Browsing by Author "Baserga, Mariana"

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    Tissue Oxygenation Changes After Transfusion and Outcomes in Preterm Infants: A Secondary Near-Infrared Spectroscopy Study of the Transfusion of Prematures Randomized Clinical Trial (TOP NIRS)
    (American Medical Association, 2023-09-05) Chock, Valerie Y.; Kirpalani, Haresh; Bell, Edward F.; Tan, Sylvia; Hintz, Susan R.; Ball, M. Bethany; Smith, Emily; Das, Abhik; Loggins, Yvonne C.; Sood, Beena G.; Chalak, Lina F.; Wyckoff, Myra H.; Kicklighter, Stephen D.; Kennedy, Kathleen A.; Patel, Ravi M.; Carlo, Waldemar A.; Johnson, Karen J.; Watterberg, Kristi L.; Sánchez, Pablo J.; Laptook, Abbot R.; Seabrook, Ruth B.; Cotten, C. Michael; Mancini, Toni; Sokol, Gregory M.; Ohls, Robin K.; Hibbs, Anna Maria; Poindexter, Brenda B.; Reynolds, Anne Marie; DeMauro, Sara B.; Chawla, Sanjay; Baserga, Mariana; Walsh, Michele C.; Higgins, Rosemary D.; Van Meurs, Krisa P.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network; Pediatrics, School of Medicine
    Importance: Preterm infants with varying degrees of anemia have different tissue oxygen saturation responses to red blood cell (RBC) transfusion, and low cerebral saturation may be associated with adverse outcomes. Objective: To determine whether RBC transfusion in preterm infants is associated with increases in cerebral and mesenteric tissue saturation (Csat and Msat, respectively) or decreases in cerebral and mesenteric fractional tissue oxygen extraction (cFTOE and mFTOE, respectively) and whether associations vary based on degree of anemia, and to investigate the association of Csat with death or neurodevelopmental impairment (NDI) at 22 to 26 months corrected age. Design, setting, and participants: This was a prospective observational secondary study conducted among a subset of infants between August 2015 and April 2017 in the Transfusion of Prematures (TOP) multicenter randomized clinical trial at 16 neonatal intensive care units of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Preterm neonates with gestational age 22 to 28 weeks and birth weight 1000 g or less were randomized to higher or lower hemoglobin thresholds for transfusion. Data were analyzed between October 2020 and May 2022. Interventions: Near-infrared spectroscopy monitoring of Csat and Msat. Main outcomes and measures: Primary outcomes were changes in Csat, Msat, cFTOE, and mFTOE after transfusion between hemoglobin threshold groups, adjusting for age at transfusion, gestational age, birth weight stratum, and center. Secondary outcome at 22 to 26 months was death or NDI defined as cognitive delay (Bayley Scales of Infant and Toddler Development-III score <85), cerebral palsy with Gross Motor Function Classification System level II or greater, or severe vision or hearing impairment. Results: A total of 179 infants (45 [44.6%] male) with mean (SD) gestational age 25.9 (1.5) weeks were enrolled, and valid data were captured from 101 infants during 237 transfusion events. Transfusion was associated with a significant increase in mean Csat of 4.8% (95% CI, 2.7%-6.9%) in the lower-hemoglobin threshold group compared to 2.7% (95% CI, 1.2%-4.2%) in the higher-hemoglobin threshold group, while mean Msat increased 6.7% (95% CI, 2.4%-11.0%) vs 5.6% (95% CI, 2.7%-8.5%). Mean cFTOE and mFTOE decreased in both groups to a similar extent. There was no significant change in peripheral oxygen saturation (SpO2) in either group (0.2% vs -0.2%). NDI or death occurred in 36 infants (37%). Number of transfusions with mean pretransfusion Csat less than 50% was associated with NDI or death (odds ratio, 2.41; 95% CI, 1.08-5.41; P = .03). Conclusions and relevance: In this secondary study of the TOP randomized clinical trial, Csat and Msat were increased after transfusion despite no change in SpO2. Lower pretransfusion Csat may be associated with adverse outcomes, supporting further investigation of targeted tissue saturation monitoring in preterm infants with anemia.
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    Trial of Erythropoietin for Hypoxic-Ischemic Encephalopathy in Newborns
    (Massachusetts Medical Society, 2022) Wu, Yvonne W.; Comstock, Bryan A.; Gonzalez, Fernando F.; Mayock, Dennis E.; Goodman, Amy M.; Maitre, Nathalie L.; Chang, Taeun; Van Meurs, Krisa P.; Lampland, Andrea L.; Bendel-Stenzel, Ellen; Mathur, Amit M.; Wu, Tai-Wei; Riley, David; Mietzsch, Ulrike; Chalak, Lina; Flibotte, John; Weitkamp, Joern-Hendrik; Ahmad, Kaashif A.; Yanowitz, Toby D.; Baserga, Mariana; Poindexter, Brenda B.; Rogers, Elizabeth E.; Lowe, Jean R.; Kuban, Karl C. K.; O'Shea, T. Michael; Wisnowski, Jessica L.; McKinstry, Robert C.; Bluml, Stefan; Bonifacio, Sonia; Benninger, Kristen L.; Rao, Rakesh; Smyser, Christopher D.; Sokol, Gregory M.; Merhar, Stephanie; Schreiber, Michael D.; Glass, Hannah C.; Heagerty, Patrick J.; Juul, Sandra E.; HEAL Consortium; Pediatrics, School of Medicine
    Background: Neonatal hypoxic-ischemic encephalopathy is an important cause of death as well as long-term disability in survivors. Erythropoietin has been hypothesized to have neuroprotective effects in infants with hypoxic-ischemic encephalopathy, but its effects on neurodevelopmental outcomes when given in conjunction with therapeutic hypothermia are unknown. Methods: In a multicenter, double-blind, randomized, placebo-controlled trial, we assigned 501 infants born at 36 weeks or more of gestation with moderate or severe hypoxic-ischemic encephalopathy to receive erythropoietin or placebo, in conjunction with standard therapeutic hypothermia. Erythropoietin (1000 U per kilogram of body weight) or saline placebo was administered intravenously within 26 hours after birth, as well as at 2, 3, 4, and 7 days of age. The primary outcome was death or neurodevelopmental impairment at 22 to 36 months of age. Neurodevelopmental impairment was defined as cerebral palsy, a Gross Motor Function Classification System level of at least 1 (on a scale of 0 [normal] to 5 [most impaired]), or a cognitive score of less than 90 (which corresponds to 0.67 SD below the mean, with higher scores indicating better performance) on the Bayley Scales of Infant and Toddler Development, third edition. Results: Of 500 infants in the modified intention-to-treat analysis, 257 received erythropoietin and 243 received placebo. The incidence of death or neurodevelopmental impairment was 52.5% in the erythropoietin group and 49.5% in the placebo group (relative risk, 1.03; 95% confidence interval [CI], 0.86 to 1.24; P = 0.74). The mean number of serious adverse events per child was higher in the erythropoietin group than in the placebo group (0.86 vs. 0.67; relative risk, 1.26; 95% CI, 1.01 to 1.57). Conclusions: The administration of erythropoietin to newborns undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy did not result in a lower risk of death or neurodevelopmental impairment than placebo and was associated with a higher rate of serious adverse events.