This R34 application describes a planning grant (hereafter called the """"""""R34"""""""") that will develop the Manual of Procedures (MOP) and put the systems in place so we could successfully implement and complete the full Pediatric Anesthesia Neurodevelopment Assessment (PANDA) study (the """"""""Full PANDA Study""""""""). The funding for the Full PANDA Study will be sought later through a regular R01 application. We will use the same study procedures in the R34 as we propose for the Full PANDA Study to optimize operational logistics. We will also use the R34 to develop the study infrastructures for data management and neuropsychological testing and consolidate the network of study sites for the Full PANDA Study. We will conclude with a Study Protocol Workshop to finalize the MOP for the Full PANDA Study. The Full PANDA Study will address the critical public health issue of the neurodevelopment effects of limited anesthesia exposure in healthy infants. The study design was the effort of an interdisciplinary and experienced team of investigators, all of whom will continue as active key investigators in the Full PANDA Study. The proposed Full PANDA Study design involves prospective neuropsychological assessment of a historic cohort of infants who had hernia surgery prior to 36 months of age. This is both efficient and cost-effective, because once we have identified the study subjects, and confirmed their eligibility, and they have agreed to participate in the study, the study procedures involve a single session of neuropsychological testing during which all data collection pertaining to the study subject and his/her sibling will be completed. There will be no attrition from loss to follow up and the Full PANDA Study would be completed within a predictable timeline. The Full PANDA Study results will be clear, interpretable and have wide applicability, since healthy infants with limited anesthesia exposure during elective procedures constitute the largest group of children receiving anesthesia. The results from the Full PANDA Study will therefore have a large and significant impact on child health in a reasonable time and at reasonable cost. During the R34, we plan to identify, recruit, schedule and test 10 sibling pairs to evaluate and optimize operational logistics of our study procedures. We will use the R34 planning grant to put in place all essential elements of the infrastructure for the Full PANDA Study. We will finalize the total number of study sites needed. We will establish the neuropsychological testing core that will ensure the testing performed at different sites produce results with reliability, reproducibility and constancy across sites, thus providing confidence in the study's validity. We will develop the data management structure that would allow us to enter, retrieve and analyze data effectively and reliably. Finally, we plan to have a Study Protocol Workshop that will finalize the study protocol which would be ready for immediate implementation as soon as the PANDA study begins. The systems put in place with the R34 will allow us to successfully implement the Full PANDA Study, and enable us to complete the study in a predictable, timely and cost effective manner.
The planning activities outlined in the revised R34 application are to develop and finalize the Manual of Procedures (MOP) for the future large scale multi-site Pediatric Anesthesia Neurodevelopment Assessment (PANDA) study (the Full PANDA Study). The systems and infrastructure put in place with the R34 will allow us to successfully implement and complete the Full PANDA Study in a predictable, timely and cost-effective manner. The Full PANDA Study will be submitted as a R01 application.
|Sun, Lena S; Li, Guohua; Miller, Tonya L K et al. (2016) Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA 315:2312-20|
|Sun, Lena S; Li, Guohua; DiMaggio, Charles J et al. (2012) Feasibility and pilot study of the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) project. J Neurosurg Anesthesiol 24:382-8|
|Byrne, Mary W; Ascherman, Jeffrey A; Casale, Pasquale et al. (2012) Elective procedures and anesthesia in children: pediatric surgeons enter the dialogue on neurotoxicity questions, surgical options, and parental concerns. J Neurosurg Anesthesiol 24:396-400|
|Sun, L (2010) Early childhood general anaesthesia exposure and neurocognitive development. Br J Anaesth 105 Suppl 1:i61-8|
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