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PILOT STUDY PROTOCOL: APPLICATION OF MEASURES OF SPONTANEOUS MOTOR ACTIVITY FOR BEHAVORIAL ASSESSMENT IN HUMAN INFANTS
MCMASTER, S. B. AND J. HAMMOND. PILOT STUDY PROTOCOL: APPLICATION OF MEASURES OF SPONTANEOUS MOTOR ACTIVITY FOR BEHAVORIAL ASSESSMENT IN HUMAN INFANTS. U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-05/008, 2005.
As a participant in planning the National Childrens Study (NCS), EPA is interested in the investigation of key developmental disorders that may be associated with environmental exposures. This is particularly important in light of research that has established that prenatal and early childhood exposure to certain neurotoxicants including lead, mercury, manganese, and polychlorinated biphenyls (PCBs) can result in negative behavioral outcomes (Schettler, 2001). In some cases these outcomes are not clearly identified until children reach school age or later when the functionality of developmentally specific neurobehavioral processes is challenged. (Adams et al,, 2000; Rice & Barone, 2000). Given the plasticity of neurological systems affected by such exposures and their high level of vulnerability in the developing child, early detection is critical. The potential association between the relatively recent and large increase in the number of children diagnosed with conditions such as attention deficit-hyperactivity disorder (ADHD) and environmental factors is a public health issue of concern to the EPA. The goal of this research is to provide, for use in a large scale field study, a method to describe and quantitatively characterize spontaneous motor activity in four cohorts: infants (4-5 months & 6-12 months) and toddlers (13-18 months & 19-24 months). This protocol addresses two specific objectives: a) identification of sources of variance in infants and toddlers free living daily activity levels and estimation of the number of days of actigraphy measurement necessary for a reliable measure of these activities and b) investigation of the potential correlation between activity measures (e.g., counts/epoch) averaged over long periods of time and activity measures (e.g., counts/epoch) averaged over a specific play activity. This work continues the previous work assignment, WA 01-02, entitled Application of Measures of Spontaneous Motor Activity for Behavioral Assessment in Human Infants and
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Young Children to Predict Environmental Health and Safety Risks to Children for Use in Risk Evaluation. The current work assignment deliverable is a refinement of the previous protocol developed under WA 01-02. This refinement is a result of a review of all appropriate materials including any literature published in the previous 12 months, an update of accelerometer information including salient literature published in the previous twelve months and the identification and integration into the protocol of a non-linear movement patterns assessment appropriate for children between the ages of 0 and 24 months. In the statistical section of the protocol we were asked to review our previous power calculations and make appropriate modifications as well as review data analysis strategies in the literature and modify the previous protocol as appropriate. We have incorporated these requested tasks into this deliverable. We have addressed all the requirements of the work assignment, however there are two exceptions to WA 02-04 that should be noted. The WA specifically suggests four cohorts for this protocol, birth-5 months, 6-12 months, 13-18 months and 19-24 months. After a review of the literature and discussions with the WAM, it was determined that the first cohort should consist of children between the ages of 4 and 5 months. Specifically childrens sleep cycles have not been established before the age of 3 months which could introduce an unaccounted form of variability in the data. Second, after a careful review of the literature and discussions with the WAM, it was determined that the protocol would not be enhanced by the comparison of two accelerometers. Currrently the Actiwatch 64, recommended in our previous protocol, provides the sensitivity to collect data during both diurnal and nocturnal periods. This is a version of the Actical, made by Mini Mitter Co., currently used in other EPA studies.
The goal of this research is to provide, for use in a large scale field study, a method to describe and quantitatively characterize spontaneous motor activity in infants and toddlers
Record Details:Record Type: DOCUMENT (PUBLISHED REPORT/REPORT)
Organization:U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF RESEARCH AND DEVELOPMENT
NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LAB
HUMAN STUDIES DIVISION
EPIDEMIOLOGY AND BIOMARKERS BRANCH