The University of Rochester proposes to participate in the NICHD Collaborative Neonatal Research Network This Network was formed 15 years ago to develop reliable scientific evidence for best clinical practice. By combining the populations of many intensive units, sufficient sample sizes of adequate diversity are enrolled in a reasonable time frame. The Network also collects prospective observational data for pilot projects, calculating sample sizes, and identification of key issues for future studies. Efforts are coordinated with a parallel Maternal-Fetal Medicine Network, and success and productivity relies on the creativity, design skills, experience and dedicated work of the center principal investigators that make up the Steering Committees, and the dedicated research staff that conduct the trials and collect the data. Dale L. Phelps brings a wealth of personal experience in designing and conducting neonatal multi-center randomized trials. In addition, the other 10 academic faculty have also been conducting multi-center randomized trials and basic research for 18+ years, while caring for the 1200 NICU admissions annually. They work closely with the Maternal-Fetal Medicine Division as the Regional Perinatal Center with established maternal transport of known high risk pregnancies, ensuring a stable population for recruitment. The NICU Follow-up Program evaluates all NICU graduates meeting high risk criteria (-20%), plus all infants in research protocols. In addition, all NICU graduates (high risk or not) are tracked via mailed annual questionnaires to families and physicians through age 5 years. Over 93% follow up has been accomplished for enrolled research subjects in follow up studies to date. The Children?s Hospital at Strong Perinatal Center at the University of Rochester has a large diverse neonatal population, experienced investigative faculty, and an outstanding Medical Research Institute. This center will be an outstanding participating Network Center. Dale Phelps as the PI, will be a dedicated participant and contributor on the Steering Committee and working subcommittees.

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 #
5U10HD040521-03
Application #
6615685
Study Section
Special Emphasis Panel (ZHD1-MCHG-B (10))
Program Officer
Higgins, Rosemary
Project Start
2001-05-01
Project End
2006-03-31
Budget Start
2003-04-01
Budget End
2004-03-31
Support Year
3
Fiscal Year
2003
Total Cost
$355,463
Indirect Cost
Name
University of Rochester
Department
Pediatrics
Type
Schools of Dentistry
DUNS #
041294109
City
Rochester
State
NY
Country
United States
Zip Code
14627
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(2016) Pharmacokinetics and safety of a single intravenous dose of myo-inositol in preterm infants of 23-29 wk. Pediatr Res 80:326

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