The Wayne State University School of Medicine (WSU) is submitting an application for renewal in the NICHD Multicenter Neonatal Research Network (NRN) with the objective of improving the health of high risk infants. The Specific Alms of the WSU site are the following:
Specific Aim 1 : conduct randomized controlled trials (RCT) to improve the care of high risk infants.
Specific Aim 2 : perform observational studies and long term follow-up to assess outcome of high risk infants and Specific Aim 3: To disseminate results of research in order to facilitate the development and practice of evidence based medicine. WSU has taken the lead with the PI, Seetha Shankaran, as the Network Study PI in the upcoming NRN trial: Optimizing Cooling as Neuroprotection for Term Infants with Hypoxic-Ischemic Encephalopathy with study training conducted by the WSU team in May 2010. WSU Alternate PI, Dr. Beena Sood, has taken the lead in the study evaluating Inhaled Prostaglandin El for Neonatal Hypoxic Respiratory Failure. This study is pending FDA approval. Based on WSU experience with evaluating brain injury in ELBW infants, WSU site Follow-UP PI, Dr. Athina Pappas has submitted a concept protocol in this application on Erythropoietin as Neuroprotection for Neonatal Intracranial Hemorrhage among ELBW Infants. Dr Shankaran will continue to encourage WSU site personnel to submit protocols to the NRN. Dr Pappas plans to evaluate the role of anesthesia and surgery in contributing to the outcome of ELBW infants participating in the ongoing NRN RCT of Laparotomy versus Drain for Necrotizing Enterocolitis or Isolated Intestinal Perforations and Dr. Sood will examine mesenteric blood flow using the innovative technique of near-infra red spectroscopy (NIRS) among trial participants. The WSU site developed Guidelines for Whole Body Hypothermia for Neonatal HIE;these are available on the public website of the NRN. The WSU team will continue to publish NRN studies and present data at scientific meetings. WSU added a satellite site at the University of Michigan (UM) in May 2010. The WSU site has an Inborn service at Hutzel Women's Hospital (5500 births, 55 bed NICU) and an outborn service at Children's Hospital of Michigan (35 bed NICU). The UM site has 3700 births and a 40 bed NICU. WSU has the goal to include Spectrum Health in Grand Rapids Ml as an additional satellite site in the coming year so that results of trials and observational studies can be disseminated on an on-going manner throughout the state.

Public Health Relevance

The WSU site will perform the WSU led RCT and Observational studies noted under the Project Summary and participate in all Network Studies so that the care of high risk neonates can be enhanced, and the mortality rate and rate of neurodevelopmental and cognitive impairments can be reduced. The public heath impact will be a reduction of psychosocial and medical costs to families and society.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10HD021385-26
Application #
8081431
Study Section
Special Emphasis Panel (ZHD1-DSR-A (03))
Program Officer
Higgins, Rosemary
Project Start
1991-04-01
Project End
2016-03-31
Budget Start
2011-04-01
Budget End
2012-03-31
Support Year
26
Fiscal Year
2011
Total Cost
$303,880
Indirect Cost
Name
Wayne State University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
001962224
City
Detroit
State
MI
Country
United States
Zip Code
48202
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