Principal Investigator/Program Director (Last, First, Middle): BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME POSITION TITLE Mark S. Orlando, Ph.D., M.S. Associate Professor / Audiologist eRA COMMONS USER NAME EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) DEGREE (if applicable) YEAR(s) State University College at Buffalo B.S. 1984 Pennsylvania State University M.S. 1986 Communication Disorders Audiology University of Washington Ph.D. 1991 Audiology M.S. 2009 Business AdministrationMedical Management INSTITUTION AND LOCATION University Business of Rochester, Simon School of FIELD OF STUDY A. Personal Statement The goal of the proposed research is to evaluate if additional iron supplementation in premature infants with latent iron deficiency improves auditory neural myelination. I have the research training and clinical expertise in the key research areas of this application. For years I have used the auditory brainstem response procedure to indirectly evaluate both cochlear and auditory nerve function in young children. I have use the auditory brainstem response as a tool to measure the effects of maturation on full-term and preterm infants. My doctoral dissertation use the auditory brainstem response to compare the basilar membrane mechanics and motility in very young term infants. Since then, I’ve use the auditory brainstem response procedure to evaluate changes in the maturation and function of children under a variety of influences. Initial studies in collaboration with Dr. Sanjiv Amin at the University of Rochester Medical Center have focused on collecting normative data on very young pre-term infants 24 to 32 weeks just gestational age. These studies have been followed up with additional studies that compare the maturation effects of enteral feeding pipe (formula versus breastmilk), hyperbilirubinemia, iron and methylmercury to name just a few. For example, I have been involved with studies both at the University of Rochester and nationally setting up protocols and procedures, running up subjects, and scoring and analyzing data trying to determine the effects of hyperbilirubinemia on the maturing auditory system. Additionally I’ve been involved in studies with Cornell University looking at the effects of iron on fullterm newborns were born to teenage mothers. I have also been part of a large longitudinal cohort study between the University of Rochester Medical Center and the Republic of the Seychelles where we are trying to determine the long-term effects of low dose methylmercury exposure. The Seychelles cohort has been followed since mothers were early in pregnancy to now nearly 20 years later. During the course of testing we have used the auditory brainstem response along with otoacoustic omissions and a variety of other audiometric test procedures to determine the effects up exposure. In all these studies I have played an integral part of not only designing the study, running and coordinating the studies but also analyzing and participating in the dissemination of these investigations. In addition to be already mentioned investigations, I’ve spent considerable time both at the local and state level investigating the efficacy and effectiveness of newborn hearing screening across the state. The efficacy studies on newborn hearing screening were paramount for changes in state legislation implementing universal newborn hearing screening programs not only in New York State but many states across our nation. These few highlighted investigations hopefully we’ll show you not only my interest but also by dedication and enthusiasm in this research realm. I have worked with Dr. Sanjiv Amin and Dr. Gary Myers on similar projects over the past 15 years. Collectively we have been successful and productive looking at the development of the infant brain through the auditory brainstem pathway. PHS 398/2590 (Rev. 09/04) Page Biographical Sketch Format Page Principal Investigator/Program Director (Last, First, Middle): Davidson, Philip W. B. Positions and Honors: 1997-present Associate Professor, University of Rochester, Rochester, New York School of Medicine and Dentistry, Department of Otolaryngology 1994-present Audiology Discipline Coordinator, Strong Center for Developmental Disabilities, University Affiliated Program for Developmental Disabilities 1994-present Adjunct Assistant Professor, SUNY University of Buffalo, New York, Department of Communication Disorders and Sciences 1990-present Audiologist, Strong Audiology, Strong Memorial Hospital, Rochester, New York 1990-1997 Assistant Professor, University of Rochester, Rochester, New York, School of Medicine and Dentistry, Department of Surgery, Otolaryngology Division RECORD OF FELLOWSHIP AWARDS 1989-1990 1987-1989 1984-1985 Auditory Development, NIH Research Grant-Richard Folsom, University of Washington Computer Knowledge Based Systems, NIH Traineeship-Fred Minifie, University of Washington Pediatric Intervention, Dept. of Education Training Grant, Pennsylvania State University Honors 2009 Awarded Membership to the International Honor Society Beta Gamma Sigma a premier honor society for the best and brightest students in Business programs internationally C. Selected Peer-Reviewed Publications (15 from 22 peer-reviewed publications) Most Relevant to the current Application 1) Orlando, M.S. and Folsom, R.C. (1995). The effect of reversing the polarity of frequency-limited single-cycle stimuli on the human auditory brain stem response. Ear and Hearing, 16, 311-320. 2) Walton, J., Orlando, M.S., and Burkard, R. (1999). Auditory brainstem response forward-masking recovery functions in older humans with normal hearing. Hearing Research, 127, 86-94. 3) Amin, S., Orlando, M.S., Merle, K.S., Dalzell, L.E. and Guillet, R. (1999). Morphologic changes in serial auditory brainstem responses (ABRs) in 24-32-weeks’ gestational age infants during the first week of life. Ear in Hearing, 20, 410-418. 4) Davidson, P.W., Weiss, B., Myers, G.J., Cory-Slechta, D.A., Brockel, B.J., Carter Young, E., Orlando, M.S., Loiselle, D., Palumbo, D., Pittelli, R. and Sloan-Reeves, J. (2000). Evaluation of techniques for assessing Neurobehavioral development in Children. NeuroToxicology, 21(6), 957-972. 5) Amin, S., Ahlfors, C., Orlando, M.S., Dalzell, L., Merle, K., Guillett., R., (2001). Bilirubin and serial auditory brainstem responses in premature infants. Pediatircs, 107, 664-670. 6) Amin,S. B.; Merle,K. S.; Orlando,M. S.; Dalzell,L. E.; Guillet,R. (2000);. "Brainstem maturation in premature infants as a function of enteral feeding type". Pediatrics 106 (2000): 318-322. 7) Amin, S. B.; Orlando, M. S.; Dalzell, L. E.; Merle, K. S.; Guillet, R.;. "Brainstem maturation after antenatal steroids exposure in premature infants as evaluated by auditory brainstem-evoked response". J Perinatol 23 (2003): 307-311. 8) Davidson, P.W., Weiss, B., Myers, G.J., Beck, C., Cory-Slechta, D., Orlando, M.S., Loiselle, D, Young, E.C. and Sloane-Reeves, J. (2006). Development and Validation of test battery to assess subtle neurodevelopmental differences in children.. NeuroToxicology, 582, 1-19. 9) Amin, S.B., Orlando, M.S. Eddins, A., MacDonald, M., Monczynski, C. and Wang, H. (In Press). In Utero Iron Status and Auditory Neural Maturation in Premature Infants as Evaluated by Auditory Brainstem Response. The Journal of Pediatrics. PHS 398/2590 (Rev. 09/04) Page Continuation Format Page Principal Investigator/Program Director (Last, First, Middle): Davidson, Philip W. Additional recent publications of importance to the field 1) Spivak, L., Dalzell, L., Berg, A., Bradley, M., Cacace, A., Campbell, DeCristofaro, J., Gravel, J., Greenberg, E., Gross, S., Orlando, M., Pinheiro, J., Regan, J., Stevens, F. and Prieve, B. (2000). New York State Universal Hearing Screening Demonstration Project: Inpatient Outcome Measures. Ear and Hearing, 21, 92-103. 2) Prieve, B., Dalzell, L., Berg, A., Bradley, M., Cacace, A., Campbell, DeCristofaro, J., Gravel, J., Greenberg, E., Gross, S., Orlando, M., Pinheiro, J., Regan, J., Spivak, L., and Stevens, F. (2000). New York State Universal Hearing Screening Demonstration Project: Outpatient Outcome Measures. Ear and Hearing, 21, 104-117. 3) Dalzell, L., Orlando, M., MacDonald, M. L., Berg, A., Bradley, M., Cacace, A., Campbell, DeCristofaro, J., Gravel, J., Greenberg, E., Gross, S., Orlando, M., Pinheiro, J., Regan, J., Spivak, L., Stevens, F., and Prieve, B. (2000). New York State Universal Hearing Screening Demonstration Project: Age of hearing loss identification, hearing aid fitting and enrollment in early intervention. Ear and Hearing, 21, 118-130. 4) Liptak, G.S., Orlando, M.S., Yingling, J., Kaufman-Theurer, K., Malay, D., Tompkins, L., and Flynn, J. (2005). Satisfaction with primary health care received by families of children with developmental disabilities. Journal of Pediatric Heath Care, 20, 245-252. 5) Nolan, K.W. , Orlando, M.S. and Liptak, G.S. (2007). Care coordination services for children with special health care needs: Are we family-centered yet? Families, Systems and Health. 25, No 3, 293-306. D. Ongoing Research Support USDA 2008-01857 Guillet, R and O’Brien, K (Co-PI) 12/08-11/11 Title: Impact of Maternal Iron Status on Neonatal Iron Status and Auditory Brainstem Response in Newborn Role: Audiology Project Coordinator/Co Investigator The primary goal of this investigation is to determine the effects low maternal iron levels on the full term newborn infants. Amin, S (PI) 2/2006-9/30/11 NIH 5K23DC006229-02 Title: Bilirubin Induced Auditory Neuropathy in Preterm and Term infants Role Audiology Project Coordinator/Co-Investigator The primary goal of this study is to evaluate the prevalence of bilirubin-induced auditory dys-synchrony and compare bilirubin-albumin binding variables as predictors of bilirubin-induced auditory dys-synchrony in premature infants less than or equal to 33 weeks GA infants. DHHS/MCHB T73 MC 0002907 Sulkes, S (PI) 7/2006- 6/2011 Renewal of MCH Inter-disciplinary UAP Leadership Training Title: Interdisciplinary Leadership Education in Neuro-developmental and Related Disabilities Source: The Department of Health and Human Services, Maternal and Child Health Bureau Role Co-investigator and Audiology Discipline Coordinator This grant is a leadership training grant teaching fellows in a variety of 15 disciplines leadership training as it relates to children with chronic and related neurodevelopmental disabilities. NIH 3RO1E008442-06S1A1 Davidson,P (PI) 10/2008-9/2011 Title: Methyl Mercury Effects on adolescent Development Role: Audiology project Coordinator The goal of this grant is to determine the long term effects of low level methyl mercury exposure in a longitudinal cohort study in conjunction with the republic of the Seychelles. PHS 398/2590 (Rev. 09/04) Page Continuation Format Page