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
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. We performed an ancillary study to a...
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| Veröffentlicht in: | The Journal of pediatrics 2021-05, Vol.232, p.65-72.e7 |
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| creator | Askenazi, David J. Schmicker, Robert H. Brophy, Patrick Comstock, Bryan A. Wadhawan, Rajan Baserga, Mariana LaGamma, Edmund F. Downey, L. Corbin Rao, Raghavendra Khan, Janine Y. Weiss, Michael Ohls, Robin Perez, Jorge E. Vu, Phuong T. Thomas, Billy Elhassan, Nahed Dydynski, Philip Mulrooney, Neil Yoder, Bradley Kase, Jordan S. Ramel, Sara Georgieff, Michael Gisslen, Tate Hall, Anne Johnson, Dana Kamrath, Heidi Hanson, Angela Satrom, Katherine Simones, Ann Plummer, Erin Zorn, Elizabeth Porta, Nicolas Rajderkar, Dhanashree Northington, Frances Beauman, Sandra Diaz-Barbosa, Magaly Serize, Arturo Mora, Ariana Franco Silvia, Amy Clopp, Bailey Feltner, John B. Esposito, Isabella Purnell, Andrea Loy, Emilie Sikes, Natalie Drake, Tammy Wright, Jocelyn Walden, Debra Nason, Jennifer Penny, Sarah Boles, Terri Kohlleppel, Katy Kaletka, Brian Worwa, Cathy Reich, Brixen Rau, Carrie Lewis, Kimberlee Weaver Giblin, Clare Daly, Rita Wassenaar, Jenna Obregon, Evelyn Wegner, Rachel E. Russow, Annamarie Barnhart, Lisa Galvis, Edshelee M. Bell, Suzi Westerveld, Michael Natarajan, Niranjana Gaudette, Shari Schumacher, Elizabeth Schuschke, Leslie Fierro, Mario Perdue, Nina Cunningham, Sean Stout, Kelly Cox, Lauren Hensley, Sarah Roberts, Dia Boys, Christopher Hultgren, Solveig Pierpont, Elizabeth I. Bataglia, Katherine Neis, Cathy Bergeron, Mark Accomando, Cara Gavin, Jennifer Anne Maczek, Elizabeth Smith, Vincent C. Weissbourd, Marie Matoba, Nana Heaton, Shelly C. Leppert, Mary Patel, Saurabh Chavis, Lacy Shannon, Jane Nefcy, Christopher Lowe, Jean R. Ballard, Roberta Janis, Scott O'Shea, Michael |
| description | 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.
We performed an ancillary study to a multicenter double-blind, placebo-controlled randomized clinical trial of erythropoietin in ELGANs.
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) 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 95th percentile, or DBP >90th or >95th percentiles at the 2 year follow-up visit.
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. |
| doi_str_mv | 10.1016/j.jpeds.2021.01.031 |
| format | Article |
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Results of a Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial</title><source>MEDLINE</source><source>Access via ScienceDirect (Elsevier)</source><creator>Askenazi, David J. ; Schmicker, Robert H. ; Brophy, Patrick ; Comstock, Bryan A. ; Wadhawan, Rajan ; Baserga, Mariana ; LaGamma, Edmund F. ; Downey, L. Corbin ; Rao, Raghavendra ; Khan, Janine Y. ; Weiss, Michael ; Ohls, Robin ; Perez, Jorge E. ; Vu, Phuong T. ; Thomas, Billy ; Elhassan, Nahed ; Dydynski, Philip ; Mulrooney, Neil ; Yoder, Bradley ; Kase, Jordan S. ; Ramel, Sara ; Georgieff, Michael ; Gisslen, Tate ; Hall, Anne ; Johnson, Dana ; Kamrath, Heidi ; Hanson, Angela ; Satrom, Katherine ; Simones, Ann ; Plummer, Erin ; Zorn, Elizabeth ; Porta, Nicolas ; Rajderkar, Dhanashree ; Northington, Frances ; Beauman, Sandra ; Diaz-Barbosa, Magaly ; Serize, Arturo ; Mora, Ariana Franco ; Silvia, Amy ; Clopp, Bailey ; Feltner, John B. ; Esposito, Isabella ; Purnell, Andrea ; Loy, Emilie ; Sikes, Natalie ; Drake, Tammy ; Wright, Jocelyn ; Walden, Debra ; Nason, Jennifer ; Penny, Sarah ; Boles, Terri ; Kohlleppel, Katy ; Kaletka, Brian ; Worwa, Cathy ; Reich, Brixen ; Rau, Carrie ; Lewis, Kimberlee Weaver ; Giblin, Clare ; Daly, Rita ; Wassenaar, Jenna ; Obregon, Evelyn ; Wegner, Rachel E. ; Russow, Annamarie ; Barnhart, Lisa ; Galvis, Edshelee M. ; Bell, Suzi ; Westerveld, Michael ; Natarajan, Niranjana ; Gaudette, Shari ; Schumacher, Elizabeth ; Schuschke, Leslie ; Fierro, Mario ; Perdue, Nina ; Cunningham, Sean ; Stout, Kelly ; Cox, Lauren ; Hensley, Sarah ; Roberts, Dia ; Boys, Christopher ; Hultgren, Solveig ; Pierpont, Elizabeth I. ; Bataglia, Katherine ; Neis, Cathy ; Bergeron, Mark ; Accomando, Cara ; Gavin, Jennifer Anne ; Maczek, Elizabeth ; Smith, Vincent C. ; Weissbourd, Marie ; Matoba, Nana ; Heaton, Shelly C. ; Leppert, Mary ; Patel, Saurabh ; Chavis, Lacy ; Shannon, Jane ; Nefcy, Christopher ; Lowe, Jean R. ; Ballard, Roberta ; Janis, Scott ; O'Shea, Michael</creator><creatorcontrib>Askenazi, David J. ; Schmicker, Robert H. ; Brophy, Patrick ; Comstock, Bryan A. ; Wadhawan, Rajan ; Baserga, Mariana ; LaGamma, Edmund F. ; Downey, L. Corbin ; Rao, Raghavendra ; Khan, Janine Y. ; Weiss, Michael ; Ohls, Robin ; Perez, Jorge E. ; Vu, Phuong T. ; Thomas, Billy ; Elhassan, Nahed ; Dydynski, Philip ; Mulrooney, Neil ; Yoder, Bradley ; Kase, Jordan S. ; Ramel, Sara ; Georgieff, Michael ; Gisslen, Tate ; Hall, Anne ; Johnson, Dana ; Kamrath, Heidi ; Hanson, Angela ; Satrom, Katherine ; Simones, Ann ; Plummer, Erin ; Zorn, Elizabeth ; Porta, Nicolas ; Rajderkar, Dhanashree ; Northington, Frances ; Beauman, Sandra ; Diaz-Barbosa, Magaly ; Serize, Arturo ; Mora, Ariana Franco ; Silvia, Amy ; Clopp, Bailey ; Feltner, John B. ; Esposito, Isabella ; Purnell, Andrea ; Loy, Emilie ; Sikes, Natalie ; Drake, Tammy ; Wright, Jocelyn ; Walden, Debra ; Nason, Jennifer ; Penny, Sarah ; Boles, Terri ; Kohlleppel, Katy ; Kaletka, Brian ; Worwa, Cathy ; Reich, Brixen ; Rau, Carrie ; Lewis, Kimberlee Weaver ; Giblin, Clare ; Daly, Rita ; Wassenaar, Jenna ; Obregon, Evelyn ; Wegner, Rachel E. ; Russow, Annamarie ; Barnhart, Lisa ; Galvis, Edshelee M. ; Bell, Suzi ; Westerveld, Michael ; Natarajan, Niranjana ; Gaudette, Shari ; Schumacher, Elizabeth ; Schuschke, Leslie ; Fierro, Mario ; Perdue, Nina ; Cunningham, Sean ; Stout, Kelly ; Cox, Lauren ; Hensley, Sarah ; Roberts, Dia ; Boys, Christopher ; Hultgren, Solveig ; Pierpont, Elizabeth I. ; Bataglia, Katherine ; Neis, Cathy ; Bergeron, Mark ; Accomando, Cara ; Gavin, Jennifer Anne ; Maczek, Elizabeth ; Smith, Vincent C. ; Weissbourd, Marie ; Matoba, Nana ; Heaton, Shelly C. ; Leppert, Mary ; Patel, Saurabh ; Chavis, Lacy ; Shannon, Jane ; Nefcy, Christopher ; Lowe, Jean R. ; Ballard, Roberta ; Janis, Scott ; O'Shea, Michael ; the PENUT Trial Consortium ; PENUT Trial Consortium</creatorcontrib><description>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.
We performed an ancillary study to a multicenter double-blind, placebo-controlled randomized clinical trial of erythropoietin in ELGANs.
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.
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.</description><identifier>ISSN: 0022-3476</identifier><identifier>EISSN: 1097-6833</identifier><identifier>DOI: 10.1016/j.jpeds.2021.01.031</identifier><identifier>PMID: 33484699</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>acute kidney injury ; Acute Kidney Injury - classification ; Acute Kidney Injury - epidemiology ; acute renal failure ; Albuminuria - epidemiology ; chronic kidney disease ; Double-Blind Method ; Erythropoietin - therapeutic use ; Female ; Gestational Age ; Glomerular Filtration Rate ; Humans ; hypertension ; Hypertension - epidemiology ; Infant, Extremely Premature ; Infant, Newborn ; Infant, Premature, Diseases - epidemiology ; Male ; proteinuria ; Recombinant Proteins - therapeutic use ; Renal Insufficiency, Chronic - epidemiology</subject><ispartof>The Journal of pediatrics, 2021-05, Vol.232, p.65-72.e7</ispartof><rights>2021 Elsevier Inc.</rights><rights>Copyright © 2021 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c404t-a51f6f9b1fb6dce58c27e53223c393ba8691ae28f9a026a274e1896aadaa9ca03</citedby><cites>FETCH-LOGICAL-c404t-a51f6f9b1fb6dce58c27e53223c393ba8691ae28f9a026a274e1896aadaa9ca03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jpeds.2021.01.031$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>315,781,785,3551,27926,27927,45997</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33484699$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Askenazi, David J.</creatorcontrib><creatorcontrib>Schmicker, Robert H.</creatorcontrib><creatorcontrib>Brophy, Patrick</creatorcontrib><creatorcontrib>Comstock, Bryan A.</creatorcontrib><creatorcontrib>Wadhawan, Rajan</creatorcontrib><creatorcontrib>Baserga, Mariana</creatorcontrib><creatorcontrib>LaGamma, Edmund F.</creatorcontrib><creatorcontrib>Downey, L. 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Results of a Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial</title><title>The Journal of pediatrics</title><addtitle>J Pediatr</addtitle><description>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.
We performed an ancillary study to a multicenter double-blind, placebo-controlled randomized clinical trial of erythropoietin in ELGANs.
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.
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.</description><subject>acute kidney injury</subject><subject>Acute Kidney Injury - classification</subject><subject>Acute Kidney Injury - epidemiology</subject><subject>acute renal failure</subject><subject>Albuminuria - epidemiology</subject><subject>chronic kidney disease</subject><subject>Double-Blind Method</subject><subject>Erythropoietin - therapeutic use</subject><subject>Female</subject><subject>Gestational Age</subject><subject>Glomerular Filtration Rate</subject><subject>Humans</subject><subject>hypertension</subject><subject>Hypertension - epidemiology</subject><subject>Infant, Extremely Premature</subject><subject>Infant, Newborn</subject><subject>Infant, Premature, Diseases - epidemiology</subject><subject>Male</subject><subject>proteinuria</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Renal Insufficiency, Chronic - epidemiology</subject><issn>0022-3476</issn><issn>1097-6833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc1uEzEUhS0EomnhCZCQlyzqwT-TycyCRQmlVASKQlhbHs-dxpHHHmwPJbwkr4SbFJZIV_KV_Z1zfXUQesFowSirXu-K3QhdLDjlrKC5BHuEZow2C1LVQjxGM0o5J6JcVCfoNMYdpbQpKX2KToQo67Jqmhn6vdkCvh5GpRP2Pb4M-7QNfvQGknHYO_x160MiWLkOr7y7JRsIA_5oOgd7sgarEnT4ZkraDxBxlnwG7_JlPLj9TAEGsPssvcNXEJNKJj9bfHELBV5DnGw6kAp_yq3R4BKEc_zOT60F8tYa153jL1ZpaD1ZepeCtzZPXOf_-MH8yu0yQ0Znz00wyj5DT3plIzx_OM_Qt_eXm-UHsrq5ul5erIguaZmImrO-6puW9W3VaZjXmi9gLjgXWjSiVXXVMAW87htFeaX4ogRWN5VSnVKNVlScoVdH3zH471PeTA4marBWOfBTlLysaVnS-bzKqDiiOvgYA_RyDGZQYS8ZlfdJyp08JCnvk5Q0l2BZ9fJhwNQO0P3T_I0uA2-OAOQ1fxgIMmoDTkNnAugkO2_-O-APAiCzuw</recordid><startdate>20210501</startdate><enddate>20210501</enddate><creator>Askenazi, David J.</creator><creator>Schmicker, Robert H.</creator><creator>Brophy, Patrick</creator><creator>Comstock, Bryan A.</creator><creator>Wadhawan, Rajan</creator><creator>Baserga, Mariana</creator><creator>LaGamma, Edmund F.</creator><creator>Downey, L. 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Results of a Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial</title><author>Askenazi, David J. ; Schmicker, Robert H. ; Brophy, Patrick ; Comstock, Bryan A. ; Wadhawan, Rajan ; Baserga, Mariana ; LaGamma, Edmund F. ; Downey, L. Corbin ; Rao, Raghavendra ; Khan, Janine Y. ; Weiss, Michael ; Ohls, Robin ; Perez, Jorge E. ; Vu, Phuong T. ; Thomas, Billy ; Elhassan, Nahed ; Dydynski, Philip ; Mulrooney, Neil ; Yoder, Bradley ; Kase, Jordan S. ; Ramel, Sara ; Georgieff, Michael ; Gisslen, Tate ; Hall, Anne ; Johnson, Dana ; Kamrath, Heidi ; Hanson, Angela ; Satrom, Katherine ; Simones, Ann ; Plummer, Erin ; Zorn, Elizabeth ; Porta, Nicolas ; Rajderkar, Dhanashree ; Northington, Frances ; Beauman, Sandra ; Diaz-Barbosa, Magaly ; Serize, Arturo ; Mora, Ariana Franco ; Silvia, Amy ; Clopp, Bailey ; Feltner, John B. ; Esposito, Isabella ; Purnell, Andrea ; Loy, Emilie ; Sikes, Natalie ; Drake, Tammy ; Wright, Jocelyn ; Walden, Debra ; Nason, Jennifer ; Penny, Sarah ; Boles, Terri ; Kohlleppel, Katy ; Kaletka, Brian ; Worwa, Cathy ; Reich, Brixen ; Rau, Carrie ; Lewis, Kimberlee Weaver ; Giblin, Clare ; Daly, Rita ; Wassenaar, Jenna ; Obregon, Evelyn ; Wegner, Rachel E. ; Russow, Annamarie ; Barnhart, Lisa ; Galvis, Edshelee M. ; Bell, Suzi ; Westerveld, Michael ; Natarajan, Niranjana ; Gaudette, Shari ; Schumacher, Elizabeth ; Schuschke, Leslie ; Fierro, Mario ; Perdue, Nina ; Cunningham, Sean ; Stout, Kelly ; Cox, Lauren ; Hensley, Sarah ; Roberts, Dia ; Boys, Christopher ; Hultgren, Solveig ; Pierpont, Elizabeth I. ; Bataglia, Katherine ; Neis, Cathy ; Bergeron, Mark ; Accomando, Cara ; Gavin, Jennifer Anne ; Maczek, Elizabeth ; Smith, Vincent C. ; Weissbourd, Marie ; Matoba, Nana ; Heaton, Shelly C. ; Leppert, Mary ; Patel, Saurabh ; Chavis, Lacy ; Shannon, Jane ; Nefcy, Christopher ; Lowe, Jean R. ; Ballard, Roberta ; Janis, Scott ; O'Shea, Michael</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c404t-a51f6f9b1fb6dce58c27e53223c393ba8691ae28f9a026a274e1896aadaa9ca03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>acute kidney injury</topic><topic>Acute Kidney Injury - classification</topic><topic>Acute Kidney Injury - epidemiology</topic><topic>acute renal failure</topic><topic>Albuminuria - epidemiology</topic><topic>chronic kidney disease</topic><topic>Double-Blind Method</topic><topic>Erythropoietin - therapeutic use</topic><topic>Female</topic><topic>Gestational Age</topic><topic>Glomerular Filtration Rate</topic><topic>Humans</topic><topic>hypertension</topic><topic>Hypertension - epidemiology</topic><topic>Infant, Extremely Premature</topic><topic>Infant, Newborn</topic><topic>Infant, Premature, Diseases - epidemiology</topic><topic>Male</topic><topic>proteinuria</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Renal Insufficiency, Chronic - epidemiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Askenazi, David J.</creatorcontrib><creatorcontrib>Schmicker, Robert H.</creatorcontrib><creatorcontrib>Brophy, Patrick</creatorcontrib><creatorcontrib>Comstock, Bryan A.</creatorcontrib><creatorcontrib>Wadhawan, Rajan</creatorcontrib><creatorcontrib>Baserga, Mariana</creatorcontrib><creatorcontrib>LaGamma, Edmund F.</creatorcontrib><creatorcontrib>Downey, L. 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Academic</collection><jtitle>The Journal of pediatrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Askenazi, David J.</au><au>Schmicker, Robert H.</au><au>Brophy, Patrick</au><au>Comstock, Bryan A.</au><au>Wadhawan, Rajan</au><au>Baserga, Mariana</au><au>LaGamma, Edmund F.</au><au>Downey, L. Corbin</au><au>Rao, Raghavendra</au><au>Khan, Janine Y.</au><au>Weiss, Michael</au><au>Ohls, Robin</au><au>Perez, Jorge E.</au><au>Vu, Phuong T.</au><au>Thomas, Billy</au><au>Elhassan, Nahed</au><au>Dydynski, Philip</au><au>Mulrooney, Neil</au><au>Yoder, Bradley</au><au>Kase, Jordan S.</au><au>Ramel, Sara</au><au>Georgieff, Michael</au><au>Gisslen, Tate</au><au>Hall, Anne</au><au>Johnson, Dana</au><au>Kamrath, Heidi</au><au>Hanson, Angela</au><au>Satrom, Katherine</au><au>Simones, Ann</au><au>Plummer, Erin</au><au>Zorn, Elizabeth</au><au>Porta, Nicolas</au><au>Rajderkar, Dhanashree</au><au>Northington, Frances</au><au>Beauman, Sandra</au><au>Diaz-Barbosa, Magaly</au><au>Serize, Arturo</au><au>Mora, Ariana Franco</au><au>Silvia, Amy</au><au>Clopp, Bailey</au><au>Feltner, John B.</au><au>Esposito, Isabella</au><au>Purnell, Andrea</au><au>Loy, Emilie</au><au>Sikes, Natalie</au><au>Drake, Tammy</au><au>Wright, Jocelyn</au><au>Walden, Debra</au><au>Nason, Jennifer</au><au>Penny, Sarah</au><au>Boles, Terri</au><au>Kohlleppel, Katy</au><au>Kaletka, Brian</au><au>Worwa, Cathy</au><au>Reich, Brixen</au><au>Rau, Carrie</au><au>Lewis, Kimberlee Weaver</au><au>Giblin, Clare</au><au>Daly, Rita</au><au>Wassenaar, Jenna</au><au>Obregon, Evelyn</au><au>Wegner, Rachel E.</au><au>Russow, Annamarie</au><au>Barnhart, Lisa</au><au>Galvis, Edshelee M.</au><au>Bell, Suzi</au><au>Westerveld, Michael</au><au>Natarajan, Niranjana</au><au>Gaudette, Shari</au><au>Schumacher, Elizabeth</au><au>Schuschke, Leslie</au><au>Fierro, Mario</au><au>Perdue, Nina</au><au>Cunningham, Sean</au><au>Stout, Kelly</au><au>Cox, Lauren</au><au>Hensley, Sarah</au><au>Roberts, Dia</au><au>Boys, Christopher</au><au>Hultgren, Solveig</au><au>Pierpont, Elizabeth I.</au><au>Bataglia, Katherine</au><au>Neis, Cathy</au><au>Bergeron, Mark</au><au>Accomando, Cara</au><au>Gavin, Jennifer Anne</au><au>Maczek, Elizabeth</au><au>Smith, Vincent C.</au><au>Weissbourd, Marie</au><au>Matoba, Nana</au><au>Heaton, Shelly C.</au><au>Leppert, Mary</au><au>Patel, Saurabh</au><au>Chavis, Lacy</au><au>Shannon, Jane</au><au>Nefcy, Christopher</au><au>Lowe, Jean R.</au><au>Ballard, Roberta</au><au>Janis, Scott</au><au>O'Shea, Michael</au><aucorp>the PENUT Trial Consortium</aucorp><aucorp>PENUT Trial Consortium</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>The Journal of pediatrics</jtitle><addtitle>J Pediatr</addtitle><date>2021-05-01</date><risdate>2021</risdate><volume>232</volume><spage>65</spage><epage>72.e7</epage><pages>65-72.e7</pages><issn>0022-3476</issn><eissn>1097-6833</eissn><abstract>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.
We performed an ancillary study to a multicenter double-blind, placebo-controlled randomized clinical trial of erythropoietin in ELGANs.
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.
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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>33484699</pmid><doi>10.1016/j.jpeds.2021.01.031</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0022-3476 |
| ispartof | The Journal of pediatrics, 2021-05, Vol.232, p.65-72.e7 |
| issn | 0022-3476 1097-6833 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2480440556 |
| source | MEDLINE; Access via ScienceDirect (Elsevier) |
| subjects | acute kidney injury Acute Kidney Injury - classification Acute Kidney Injury - epidemiology acute renal failure Albuminuria - epidemiology chronic kidney disease Double-Blind Method Erythropoietin - therapeutic use Female Gestational Age Glomerular Filtration Rate Humans hypertension Hypertension - epidemiology Infant, Extremely Premature Infant, Newborn Infant, Premature, Diseases - epidemiology Male proteinuria Recombinant Proteins - therapeutic use Renal Insufficiency, Chronic - epidemiology |
| 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 |
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