The Research
In humans, the formation of brain structures and rapid brain growth starts early during pregnancy and continues for up to three years. In rats and mice, the comparable period of brain development is the first two weeks of life. In research studies, all of the anesthetics and sedatives commonly used in infants and children caused widespread loss of nerve cells and/or later abnormal behavior when administered during rapid brain growth in rodents. At this time, very limited data are available from studies of higher-level mammals, such as apes and monkeys. One study showed harmful effects to the nervous system in newborn monkeys given a commonly-used anesthetic.
For more information, see our KEY RESEARCH POINTS and FREQUENTLY ASKED QUESTIONS.
Filling the Gaps
SmartTots is committed to closing the research gaps related to the short-term and long-term effects of anesthetics on children. As funds become available, SmartTots will be looking to researchers in multiple scientific and medical fields to lead this vital research initiative.
Current Research
FDA Funded Projects
The FDA recently funded three projects related to SmartTots:
- Children's Hospital, Harvard University (Boston, MA), is conducting a long-term study of neurodevelopment outcomes in pediatric patients administered regional or general anesthesia as neonates or infants.
- Columbia University (New York, NY) is evaluating the effects of anesthetic exposure on neurocognitive, emotional and behavioral outcomes in pediatric patients.
- Mayo Clinic (Rochester, MN) is studying long-term cognitive development following exposure to general anesthetic agents during infancy.
National Center for Toxicology Research (NCTR)
The FDA's National Center for Toxicology Research (NCTR) is conducting non-clinical studies in non-human primates to assess 1) the mechanisms of neurotoxicity of clinically relevant sedatives such as ketamine, nitrous oxide, and isoflurane and 2) long-term developmental and learning effects related to exposure to these sedatives. In addition, the NCTR is investigating the development of noninvasive ways of using imaging to measure structural changes in the human brain.