Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
0–0
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent obtained from parent or legal guardian
Birth weight 500 to 1250 g, inclusive
Age 3 - 5 days (49 to 120 hours), inclusive
Expected to require IV access for medical care through day of life 14
You may not be if
Already received or likely to receive prior to first infusion of Study Drug:
* IGIV or \*immune globulin for prevention of Hepatitis B
Receiving an agent for prevention of staphylococcal catheter related or nosocomial infections (e.g., vancomycin)
Active sepsis, as defined by one of the following:
* culture proven early onset sepsis and not clinically stable; or
* clinical signs of sepsis and pending blood cultures; if the blood cultures are negative after 48 hours and the infant is clinically stable, the infant may be randomized
Severe congenital anomaly, where the prospects for survival, the medical complications and treatment, would compromise the study related outcome evaluation(s) in the Investigator's opinion
Diagnosis of congenital immunodeficiency
Evidence of significant fluid overload or significant volume depletion
Evidence of abnormal renal function as measured by serum creatinine \> 1.6 mg/dL
