TY - JOUR
T1 - The Impact of Erythropoietin on Short- and Long-Term Kidney-Related Outcomes in Neonates of Extremely Low Gestational Age. Results of a Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial
AU - the PENUT Trial Consortium
AU - Askenazi, David J.
AU - Heagerty, Patrick J.
AU - Schmicker, Robert H.
AU - Brophy, Patrick
AU - Juul, Sandra E.
AU - Goldstein, Stuart L.
AU - Hingorani, Sangeeta
AU - Comstock, Bryan A.
AU - Wadhawan, Rajan
AU - Mayock, Dennis E.
AU - Courtney, Sherry E.
AU - Robinson, Tonya
AU - Ahmad, Kaashif A.
AU - Bendel-Stenzel, Ellen
AU - Baserga, Mariana
AU - LaGamma, Edmund F.
AU - Downey, L. Corbin
AU - Rao, Raghavendra
AU - Fahim, Nancy
AU - Lampland, Andrea
AU - Frantz, Ivan D.
AU - Khan, Janine Y.
AU - Weiss, Michael
AU - Gilmore, Maureen M.
AU - Ohls, Robin
AU - Srinivasan, Nishant
AU - Perez, Jorge E.
AU - McKay, Victor
AU - Vu, Phuong T.
AU - Thomas, Billy
AU - Elhassan, Nahed
AU - Mulkey, Sarah
AU - Dydynski, Philip
AU - Vijayamadhavan, Vivek K.
AU - Mulrooney, Neil
AU - Yoder, Bradley
AU - Kase, Jordan S.
AU - Check, Jennifer
AU - Gogcu, Semsa
AU - Osterholm, Erin
AU - Ramel, Sara
AU - Bendel, Catherine
AU - Gale, Cheryl
AU - George, Thomas
AU - Georgieff, Michael
AU - Gisslen, Tate
AU - Northington, Frances
AU - Valdez, Raul Chavez
AU - Ditto, Jessica
AU - Leppert, Mary
N1 - Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021
Y1 - 2021
N2 - Objective: To evaluate whether extremely low gestational age neonates (ELGANs) randomized to erythropoietin have better or worse kidney-related outcomes during hospitalization and at 22-26 months of corrected gestational age (cGA) compared with those randomized to placebo. Study design: We performed an ancillary study to a multicenter double-blind, placebo-controlled randomized clinical trial of erythropoietin in ELGANs. Results: The prevalence of severe (stage 2 or 3) acute kidney injury (AKI) was 18.2%. We did not find a statistically significant difference between those randomized to erythropoietin vs placebo for in-hospital primary (severe AKI) or secondary outcomes (any AKI and serum creatinine/cystatin C values at days 0, 7, 9, and 14). At 22-26 months of cGA, 16% of the cohort had an estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2, 35.8% had urine albumin/creatinine ratio >30 mg/g, 23% had a systolic blood pressure (SBP) >95th percentile for age, and 40% had a diastolic blood pressure (DBP) >95th percentile for age. SBP >90th percentile occurred less often among recipients of erythropoietin (P < .04). This association remained even after controlling for gestational age, site, and sibship (aOR 0.6; 95% CI 0.39-0.92). We did not find statistically significant differences between treatment groups in eGFR, albumin/creatinine ratio, rates of SBP >95th percentile, or DBP >90th or >95th percentiles at the 2 year follow-up visit. Conclusions: ELGANs have high rates of in-hospital AKI and kidney-related problems at 22-26 months of cGA. Recombinant erythropoietin may protect ELGANs against long-term elevated SBP but does not appear to protect from AKI, low eGFR, albuminuria, or elevated DBP at 22-26 months of cGA.
AB - Objective: To evaluate whether extremely low gestational age neonates (ELGANs) randomized to erythropoietin have better or worse kidney-related outcomes during hospitalization and at 22-26 months of corrected gestational age (cGA) compared with those randomized to placebo. Study design: We performed an ancillary study to a multicenter double-blind, placebo-controlled randomized clinical trial of erythropoietin in ELGANs. Results: The prevalence of severe (stage 2 or 3) acute kidney injury (AKI) was 18.2%. We did not find a statistically significant difference between those randomized to erythropoietin vs placebo for in-hospital primary (severe AKI) or secondary outcomes (any AKI and serum creatinine/cystatin C values at days 0, 7, 9, and 14). At 22-26 months of cGA, 16% of the cohort had an estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2, 35.8% had urine albumin/creatinine ratio >30 mg/g, 23% had a systolic blood pressure (SBP) >95th percentile for age, and 40% had a diastolic blood pressure (DBP) >95th percentile for age. SBP >90th percentile occurred less often among recipients of erythropoietin (P < .04). This association remained even after controlling for gestational age, site, and sibship (aOR 0.6; 95% CI 0.39-0.92). We did not find statistically significant differences between treatment groups in eGFR, albumin/creatinine ratio, rates of SBP >95th percentile, or DBP >90th or >95th percentiles at the 2 year follow-up visit. Conclusions: ELGANs have high rates of in-hospital AKI and kidney-related problems at 22-26 months of cGA. Recombinant erythropoietin may protect ELGANs against long-term elevated SBP but does not appear to protect from AKI, low eGFR, albuminuria, or elevated DBP at 22-26 months of cGA.
KW - acute kidney injury
KW - acute renal failure
KW - chronic kidney disease
KW - hypertension
KW - proteinuria
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U2 - 10.1016/j.jpeds.2021.01.031
DO - 10.1016/j.jpeds.2021.01.031
M3 - Article
C2 - 33484699
AN - SCOPUS:85101368384
SN - 0022-3476
JO - Journal of Pediatrics
JF - Journal of Pediatrics
ER -