Association between Term Equivalent Brain Magnetic Resonance Imaging and 2-Year Outcomes in Extremely Preterm Infants: A Report from the Preterm Erythropoietin Neuroprotection Trial Cohort

Mayock, Dennis E.; Gogcu, Semsa; Puia‐Dumitrescu, Mihai; Shaw, Dennis; Wright, Jason N.; Comstock, Bryan A.; Heagerty, Patrick J.; Juul, Sandra E.; Wadhawan, Rajan; Courtney, Sherry E.; Robinson, Tonya; Ahmad, Kaashif A.; Bendel-Stenzel, Ellen; Baserga, Mariana; LaGamma, Edmund F.; Downey, L. Corbin; Rao, Raghavendra; Fahim, Nancy; Lampland, Andrea; Frantz, Ivan D.; Khan, Janine Y.; Weiss, Michael; Gilmore, Maureen; Ohls, Robin K.; Lowe, Jean; Srinivasan, Nishant; Pérez, Jorge Enrique; McKay, Victor; Thomas, Billy; ElHassan, Nahed O.; Mulkey, Sarah B.; Vijayamadhavan, Vivek K.; Mulrooney, Neil; Yoder, Bradley A.; Kase, Jordan S.; Check, Jennifer; Osterholm, Erin; George, T. Neville; Georgieff, Michael; Martin, Camilia R.; O’Reilly, Deirdre; deRegnier, Raye‐Ann; Porta, Nicolas F M; Bazacliu, Catalina; Northington, Frances J.; Valdez, Raul Chavez; Saurabhkumar, Patel; Diaz-Barbosa, Magaly; Richards, Todd L.; Feltner, John; Esposito, Isabella; Hauge, Stephanie; Nikirk, Samantha; Silvia, Amy; Clopp, Bailey; Ott, Debbie; Mora, Ariana Franco; Hedrick, Pamela; Flynn, Vicki; Wyatt, Andrea; Loy, Emilie; Sikes, Natalie; Mason, Melanie; McConnell, Jana; Brown, Tiffany; Harrison, H. Robert; Pearson, Denise J.; Drake, Tammy; Wright, Jocelyn H.; Walden, Debra; Guy, Annette; Nason, Jennifer; Talbot, Morgan; Lee, Kristen; Penny, Sarah; Boles, Terri; Drummond, Melanie; Kohlleppel, Katy; Kathen, Charmaine; Kaletka, Brian; Gonzales, Shania; Worwa, Cathy; Fisher, Molly; Richter, Tyler; Ginder, Alexander; Reich, Brixen; Rau, Carrie A.; Loertscher, Manndi C.; Cole, Laura K.; McGrath, Kandace; Lewis, Kimberlee Weaver; Burnett, Jill; Schaefer, Susan T.; Bird, Karie; Giblin, Clare; Daly, Rita; Lanier, Kristi; Warden, Kelly; Wassenaar, Jenna; Ericksen, Jensina; Davern, Bridget; Osborne, Mary Pat; Talele, Neha; Obregon, Evelyn; Ziyeh, Tiglath; Clarke, Molly; Wegner, Rachel E.; Patel, Palak; Schau, Molly; Russow, Annamarie; Curry, Kelly; Barnhart, Lisa A.; Parkinson, Charlamaine; Beauman, Sandra Sundquist; Hanson, Mary; Kuan, Elizabeth; Lacy, Conra Backstrom; Galvis, Edshelee M.; Bombino, Susana; Martinez, Denise; Bell, Suzi; Long, Corrie; Nefcy, Christopher; Konodi, Mark A.; Vu, Phuong T.; Hartman, Adam L.; O’Shea, T. Michael; Ballard, Roberta A.; O'Shea, M.; Kuban, Karl; Widness, John A.

doi:10.1016/j.jpeds.2021.08.040

Cited by 6 publications

(1 citation statement)

References 33 publications

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“…The earlier trial excluded infants with grade 2 or higher IVH detected within the first 36 hours of life. In line with our findings, brain MRI data from the large, US Preterm Erythropoietin Neuroprotection Trial (PENUT) show no difference between the erythropoietin and placebo groups.…”

Section: Discussionsupporting

confidence: 89%

Safety and Short-term Outcomes of High-Dose Erythropoietin in Preterm Infants With Intraventricular Hemorrhage

et al. 2022

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ImportanceIntraventricular hemorrhage (IVH) is a major cause of neonatal morbidity and mortality in preterm infants without a specific medical treatment to date.ObjectiveTo assess the safety and short-term outcomes of high-dose erythropoietin in preterm infants with IVH.Design, Setting, and ParticipantsBetween April 1, 2014, and August 3, 2018, a randomized double-blind clinical trial enrolled 121 preterm infants (gestational age &lt;32 weeks or birth weight &lt;1500 g) aged 8 or less days with moderate to severe IVH identified by cerebral ultrasonography from 8 Swiss and Austrian tertiary neonatal units. Statistical analyses were performed between October 1, 2019, and September 12, 2022.InterventionsInfants received intravenous high-dose erythropoietin (2000 units/kg body weight) or placebo at 4 time points between weeks 1 and 4 of life.Main Outcomes and MeasuresSecondary outcomes included (1) mortality and morbidity rates and (2) brain magnetic resonance imaging findings at term-equivalent age (TEA). The primary outcome was the composite intelligence quotient at 5 years of age (not available before 2023).ResultsSixty infants (48% male [n = 29]) were randomly assigned to receive erythropoietin, and 61 infants (61% male [n = 37]) were randomly assigned to receive placebo. The median birth weight was 832 g (IQR, 687-990 g) in the erythropoietin group and 870 g (IQR, 680-1110 g) in the placebo group. Median gestation was 26.1 weeks (IQR, 24.8-27.3 weeks) in the erythropoietin group and 27.0 weeks (24.9–28.1 weeks) in the placebo group. The 2 groups had similar baseline characteristics and morbidities. Up to TEA, 10 newborns died (16.7%) in the erythropoietin group, and 5 newborns (8.2%) died in the placebo group (adjusted odds ratio, 2.24 [95% CI, 0.74-7.66]; P = .15). Infants receiving erythropoietin had higher mean hematocrit levels. Conventional magnetic resonance imaging at TEA for 100 infants showed no significant differences in global or regional brain injury scores.Conclusions and RelevanceThis preliminary report of a randomized clinical trial found no evidence that high-dose erythropoietin in preterm infants with IVH affects brain injury scores on conventional magnetic resonance imaging at TEA. Higher mortality in the erythropoietin group was not significant but should be reassessed based on future results from similar trials.Trial RegistrationClinicalTrials.gov Identifier: NCT02076373

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Section: Discussionsupporting

confidence: 89%