About 80% of drugs labeled for adult use are either not FDA approved for children or have extensive off label use with inadequate dosing information. This has not improved in 20 years and can be corrected only by pediatric drug trials to meet FDA criteria for dose, indication and safety data. The NICHD Network of PPRU Program will provide resources for these trials. LSUMC-S participation in this program sets two goal. First, PPRU program objectives will be met by providing a resource to acquire data for FDA approved labeling and prescribing, and second, the LSUMC-S PPRU will expand to offer protocols as examples of our interest and capability in three categories of investigation: Network Collaboration, Industry Collaboration and Investigator Initiated Studies. For Goal #2, an administrative structure, budgeting and staff will enlarge the pediatric pharmacology program to fulfill its training mission to provide manpower for the PPRU. The LSUMC-S has he commitment of 23 investigator in six departments. The research plan design includes: 1. A description of a suitable clinical pharmacology with willing investigators, a clinical research facility, experienced principal investigator, evidence of industry collaboration, a core laboratory and data management resource, institutional commitments, local advisory committee, nurse coordinator and associate clinical pharmacologist; 2. A description of categorical protocols with include tramadol for pain, meperidine and midazolam for conscious sedation, ibuprofen or acetaminophen for fever, piperacillin and tazobactam for skin infections, erythromycin for infection in very low birth weight infants and ranitidine for gastroesophageal reflux; 3. A description of vignette protocols which include azithromycin, carbamazepine, oxybutynin, omeprazole and pentoxifylline for pediatric indications; 4. Integration of a clinical and basic science team approach to drug evaluation in children. The LSUMC-S PPRU research plan focuses on crucial pediatric pharmacotherapy issues to increase data for prescribing and FDA approval of labeling.
