Clinical and Epidemiologic Research

Established in 2003, and directed by Dr. Moss, the Yale Center for Children’s Surgical Research (YCCSR) affirms the core values of the Pediatric Surgery section. Under its umbrella, widely diverse, evidence-based, multi-center studies are conducted. A full-time research coordinator assists in the preparation of applications for new funding opportunities, ensures that regulatory requirements for human research are met and that studies are conducted in the highest ethical manner.

The YCCSR continues to play a leadership role in the kind of multi-institutional research necessary to learn about rare diseases. Currently, Yale is the lead and coordinating center for a robust and active multi-center research cooperative network which studies necrotizing enterocolitis (NEC) that includes Children’s Hospital of Philadelphia, Johns Hopkins Children’s Hospital, Texas Children’s Hospital, and Packard Children’s Hospital at Stanford University. Using this network, we recently completed the largest prospective study of infants at risk for NEC which has ever been done. The extensive NEC database is a rich resource for researchers and we expect to generate a plethora of original articles; the first was published in the Journal of Perinatology in 2008.

Because one of our major interests is the fight against necrotizing enterocolitis (NEC), our research network has recently designed and undertaken a study which will use high throughput molecular analysis to better understand which babies are at risk for necrotizing enterocolitis and which affected babies will suffer the most severe form of the disease. Using recently developed techniques, we will be able to take less than a single drop of blood from these infants and analyze tens of thousands of proteins and genes in order to better understand this disease. We have already completed the pilot phase of this important study and are now moving towards wider implementation. Our NEC study has attracted the attention of a major pharmaceutical company that plans to partner with us and provide support for completion of this study on a national scale. We believe that our efforts will ultimately have a significant impact in ameliorating the effects of this disease. This type of industry partnership in clinical research, when properly designed and executed, can result in significant research support and help novel products and ideas reach patients in a timely manner.

Another interest of our clinical research group is the impact of a patient’s financial status on quality and access to medical care. We have recently completed a nationwide study of infants born with major congenital anomalies requiring surgery, the focus on how and where these infants were managed. We found that infants without medical insurance or other financial resources were rapidly transferred to major children’s hospitals for definitive care. However, insured infants were more likely to be treated in the community hospital setting with transfer to the children’s hospital occurring late or not occurring at all. This has the paradoxical effect of keeping the infants with the greatest amount of financial resources at the centers which were least experienced in providing tertiary care. This system of skewed incentives has two effects: 1) it results in a disparity of the care delivered based upon economic forces, 2) it produces a markedly disproportionate burden on children’s hospitals for the provision of tertiary care. This burden reduces the resources available to children and has a negative effect on the system of children’s care in the United States. These findings will be presented at the American Pediatric Surgical Association (APSA) in 2009.

Our clinical research group has completed multiple additional research projects which are too numerous to mention. The program is healthy and thriving and is producing trained research fellows on a yearly basis. Current pediatric research efforts are supported both by National Institutes of Health and private foundations. The John Seashore Pediatric Surgery Research Fellowship, established in 2004 on the retirement of Dr. John Seashore (’73 -‘04), provides office space and financial support for a surgeon or surgical resident in order to conduct research for a two-year period. We are particularly proud of our association with the Robert Woods Johnson Clinical Scholars Program. This is arguably the most prestigious clinical research training program in the country. Individuals who receive research training in the YCCSR will go on to careers in academic children’s surgery and become principal investigators of their own research efforts.