SOURCE: SmartTots


March 09, 2011 17:48 ET

SmartTots to Lead Pediatric Research Initiative

A Collaborative, Multidisciplinary Approach to Determine the Effects of Anesthetics on the Developing Brain

SAN FRANCISCO, CA--(Marketwire - March 9, 2011) - Anesthetic drugs administered during sensitive periods of brain development may cause adverse effects, according to an article published today in the New England Journal of Medicine (NEJM). Studies conducted in both rodents and nonhuman primates show that exposure to anesthetics under certain circumstances during the developmental period can cause cell death leading to cognitive deficits later in life. Evidence to support or refute whether these results are translatable to humans does not exist. SmartTots, a multidisciplinary pediatric research foundation, has been created to address the research gaps related to the effects of anesthetics on the developing human brain.

SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots) is the result of a public-private partnership between the International Anesthesia Research Society (IARS) and the U.S. Food and Drug Administration (FDA). In collaboration with multiple stakeholders, SmartTots is supporting further research related to anesthetic-induced neurotoxicity, including identifying questions to be answered, finding researchers to conduct necessary studies, and raising funds to support those studies.

"It is the goal of SmartTots to create an appropriate scientific research plan, and then provide adequate resources so we can determine the safest anesthetic techniques for children," said James Ramsay, MD, Chair of the IARS Board of Trustees and Co-Chair of the SmartTots Steering Committee.

The FDA will convene an Anesthetic and Life Support Drugs Advisory Committee on Thursday, March 10 to discuss findings from recent studies, including the relevance and impact of these findings on humans. Following the FDA meeting, SmartTots will finalize and implement their research agenda and initiate fundraising to support additional research studies. Definitively determining whether anesthetics pose harmful effects on the developing brain will likely take years of animal and human studies, as well as the expertise and resources of numerous individuals and organizations.

"At the current time there is no definitive evidence that anesthetics cause damage to the central nervous system of children," said Alex S Evers, MD, SmartTots Scientific Advisory Board Co-Chair. "However the compelling evidence that anesthetics cause brain injury in newborn animals makes it imperative that we determine whether adverse effects do occur in children under the age of four and, if so, under what circumstances."

"SmartTots will teach us how to give anesthesia and perform surgery absolutely safely for children under the age of four," said Mike Roizen, MD, Chair of the SmartTots Executive Board.

About SmartTots
SmartTots, formerly known as SAFEKIDS, is a Public-Private Partnership between the U.S. Food and Drug Administration (FDA) and the International Anesthesia Research Society (IARS) designed to close research gaps relating to the effects of anesthetics on the developing human brain, and ensure the safety of infants and toddlers undergoing anesthesia in surgical procedures. Findings from research supported by SmartTots will determine the safety of commonly used anesthetics, establish new practice guidelines, and encourage the development of safer anesthetics and sedatives. For more information, visit

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