A New Horizon for Understanding the Comparative Effectiveness for Cooling Prospectively Infants with Mild Encephalopathy - 01/08/24

Doi : 10.1016/j.clp.2024.04.003

Lina F. Chalak, MD, MSCS ^a,^⁎ , Jonathan L. Slaughter, MD, MPH ^b, Wendy C. King, PhD ^c, Pollieanna Sepulveda, BS, MSN ^a, Stephen R. Wisniewski, PhD ^d
^a Department of Pediatrics, Neonatal-Perinatal Medicine, University of Texas Southwestern Medical School, 5323 Harry Hines Boulevard, Dallas, TX 75390-9063, USA
^b Department of Pediatrics and Epidemiology, Center for Perinatal Research, Nationwide Children’s Hospital, Colleges of Medicine and Public Health, The Ohio State University, 575 Children’s Crossroad, Columbus, OH 43215, USA
^c Department of Epidemiology, School of Public Health, University of Pittsburgh, Pittsburgh, PA 15260, USA
^d Department of Epidemiology, School of Public Health, Vice Provost for Budget and Analytics, University of Pittsburgh, Pittsburgh, PA 15260, USA

^∗Corresponding author.

Résumé

The authors summarize the methodology for a new pragmatic comparative effectiveness research investigation, Cooling Prospectively Infants with Mild Encephalopathy (COOLPRIME), which uses sites’ existing mild hypoxic-ischemic encephalopathy (HIE) treatment preference (hypothermia or normothermia) to assess hypothermia effectiveness and safety. COOLPRIME’s primary aim is to determine the safety and effectiveness of hypothermia compared to normothermia in mild HIE. Engagement of Families and Community Affected by Hypoxic-Ischemic Encephalopathy strongly favored Effectiveness over Efficacy Trials leading to COOL PRIME design.

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Keywords : Asphyxia, Mild hypoxic-ischemic encephalopathy (HIE), Neonate, Therapeutic hypothermia, Neurodevelopment, Comparative effectiveness research (CER), Target trial emulation

Plan

Key points

Introduction

Engagement of Families and Community Affected by Hypoxic-Ischemic Encephalopathy Is Central to Cooling Prospectively Infants with Mild Encephalopathy

Study Design Options with Stakeholders Favored Effectiveness over Efficacy Trials

Study Design Options with Stakeholders Favored site randomization observational design over standard randomization

Methods

Screening Process and Procedures

Eligibility Criteria

Treatments

Neurocognitive Outcomes

Secondary Cooling Prospectively Infants with Mild Encephalopathy Studies

Sample Size

Analysis Approach

Summary

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Vol 51 - N° 3

P. 605-616 - septembre 2024 Retour au numéro

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Hypothermia for Hypoxic-ischemic Encephalopathy : Second-generation Trials to Address Gaps in Knowledge
Abbot R. Laptook, Seetha Shankaran, Roger G. Faix

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Key Inflammatory Biomarkers in Perinatal Asphyxia : A Comprehensive Review
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A New Horizon for Understanding the Comparative Effectiveness for Cooling Prospectively Infants with Mild Encephalopathy - 01/08/24

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