Neonatal sepsis is a serious blood infection of the newborn. It is one of the most frequent causes of infant death and is the most common diagnostic work-up done in the neonatal intensive care unit (NICU). Because of the severity of complications from neonatal sepsis, more than 50% of infants admitted to the NICU receive a work-up to rule out neonatal sepsis—less than 2% of cases are true sepsis.⁹

The incidence of neonatal sepsis is highest in preterm infants, particularly low-birthweight infants (less than 1500 grams or 3 lbs., 5 oz.), as well as infants with depressed respiratory function at birth, and those with maternal perinatal risk factors.

Signs of neonatal sepsis are multiple and include diminished spontaneous activity, less vigorous sucking, apnea, bradycardia, temperature instability, respiratory distress, vomiting, diarrhea, abdominal distention, jitteriness, seizures and jaundice.

Early onset neonatal sepsis (EONS) occurs in the first week of life. The baby acquires the infection while in utero, most commonly from the setting of intraamniotic infection or from an ascending infection that occurs during labor and delivery. Eighty-five percent of newborns with early-onset infection present within 24 hours, 5% present at 24-48 hours and a smaller percentage of patients present between 48 hours and 6 days of life.¹⁰

For late onset neonatal sepsis, it is often not clear whether the source of infection is maternal or the nursery, e.g. contaminated hospital equipment.

Diagnosing neonatal sepsis is a clinical challenge with extensive laboratory testing required. Current diagnostic tests for neonatal sepsis include blood cultures, CBC and C-reactive Protein (CRP). Blood cultures are required for a definitive diagnosis and typically take 48 hours for results.

The urgent need to improve outcomes for these sick infants has caused many hospitals to treat for neonatal sepsis before a definitive diagnosis is made. Preterm infants are often treated prophylactically with antibiotics at birth, while tests are being conducted to rule in/rule out neonatal sepsis. While this is of essential benefit to those infants who are infected, it also means that preterm infants who are NOT infected are receiving antibiotic treatment—a situation that is contributing to subsequent antibiotic resistance resulting from overuse of these drugs.

ProteoGenix is working to help resolve this situation by developing non-invasive diagnostics that can help neonatologists rule out neonatal sepsis quickly and efficiently.