
Burroughs Wellcome Fund's Presidential Award
Project Sponsor: Burroughs Wellcome Fund
Project Title: Catalyst Funding for Neonatal Nephrology RINK Research
Project Narrative:

Project Sponsor: Burroughs Wellcome Fund
Project Title: Catalyst Funding for Neonatal Nephrology RINK Research
Project Narrative:
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.