A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64
A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64
Unnecessary and prolonged antibiotic therapy in newborn babies can have serious consequences
 including development of necrotizing enterocolitis (a serious, potentially life-threatening
 gastrointestinal illness in premature babies), late-onset infections, resistance to
 antibiotics, increased length of hospital stay, and death.

 Starting and continuing antibiotic therapy for blood culture-negative infections in the
 neonatal intensive care unit (NICU) is fairly common with numbers of such patients varying
 from 20%-90% of infants undergoing a sepsis evaluation in the NICU.

 While blood culture results are the gold standard, there is usually a delay of up to 48-72h
 before the results are known. Hence, initiation and continuation of antibiotic treatment are
 usually based on clinical evaluation and blood count criteria which do not possess high
 specificity or sensitivity, and may be unreliable in the first few hours after birth or in
 the early stages of infection.

 Since the investigators found that neutrophil CD64 (a type of protein found on the surface of
 a type of white blood cell that can be detected quickly in a very small amount of blood
 sample) has high accuracy for early detection of blood culture-proven infections in newborn
 babies, with extremely high negative predictive value (can identify babies definitively with
 no infection), the investigators will use this test to decide whether to stop or continue
 antibiotics in the NICU.

 The investigators hypothesis is that neutrophil CD64 values can be safely used to discontinue
 antibiotics in newborns suspected of having infections.

 The investigators aims are to utilize sequential measurements of CD64 values to stop
 antibiotics early in neonates being investigated for both early and late-onset infections in
 the NICU.

 This is a prospective, randomized, controlled (RCT) trial. The study population will be
 derived from the sub-set of all newborn infants who have undergone investigations for
 presence of infection in the NICU.
Inclusion Criteria:

 -  Infants undergoing a sepsis evaluation in the NICU

 Exclusion Criteria:

 -  They have a major life-threatening congenital malformation

 -  The attending neonatologist has objections to the infant participating in the study