Ongoing Studies for Clinical Trials

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Ongoing Studies for Clinical Trials as of November 2008

Awarded Grants – in Support of BPCA as of November 2008

Study:	Principal Investigator(s)	Institution:	Mechanism	Period of Performance
Morphine - Optimizing the Use of Morphine in Preterm Infants	JohnVan Den Anker, MD	Children’s National Medical Center	Grant HD048689	2005-2009
Azithromycin to prevent BPD in Ureaplasma-infected Preterms: Single Dose PK study	Rose M Viscardi, MD	University of Maryland	Grant 5R21 056424-02 revised	9/01/2007-08/31/2009 Single Dose PK study
Impact of Oseltamivir on Outcomes and Costs of Pediatric Influenza	Susan Coffin, MD	Children’s Hospital of Pittsburg	Grant 1R03HD055966-01	09/14/2007 – 08/31/2009
Pharmacogenetics of antenatal corticosteroids to improve neonatal outcomes	David Haas, MD	Purdue University at Indianapolis	Grant K23HD55305	2008-2011
Neonatal Morphine: Long-term Cerebrovascular Effects in Rats	Christine Gleason, MD	University of Washington	Grant 5R21DA022573-02	2008-2010
Development of mGluR5 Antagonists to Treat Fragile X Syndrome and Autism	Randall Carpenter, MD	Seaside Therapeutics, LLC	Grant 5 U01 MH78270-02 – co-funding to NIMH	10/08-09/2011

Contracts and Inter Agency Agreements for Pre-Clinical and Clinical Studies

Study	Principal Investigator	Institution	Mechanism	Period of Performance
Baclofen Oral treatment of spasticity for cerebral palsy	Jan Brunstrom , MD	Washington University	Contract 267200603421	2006-2011 Chart review complete; Pharmacokinetics (pk) trial starting in 2008; safety and efficacy trials pending
Daunomycin – Pharmacokinetics of Daunomycin in Children in children with cancer	Stacey Berg, MD	Children's Oncology Group through the National Cancer Institute	Inter-Agency Agreement	2004-2009
Hydroxyurea to Safety and Efficacy of Hydroxyurea in Young Children with Sickle Cell Disease		Partnership with the National Heart Lung & Blood Institute Phase III Clinical Trial Baby HUG	Inter-Agency Agreement	2005-2009 PK, efficacy and safety studies complete analysis underway. Bioequivalence study under development
Ketamine - Sedation - Pre-clinical toxicology studies.		Food and Drug Administration - National Center for Toxicological Research	Inter-Agency Agreement	2004-2009
Lorazepam for Sedation of Children in the Intensive Care Unit on Ventilators-	Jeff Blumer, MD	Case Western	Contract N01HD43367	2004-2009
Lorazepam for Treatment of Status Epilepticus	James Chamberlain, MD	Children's National Medical Center	Contract N01HD43393	2004-2009 Pharmacokinetics (PK) Study
Lithium for Treatment of Pediatric Mania	Robert Findling, MD	Case Western	Contract N01HD53406	2005-2009 Phase 1- Pharmacokinetics (PK) study; Phase 2- 8-week, randomized, placebo-controlled, double-blind study
Meropenem for complicated intra-abdominal infections in Infants	Danny Benjamin, MD, PhD	Duke University Danny Benjamin, MD, PhD	Contract 267200700051C	2007-2009 IND package submission 1/22/2008. PK study to start Spring 2008
Methotrexate and Neurocognition in Children with High-Risk Acute Lymphoblastic Leukemia		Children's Oncology Group through the National Cancer Institute	Inter-Agency Agreement	2004-2008
Methylphenidate - Evaluation of the effects of methylphenidate on cytogenetics in Children with Attention Deficit Hyperactivity Disorder (ADHD)		National Institute of Environmental Health Sciences and the Food and Drug Administration	Inter-Agency Agreement	2006-2010
Nitroprusside for Control of Blood Pressure	Scott Schulman, MD	Duke	Contract N01HD43385	2004-2009
Nitroprusside for Control of Blood Pressure	Gregory Hammer, MD	Stanford	Contract N01HD4338	2004-2009
Vincristine and Actinomycin-D - Safety Pharmacokinetics of treatment for malignancies in children		National Cancer Institute’s (NCI) Children’s Oncology Group (COG)	Inter-Agency Agreement	September 2004

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