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

the PENUT Trial Consortium; David J. Askenazi; Patrick J. Heagerty; Robert H. Schmicker; Patrick Brophy; Sandra E. Juul; Stuart L. Goldstein; Sangeeta Hingorani; Bryan A. Comstock; Rajan Wadhawan; Dennis E. Mayock; Sherry E. Courtney; Tonya Robinson; Kaashif A. Ahmad; Ellen Bendel-Stenzel; Mariana Baserga; Edmund F. LaGamma; L. Corbin Downey; Raghavendra Rao; Nancy Fahim; Andrea Lampland; Ivan D. Frantz; Janine Y. Khan; Michael Weiss; Maureen M. Gilmore; Robin Ohls; Nishant Srinivasan; Jorge E. Perez; Victor McKay; Phuong T. Vu; Billy Thomas; Nahed Elhassan; Sarah Mulkey; Sara Ramel; Cheryl Gale; Tom George; Michael Georgieff; Tate Gisslen; Dana Johnson; Erin Stepka; Melissa Engel; Heidi Kamrath; Johannah Scheurer; Katherine Satrom; Erin Plummer; Tyler Richter; Elizabeth I. Pierpont; Erin A Osterholm; Tom George; Kelly E. King; Mark Bergeron; Cristina Miller; Katie M Pfister; Kari D Roberts

doi:10.1016/j.jpeds.2021.01.031

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

the PENUT Trial Consortium, David J. Askenazi, Patrick J. Heagerty, Robert H. Schmicker, Patrick Brophy, Sandra E. Juul, Stuart L. Goldstein, Sangeeta Hingorani, Bryan A. Comstock, Rajan Wadhawan, Dennis E. Mayock, Sherry E. Courtney, Tonya Robinson, Kaashif A. Ahmad, Ellen Bendel-Stenzel, Mariana Baserga, Edmund F. LaGamma, L. Corbin Downey, Raghavendra Rao, Nancy FahimAndrea Lampland, Ivan D. Frantz, Janine Y. Khan, Michael Weiss, Maureen M. Gilmore, Robin Ohls, Nishant Srinivasan, Jorge E. Perez, Victor McKay, Phuong T. Vu, Billy Thomas, Nahed Elhassan, Sarah Mulkey, Sara Ramel, Cheryl Gale, Tom George, Michael Georgieff, Tate Gisslen, Dana Johnson, Erin Stepka, Melissa Engel, Heidi Kamrath, Johannah Scheurer, Katherine Satrom, Erin Plummer, Tyler Richter, Elizabeth I. Pierpont, Erin A Osterholm, Tom George, Kelly E. King, Mark Bergeron, Cristina Miller, Katie M Pfister, Kari D Roberts

Research output: Contribution to journal › Article › peer-review

21 Scopus citations

Abstract

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 m 2, 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.

Original language	English (US)
Journal	Journal of Pediatrics
Volume	232
DOIs	https://doi.org/10.1016/j.jpeds.2021.01.031
State	Published - May 2021

Bibliographical note

Funding Information:
Recombinant Erythropoietin for Protection of Infant Renal Disease (REPaIReD) Study is a National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases –funded (R01 DK103608) ancillary study designed to look at kidney outcomes in patients enrolled in the Preterm Erythropoietin Neuroprotection Trial (PENUT), which is an NIH National Institute of Neurological Disorders and Stroke –funded (U01 NS077953, U01 NS077955) trial. The clinicaltrials.gov identifier is NCT01378273 . Funding sources for this study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. D.A. is consultant for Baxter, CHF Solutions Inc, Medtronic, Bioporto, and AKI Foundation; and receives external grant funding for research and education for projects not related to this report from Baxter , CHF Solutions Inc , Medtronic and NIH . S.G. reports personal fees from and a position as a consultant to CHF Solutions Inc, Renibus, ExThera, Reata, and Medtronic Inc; receives grant funding from and serves as a consultant and on a Speaker's Bureau for Baxter Healthcare, Inc ; receives grant funding and serves as a consultant for BioPorto, Inc ; and serves on a Speaker's Bureau for Fresenius Medical Corporation. R.S. receives grant funding for studies not related to this project from National Heart, Lung, and Blood Institute and Patient-Centered Outcomes Research Institute . The other authors declare no conflicts of interest.

Funding Information:
Recombinant Erythropoietin for Protection of Infant Renal Disease (REPaIReD) Study is a National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases?funded (R01 DK103608) ancillary study designed to look at kidney outcomes in patients enrolled in the Preterm Erythropoietin Neuroprotection Trial (PENUT), which is an NIH National Institute of Neurological Disorders and Stroke?funded (U01 NS077953, U01 NS077955) trial. The clinicaltrials.gov identifier is NCT01378273. Funding sources for this study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. D.A. is consultant for Baxter, CHF Solutions Inc, Medtronic, Bioporto, and AKI Foundation; and receives external grant funding for research and education for projects not related to this report from Baxter, CHF Solutions Inc, Medtronic and NIH. S.G. reports personal fees from and a position as a consultant to CHF Solutions Inc, Renibus, ExThera, Reata, and Medtronic Inc; receives grant funding from and serves as a consultant and on a Speaker's Bureau for Baxter Healthcare, Inc; receives grant funding and serves as a consultant for BioPorto, Inc; and serves on a Speaker's Bureau for Fresenius Medical Corporation. R.S. receives grant funding for studies not related to this project from National Heart, Lung, and Blood Institute and Patient-Centered Outcomes Research Institute. The other authors declare no conflicts of interest. Funding and conflicts of interest statement available at www.jpeds.com.

Publisher Copyright:
© 2021 Elsevier Inc.

Keywords

acute kidney injury
acute renal failure
chronic kidney disease
hypertension
proteinuria

PubMed: MeSH publication types

Journal Article
Research Support, N.I.H., Extramural
Multicenter Study
Randomized Controlled Trial

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jpeds.2021.01.031

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the PENUT Trial Consortium, Askenazi, D. J., Heagerty, P. J., Schmicker, R. H., Brophy, P., Juul, S. E., Goldstein, S. L., Hingorani, S., Comstock, B. A., Wadhawan, R., Mayock, D. E., Courtney, S. E., Robinson, T., Ahmad, K. A., Bendel-Stenzel, E., Baserga, M., LaGamma, E. F., Downey, L. C., Rao, R., ... Roberts, K. D. (2021). 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. Journal of Pediatrics, 232. https://doi.org/10.1016/j.jpeds.2021.01.031

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. / the PENUT Trial Consortium; Askenazi, David J.; Heagerty, Patrick J. et al.
In: Journal of Pediatrics, Vol. 232, 05.2021.

Research output: Contribution to journal › Article › peer-review

the PENUT Trial Consortium, Askenazi, DJ, Heagerty, PJ, Schmicker, RH, Brophy, P, Juul, SE, Goldstein, SL, Hingorani, S, Comstock, BA, Wadhawan, R, Mayock, DE, Courtney, SE, Robinson, T, Ahmad, KA, Bendel-Stenzel, E, Baserga, M, LaGamma, EF, Downey, LC, Rao, R , Fahim, N, Lampland, A, Frantz, ID, Khan, JY, Weiss, M, Gilmore, MM, Ohls, R, Srinivasan, N, Perez, JE, McKay, V, Vu, PT, Thomas, B, Elhassan, N, Mulkey, S, Ramel, S , Gale, C , George, T , Georgieff, M , Gisslen, T , Johnson, D , Stepka, E , Engel, M, Kamrath, H, Scheurer, J , Satrom, K , Plummer, E, Richter, T, Pierpont, EI , Osterholm, EA , George, T , King, KE, Bergeron, M, Miller, C, Pfister, KM & Roberts, KD 2021, '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', Journal of Pediatrics, vol. 232. https://doi.org/10.1016/j.jpeds.2021.01.031

the PENUT Trial Consortium, Askenazi DJ, Heagerty PJ, Schmicker RH, Brophy P, Juul SE et al. 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. Journal of Pediatrics. 2021 May;232. doi: 10.1016/j.jpeds.2021.01.031

@article{da5b77e70dba4f75860dd414ba5991b3,

title = "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",

abstract = "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 m 2, 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.",

keywords = "acute kidney injury, acute renal failure, chronic kidney disease, hypertension, proteinuria",

author = "{the PENUT Trial Consortium} and Askenazi, {David J.} and Heagerty, {Patrick J.} and Schmicker, {Robert H.} and Patrick Brophy and Juul, {Sandra E.} and Goldstein, {Stuart L.} and Sangeeta Hingorani and Comstock, {Bryan A.} and Rajan Wadhawan and Mayock, {Dennis E.} and Courtney, {Sherry E.} and Tonya Robinson and Ahmad, {Kaashif A.} and Ellen Bendel-Stenzel and Mariana Baserga and LaGamma, {Edmund F.} and Downey, {L. Corbin} and Raghavendra Rao and Nancy Fahim and Andrea Lampland and Frantz, {Ivan D.} and Khan, {Janine Y.} and Michael Weiss and Gilmore, {Maureen M.} and Robin Ohls and Nishant Srinivasan and Perez, {Jorge E.} and Victor McKay and Vu, {Phuong T.} and Billy Thomas and Nahed Elhassan and Sarah Mulkey and Sara Ramel and Cheryl Gale and Tom George and Michael Georgieff and Tate Gisslen and Dana Johnson and Erin Stepka and Melissa Engel and Heidi Kamrath and Johannah Scheurer and Katherine Satrom and Erin Plummer and Tyler Richter and Pierpont, {Elizabeth I.} and Osterholm, {Erin A} and Tom George and King, {Kelly E.} and Mark Bergeron and Cristina Miller and Pfister, {Katie M} and Roberts, {Kari D}",

note = "Funding Information: Recombinant Erythropoietin for Protection of Infant Renal Disease (REPaIReD) Study is a National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases –funded (R01 DK103608) ancillary study designed to look at kidney outcomes in patients enrolled in the Preterm Erythropoietin Neuroprotection Trial (PENUT), which is an NIH National Institute of Neurological Disorders and Stroke –funded (U01 NS077953, U01 NS077955) trial. The clinicaltrials.gov identifier is NCT01378273 . Funding sources for this study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. D.A. is consultant for Baxter, CHF Solutions Inc, Medtronic, Bioporto, and AKI Foundation; and receives external grant funding for research and education for projects not related to this report from Baxter , CHF Solutions Inc , Medtronic and NIH . S.G. reports personal fees from and a position as a consultant to CHF Solutions Inc, Renibus, ExThera, Reata, and Medtronic Inc; receives grant funding from and serves as a consultant and on a Speaker's Bureau for Baxter Healthcare, Inc ; receives grant funding and serves as a consultant for BioPorto, Inc ; and serves on a Speaker's Bureau for Fresenius Medical Corporation. R.S. receives grant funding for studies not related to this project from National Heart, Lung, and Blood Institute and Patient-Centered Outcomes Research Institute . The other authors declare no conflicts of interest. Funding Information: Recombinant Erythropoietin for Protection of Infant Renal Disease (REPaIReD) Study is a National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases?funded (R01 DK103608) ancillary study designed to look at kidney outcomes in patients enrolled in the Preterm Erythropoietin Neuroprotection Trial (PENUT), which is an NIH National Institute of Neurological Disorders and Stroke?funded (U01 NS077953, U01 NS077955) trial. The clinicaltrials.gov identifier is NCT01378273. Funding sources for this study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. D.A. is consultant for Baxter, CHF Solutions Inc, Medtronic, Bioporto, and AKI Foundation; and receives external grant funding for research and education for projects not related to this report from Baxter, CHF Solutions Inc, Medtronic and NIH. S.G. reports personal fees from and a position as a consultant to CHF Solutions Inc, Renibus, ExThera, Reata, and Medtronic Inc; receives grant funding from and serves as a consultant and on a Speaker's Bureau for Baxter Healthcare, Inc; receives grant funding and serves as a consultant for BioPorto, Inc; and serves on a Speaker's Bureau for Fresenius Medical Corporation. R.S. receives grant funding for studies not related to this project from National Heart, Lung, and Blood Institute and Patient-Centered Outcomes Research Institute. The other authors declare no conflicts of interest. Funding and conflicts of interest statement available at www.jpeds.com. Publisher Copyright: {\textcopyright} 2021 Elsevier Inc.",

year = "2021",

month = may,

doi = "10.1016/j.jpeds.2021.01.031",

language = "English (US)",

volume = "232",

journal = "Journal of Pediatrics",

issn = "0022-3476",

publisher = "Elsevier Inc.",

}

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 - Ramel, Sara

AU - Gale, Cheryl

AU - George, Tom

AU - Georgieff, Michael

AU - Gisslen, Tate

AU - Johnson, Dana

AU - Stepka, Erin

AU - Engel, Melissa

AU - Kamrath, Heidi

AU - Scheurer, Johannah

AU - Satrom, Katherine

AU - Plummer, Erin

AU - Richter, Tyler

AU - Pierpont, Elizabeth I.

AU - Osterholm, Erin A

AU - George, Tom

AU - King, Kelly E.

AU - Bergeron, Mark

AU - Miller, Cristina

AU - Pfister, Katie M

AU - Roberts, Kari D

N1 - Funding Information: Recombinant Erythropoietin for Protection of Infant Renal Disease (REPaIReD) Study is a National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases –funded (R01 DK103608) ancillary study designed to look at kidney outcomes in patients enrolled in the Preterm Erythropoietin Neuroprotection Trial (PENUT), which is an NIH National Institute of Neurological Disorders and Stroke –funded (U01 NS077953, U01 NS077955) trial. The clinicaltrials.gov identifier is NCT01378273 . Funding sources for this study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. D.A. is consultant for Baxter, CHF Solutions Inc, Medtronic, Bioporto, and AKI Foundation; and receives external grant funding for research and education for projects not related to this report from Baxter , CHF Solutions Inc , Medtronic and NIH . S.G. reports personal fees from and a position as a consultant to CHF Solutions Inc, Renibus, ExThera, Reata, and Medtronic Inc; receives grant funding from and serves as a consultant and on a Speaker's Bureau for Baxter Healthcare, Inc ; receives grant funding and serves as a consultant for BioPorto, Inc ; and serves on a Speaker's Bureau for Fresenius Medical Corporation. R.S. receives grant funding for studies not related to this project from National Heart, Lung, and Blood Institute and Patient-Centered Outcomes Research Institute . The other authors declare no conflicts of interest. Funding Information: Recombinant Erythropoietin for Protection of Infant Renal Disease (REPaIReD) Study is a National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases?funded (R01 DK103608) ancillary study designed to look at kidney outcomes in patients enrolled in the Preterm Erythropoietin Neuroprotection Trial (PENUT), which is an NIH National Institute of Neurological Disorders and Stroke?funded (U01 NS077953, U01 NS077955) trial. The clinicaltrials.gov identifier is NCT01378273. Funding sources for this study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. D.A. is consultant for Baxter, CHF Solutions Inc, Medtronic, Bioporto, and AKI Foundation; and receives external grant funding for research and education for projects not related to this report from Baxter, CHF Solutions Inc, Medtronic and NIH. S.G. reports personal fees from and a position as a consultant to CHF Solutions Inc, Renibus, ExThera, Reata, and Medtronic Inc; receives grant funding from and serves as a consultant and on a Speaker's Bureau for Baxter Healthcare, Inc; receives grant funding and serves as a consultant for BioPorto, Inc; and serves on a Speaker's Bureau for Fresenius Medical Corporation. R.S. receives grant funding for studies not related to this project from National Heart, Lung, and Blood Institute and Patient-Centered Outcomes Research Institute. The other authors declare no conflicts of interest. Funding and conflicts of interest statement available at www.jpeds.com. Publisher Copyright: © 2021 Elsevier Inc.

PY - 2021/5

Y1 - 2021/5

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 m 2, 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 m 2, 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

UR - http://www.scopus.com/inward/record.url?scp=85101368384&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85101368384&partnerID=8YFLogxK

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

VL - 232

JO - Journal of Pediatrics

JF - Journal of Pediatrics

ER -

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

Abstract

Bibliographical note

Keywords

PubMed: MeSH publication types

UN SDGs

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