 a. Review of InclusionExclusion Criteria prior to infant enrollment b. Obtain signed and dated informed consentHIPAA consent. c. Collect demographic data and medical history d. Perform a complete physical examination e. Obtain and record infant weight and medication dosing weight for calculation of appropriate study drug dose if different from actual weight f. Record results from hematology and serum chemistry labs if obtained within 72 hours prior to enrollment in accordance with local standard of care. Use the laboratory values closest to enrollment if there have been multiple tests. 