The Rhode Island Child Clinical Trials Collaborative (RI-CCTC) at Hasbro Children's Hospital, Women & Infants Hospital and Brown University will be an ideal clinical center for the ISPCTN. Our State demographic includes many underserved, minority and immigrant children, who have high rates of infant mortality, asthma, obesity, prematurity, mental health problems and special health care needs. This high risk population has not been previously included in many clinical studies; hence, they will benefit both directly and indirectly from the work of the RI-CCTC. Rhode Island is uniquely organized for population-based clinical research: it has one major obstetric hospital (70% of all deliveries in the state), one children's hospital (90% of all pediatric admissions in the state) and one health department, as well as an engaged community. These factors allow for effective enrollment, retention and follow-up of study participants in clinical trials, giving the RI-CCTC the potential to make a strong impact. We will leverage our rich network of collaborations with many existing research, education and public health programs, as well as affiliations with national research networks. These partners share our commitment to children's health and child health research. The Brown University School of Public Health and the Alpert Medical School, including the Departments of Pediatrics and OB/GYN, recently received a large gift to create the Hassenfeld Child Health Innovation Institute (HCHII), which is focused on understanding the prenatal, perinatal and postnatal factors that lead to childhood asthma, obesity and autism. Funding of the RI-CCTC will enable us to leverage the resources of the HCHII to create a much broader and more powerful research network to serve children in the state of RI. Investigators in the Schools of Public Health and Medicine have considerable expertise in the study of environmental exposures and their impact on children. The PI, Phyllis A. Dennery, has had consistent NIH funding for her basic/translational research, has participated in many training grants and multicenter clinical trials, and has won mentoring awards. The Co-PIs, Drs. Abbott Laptook and Thomas Chun, have been active participants in the NIH funded Neonatal Research Network and the Pediatric Emergency Care Applied Research Network. This team will ensure the success of the RI-CCTC in fulfilling the intent of the ECHO Program to investigate the longitudinal impact of pre-, peri-, and postnatal environmental exposures on pediatric health outcomes.
Our Specific Aims are to: 1) Provide new opportunities for patient enrollment in a national pediatric network through collaboration between academic research centers and institutions; 2) Leverage established strengths in public health and epidemiology to identify environmental exposures that will support the prospective trials of the ISPCTN; 3) Develop programs to educate and mentor clinicians and basic scientists to become independent investigators in the area of clinical research
The objective of the RICCTC is to create a network to advance the field of Pediatric Medicine by establishing and maintaining a network of academic centers that perform multi-center clinical protocols in a rigorous manner to investigate the safety and efficacy of treatment and management strategies to care for children. The state of Rhode Island offers a very diverse population of children for the requirements of the grant.