PMID- 37419079 OWN - NLM STAT- MEDLINE DCOM- 20231023 LR - 20240322 IS - 1872-6232 (Electronic) IS - 0378-3782 (Print) IS - 0378-3782 (Linking) VI - 183 DP - 2023 Aug TI - Evaluation of neurovascular coupling during neuroprotective therapies: A single site HEAL ancillary study. PG - 105815 LID - S0378-3782(23)00111-1 [pii] LID - 10.1016/j.earlhumdev.2023.105815 [doi] AB - BACKGROUND: There is a critical need for development of physiological biomarkers in infants with birth asphyxia to identify the physiologic response to therapies in real time. This is an ancillary single site study of the High-Dose Erythropoietin for Asphyxia and Encephalopathy (Wu et al., 2022 [1]) to measure neurovascular coupling (NVC) non-invasively during an ongoing blinded randomized trial. METHODS: Neonates who randomized in the HEAL enrolled at a single-center Level III Neonatal Intensive Care Unit were recruited between 2017 and 2019. Neurodevelopmental impairment was blinded and defined as any of the following: cognitive score <90 on Bayley Scales of Infant Toddler Development, third edition (BSID-III), Gross Motor Function Classification Score (GMFCS) >/=1. RESULTS: All twenty-seven neonates enrolled in HEAL were recruited and 3 died before complete recording. The rank-based analysis of covariance models demonstrated lack of difference in NVC between the two groups (Epo versus Placebo) that was consistent with the observed lack of effect on neurodevelopmental outcomes. CONCLUSION: We demonstrate no difference in neurovascular coupling after Epo administration. These findings are consistent with overall negative trial results. Physiological biomarkers can help elucidate mechanisms of neuroprotective therapies in real time in future trials. CI - Copyright (c) 2023. Published by Elsevier B.V. FAU - Chalak, Lina F AU - Chalak LF AD - Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, United States of America. Electronic address: Lina.chalak@utsouthwestern.edu. FAU - Kang, Shu AU - Kang S AD - Department of Bioengineering, University of Texas at Arlington, Arlington, TX, United States of America. FAU - Kota, Srinivas AU - Kota S AD - Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, United States of America. FAU - Liu, Hanli AU - Liu H AD - Department of Bioengineering, University of Texas at Arlington, Arlington, TX, United States of America. FAU - Liu, Yulun AU - Liu Y AD - Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States of America. FAU - Juul, Sandra E AU - Juul SE AD - Division of Neonatology, Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, United States of America. FAU - Wu, Yvonne W AU - Wu YW AD - Department of Neurology, University of California San Francisco, San Francisco, CA, United States of America. LA - eng GR - P50 HD103524/HD/NICHD NIH HHS/United States GR - R01 NS102617/NS/NINDS NIH HHS/United States GR - U01 NS092764/NS/NINDS NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural DEP - 20230703 PL - Ireland TA - Early Hum Dev JT - Early human development JID - 7708381 RN - 11096-26-7 (Erythropoietin) RN - 0 (Biomarkers) SB - IM MH - Infant, Newborn MH - Infant MH - Humans MH - Asphyxia MH - *Neurovascular Coupling MH - *Asphyxia Neonatorum MH - Neuroprotection MH - *Erythropoietin/therapeutic use MH - Biomarkers MH - *Hypoxia-Ischemia, Brain/drug therapy PMC - PMC10824020 MID - NIHMS1959338 OTO - NOTNLM OT - Erythropoietin OT - Hypoxic ischemic encephalopathy OT - Neuroprotective therapy OT - Neurovascular coupling OT - Physiological biomarker COIS- Declaration of competing interest The authors have no conflicts or any competing interest to disclose. EDAT- 2023/07/08 10:42 MHDA- 2023/10/23 00:41 PMCR- 2024/01/29 CRDT- 2023/07/07 18:11 PHST- 2023/05/05 00:00 [received] PHST- 2023/06/26 00:00 [revised] PHST- 2023/06/27 00:00 [accepted] PHST- 2023/10/23 00:41 [medline] PHST- 2023/07/08 10:42 [pubmed] PHST- 2023/07/07 18:11 [entrez] PHST- 2024/01/29 00:00 [pmc-release] AID - S0378-3782(23)00111-1 [pii] AID - 10.1016/j.earlhumdev.2023.105815 [doi] PST - ppublish SO - Early Hum Dev. 2023 Aug;183:105815. doi: 10.1016/j.earlhumdev.2023.105815. Epub 2023 Jul 3.