FAQFrequently Asked Questions
What is SmartTots?
SmartTots is a Public-Private Partnership (PPP) between the US Food and Drug Administration (FDA) and the International Anesthesia Research Society (IARS). The mission of this partnership is to coordinate and fund a research program with the goal of ensuring safe surgery for the millions of infants and young children who undergo anesthesia and/or sedation each year.
What is the International Anesthesia Research Society (IARS)?
Why was SmartTots launched?
How is SmartTots organized?
What is the National Center for Toxicological Research (NCTR)?
NCTR is an internationally recognized research center at the FDA that supports the goal of improving patient and consumer safety. NCTR, along with other centers at the FDA, conducts research to support the scientific basis for the FDA’s regulatory decisions and reduce risks associated with products regulated by the FDA. One of the ways that NCTR helps assess possible risks to human health is to perform animal research studies that investigate the potential for adverse effects and mechanisms of injury following exposure to potentially dangerous chemicals.
What did the animal studies show?
How did the concerns about the safety of anesthetic drugs for infants and young children arise?
The FDA’s National Center for Toxicological Research (NCTR), as well as investigators at several universities, conducted research to study the effects of anesthetics on the nervous systems of developing animals. This research demonstrated that exposure to some anesthetics and sedatives caused memory and learning difficulties and other harmful changes in the central nervous systems of some laboratory animals. Currently, inadequate data exist to prove or disprove whether similar effects occur in children. More information on the results of early animal studies is below.
Is there any other research being done?
SmartTots continues to facilitate and support studies of existing anesthetic drugs and their effects on childhood development, as well as the impact of drug type, dosage amounts and number of exposures. Information from these research studies will help to determine if particular anesthetic drugs pose hazards to young children, to design the safest anesthetic regimens (dose and duration), and potentially foster the development of new anesthetic drugs. SmartTots and the FDA are working closely to coordinate and fund future research programs with the goal of improving the safety of surgery.
Current studies include:
- Lena Sun, MD, Columbia University Medical Center, Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) Study
- Mary Ellen McCann, MD, MPH, Harvard Medical School, Boston Children’s Hospital, The GAS Study
- Jeffrey Sall, PhD, MD, University of California San Francisco, Recognition Memory Following Early Childhood Anesthesia
- Caleb Ing, MD, Columbia University, Anesthetic Exposure Duration and Effects on Cognitive and Language Ability
- Ansgar Brambrink, MD, PhD, Oregon Health & Science University, Long-Term Outcome of Single vs. Triple Anesthesia Exposure of Infant Monkeys
Additionally, SmartTots is working with an international team of expert neuroscientists to develop a clinical trial. Several other studies, independent of FDA, IARS and the SmartTots Public-Private Partnership, are also underway at major universities.
SmartTots is accelerating its efforts to fundraise to ensure that this important research continues. Learn how you can help at SmartTots.org/donate. Additional grant opportunities will be announced as funding becomes available.
Should we be concerned about risks to humans?
Is it harmful for infants and young children to undergo anesthesia?
What does this information really mean?
Where and when will the results from these studies be published?
Check back on our website for information regarding research funded by SmartTots, we will ensure updates occur as soon as new information becomes available. Press releases will be issued when research findings are published.
How many young children undergo surgery each year in the United States?
What are the most common conditions requiring surgery for that age group?
Are there alternatives to general anesthesia for surgery in young children?
Which of those conditions can be dealt with using regional anesthesia?
Should we postpone surgical procedures that require anesthesia for infants and young children?
What about the safety of anesthetic agents used to sedate newborns in the Neonatal Intensive Care Unit?
How can I obtain more information?
Parents of children who have undergone surgery or require surgery should consult with their primary care physician, surgeon/proceduralist and anesthesia professional.
How can I help?
SmartTots funds research necessary to make anesthesia safer for children around the world. Your donation will make a dramatic impact to help make this research possible. For your convenience, SmartTots has a number of giving options available – visit www.smarttots.org/donate/ for the option that best suits your needs.