NCT02410486

Early-Onset Sepsis an NICHD/CDC Surveillance Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 570 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Not accepted

Summary

This prospective surveillance study will be conducted over a 2 year period to determine current rates of Early-Onset Sepsis (EOS)/ Early-Onset Meningitis (EOM), associated pathogens, antimicrobial resistance, signs and symptoms and infant outcomes.

Detailed description

Neonatal pathogens other than group B Streptococcus (GBS) and resistant to beta-lactam antibiotics have emerged as the most common etiologic agents of EOS and EOM among preterm and term neonates and result in high mortality rates, potentially offsetting the decreased burden of early-onset GBS disease prevented by maternal intrapartum chemoprophylaxis. Primary Outcomes of this study: 1. To determine current hospital-based rates of early-onset neonatal infection (total, GA-specific and BW-specific, and pathogen-specific) in term and preterm infants in the era of maternal intrapartum antibiotic prophylaxis to prevent vertical transmission of group B streptococcal disease. Early-onset infection comprises EOS and/or EOM and is defined as isolation of a pathogen from blood or cerebrospinal fluid (CSF) obtained within 72 hours of birth and provision of appropriate antibiotic treatment for 5 or more days (or \<5 days if death occurs while receiving antibiotic therapy). 2. To determine the antimicrobial susceptibility patterns of organisms associated with EOS and EOM The case control aspect of this study will address 2 major conundrums regarding EOS: Can we identify risk factors for early-onset Gram-negative infections that might lead to intervention strategies to reduce risk and can we identify infants born to mothers with clinical chorioamnionitis who are at highest risk for early-onset sepsis and thus warrant antibiotic treatment soon after birth?

Conditions

• Infant, Newborn, Diseases
• Early Onset Neonatal Sepsis
• Early-Onset Meningitis

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-04-07
• Last updated: 2019-03-11

Locations

20 sites across 1 country: United States