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Design and rationale of the "Sedation strategy and cognitive outcome after critical illness in early childhood" study
Martha A Q Curley1, R Scott Watson2, Amy M Cassidy3
1From the School of Nursing, University of Pennsylvania, Philadelphia, United States; Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States; The Children's Hospital, Philadelphia Research Institute, Philadelphia, United States.
Insights
Sedatives given during critical illness may harm developing brains. The RESTORE-cognition study examines long-term neurocognitive outcomes in children exposed to sedatives, comparing them with healthy siblings.
Area of Science:
- Pediatric critical care medicine
- Neuroscience
- Developmental psychology
Background:
- Sedative medications are frequently used in pediatric intensive care units (PICUs).
- Concerns exist regarding potential neurotoxicity of sedatives during critical early brain development.
- Long-term neurocognitive effects of sedative exposure in critically ill children are not well understood.
Purpose of the Study:
- To investigate the relationship between sedative exposure during pediatric critical illness and long-term neurocognitive outcomes.
- To assess neurocognitive function in children 2.5-5 years post-hospital discharge.
- To compare outcomes between children exposed to sedatives and their healthy siblings.
Main Methods:
- Prospective cohort study design.
- Inclusion of up to 500 subjects aged 2 weeks to 8 years at PICU admission with normal baseline cognitive function.
- Neurocognitive function assessment at a single time point 2.5-5 years post-discharge.
- Inclusion of matched, healthy siblings as an unexposed control group.
Main Results:
- This paper focuses on the design and challenges of the RESTORE-cognition study.
- Highlights challenges in conducting comprehensive neurocognitive assessments across a wide age range and multiple centers.
- Details strategies for building interprofessional teams and cohort retention for longitudinal trials.
Conclusions:
- Understanding the impact of sedative exposure on neurodevelopment is crucial.
- The RESTORE-cognition study design provides a framework for future longitudinal research in this area.
- Novel approaches to cohort management are essential for successful long-term pediatric studies.
Abstract:
There is increasing concern that sedatives commonly used during critical illness may be neurotoxic during the period of early brain development. The Sedation strategy and cognitive outcome after critical illness in early childhood (RESTORE-cognition) study is a prospective cohort study designed to examine the relationships between sedative exposure during pediatric critical illness and long-term neurocognitive outcomes. We assess multiple domains of neurocognitive function 2.5-5 years post-hospital discharge, at a single time point and depending on participant and clinician availability, in up to 500 subjects who had normal baseline cognitive function, were aged 2 weeks to 8 years at pediatric intensive care unit admission, and were enrolled in a cluster randomized controlled trial of a sedation protocol (the RESTORE trial; U01 HL086622 and HL086649). In addition, to provide comparable data on an unexposed group with similar baseline biological characteristics and environment, we are studying matched, healthy siblings of RESTORE patients. Our goal is to increase understanding of the relationships between sedative exposure, critical illness, and long-term neurocognitive outcomes in infants and young children by studying these subjects 2.5 to 5 years after their index hospitalization. This paper highlights the design challenges in conducting comprehensive neurocognitive assessment procedures across a broad age span at multiple testing centers across the United States. Our approach, which includes building interprofessional teams and novel cohort retention strategies, may be of help in future longitudinal trials.