Project Sponsor: NIH/NIDDK
Project Title: Acute Renal Injury Sequelae in NICU Graduates (ARISING)
Neonates admitted to the neonatal intensive care unit commonly develop neonatal acute kidney injury (nAKI), which leads to death, prolonged hospitalization and perhaps chronic kidney disease (CKD). The project's central purpose is to bridge fundamental knowledge gaps in the field by determining the attributable risk of nAKI on CKD, and providing reliable and precise methods to diagnose nAKI and predict CKD early in life. At the conclusion of the study, clinicians' abilities to care for neonates and researchers' ability to conduct intervention studies designed to improve outcomes in those at risk of nAKI will be greatly enhanced.
- Secondary analyses of the PENUT/Repaired Study
Project Sponsor: Nuwellis
Project Title: The ALMOND Studies – “Assessing Longitudinal Micropremie Outcomes in Neonates at risk for renal Disease”
Project Narrative: The Preterm Erythropoietin Neuroprotection Trial (PENUT) is an NIH-NINDS funded clinical trial that evaluated neurocognitive outcomes in extremely low gestational age neonates (ELGANS) randomized to recombinant erythropoietin (EPO) vs. placebo (clinicaltrials.gov identifier is NCT01378273). From this trial: EPO was found to be safe, but did not impact the primary outcome (mortality or neurocognitive deficit at 22-26 mo GA).
The Recombinant Erythropoietin for Protection of Infant Renal Disease (REPaIReD) study is an NIH NIDDK ancillary study designed to evaluate whether EPO improved or worsened short and long-term kidney outcomes in ELGANS. The REPaIReD group published on the prevalence of AKI and has recently reported that EPO was associated with higher systolic blood pressure at 2 year corrected gestational age, but did not find evidence of other short and long-term differences in kidney outcomes between groups. Additional analyses have been performed and reported in abstract form at multiple international meetings.
This cohort of 923 ELGANS (which included an equal number of subjects in the 24, 25, 26, and 27 week + cGA categories) are characterized very well. Multiple urine biomarkers have been analyzed at multiple timepoints during the NICU stay and at the 2 year timepoint. Serum creatinine AKI occurred in about 2 out of 5 neonates, using a large number of SCr values obtained as part of clinical care during the first month postnatal. Kidney outcome specific data obtained at the 2 year visit includes blood (eGFR calculated from SCr/Cystatin C equation), blood pressure, spot urine protein/creatinine, and urine biomarkers.
The ALMOND studies seek to utilize this data to continue to answer questions related to neonatal kidney disease.
Additional AWAKEN Support
- Cincinnati Children’s Hospital Center for Acute Care Nephrology provided funding to create and maintain the Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates (AWAKEN) study Medidata Rave electronic database.
- The Pediatric and Infant Center for Acute Nephrology (PICAN) provided support for web meetings and for the Neonatal Kidney Collaborative (NKC) steering committee annual meeting at The University of Alabama at Birmingham (UAB). PICAN is part of the Department of Pediatrics at UAB and is funded by Children’s of Alabama hospital, UAB Department of Pediatrics, UAB School of Medicine, and UAB Center for Clinical and Translational Sciences (National Institutes of Health grant UL1TR001417).
- The University of New Mexico involvement in AWAKEN was supported by the Clinical and Translational Science Center at The University of New Mexico (National Institutes of Health grant UL1TR001449) and by The University of Iowa Institute for Clinical and Translational Science (grant U54TR001356).
- The AWAKEN study investigators at the Canberra Hospital at the Australian National University Medical School were supported by the Canberra Hospital Private Practice Fund
- Investigators at University of Virginia Children’s Hospital were supported by a 100 Women Who Care Grant from the 100 Women Charitable Foundation