9.7, IQR: 4.9, 21.0 min/h for placebo). Conclusion: In neonates with HIE treated with hypothermia who were randomized to Epo or placebo, we found no meaningful between-group difference in seizure risk or burden. These findings are consistent with overall trial results, which do not support Epo use for neonates with HIE undergoing therapeutic hypothermia. Impact: In the HEAL trial of erythropoietin (Epo) vs placebo for neonates with encephalopathy presumed due to hypoxic-ischemic encephalopathy (HIE) who were also treated with therapeutic hypothermia, electrographic seizures were detected in 31%, which is lower than most prior studies. Epo did not reduce the proportion of neonates with acute provoked seizures (31% in Epo vs 30% in placebo) or maximal hourly seizure burden after the study drug (median 11.4, IQR 5.6, 18.1 for Epo vs median 9.7, IQR 4.9, 21.0 min/h for placebo). There was no anti- or pro-convulsant effect of Epo when combined with therapeutic hypothermia for HIE.
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    The american pediatric society and society for pediatric research joint statement against racism and social injustice
    (Springer Nature, 2022) Abman, Steven H.; Armstrong, Sarah; Baker, Susan; Bogue, Clifford W.; Carlo, Waldemar; Chalak, Lina; Daniels, Stephen R.; Davis, Stephanie; Debaun, Michael R.; Fike, Candice; Frazer, Lauren; Gibson, Keisha; Gill, Michelle; Glass, Hannah; Gordon, Catherine M.; Goyal, Monika; Hirschhorn, Joel; Holtz, Lori; Hunstad, David A.; Leonard, Mary B.; Maitre, Nathalie; Markham, Larry; McAllister-Lucas, Linda; Orange, Jordan; Shah, Prachi; Simon, Tamara; Steinhorn, Robin H.; Tarini, Beth; Walker-Harding, Leslie R.; Pediatrics, School of Medicine