Late onset neonatal sepsis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Postnatal age in days (PNA) > 3. 2. It met the diagnostic criteria of LONS (according to the Expert Consensus on the Diagnosis and Treatment of Neonatal Sepsis (2019), Chinese Journal of Pediatrics, Vol. 57, No. 4, April 2019). (1) clinically diagnosed with clinical abnormalities, and meeting any of the following conditions: 1) >= 2 positive non-specific blood tests; 2) changes in cerebrospinal fluid as suppurative meningitis, and 3) DNA of pathogenic bacteria detected in blood. (2) The diagnosis was confirmed as clinical presentation, positive in blood culture or cerebrospinal fluid (or other sterile cavity fluid) culture. 3. Treatment with ceftriaxone sodium. 4. Written informed consent was signed by the parents or legal guardian of the neonate.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria shall not be admitted to this study: 1. The expected survival time may be shorter than the treatment cycle. 2. Severe congenital malformation. 3. Undergo surgery within the first week of birth. 4. Receiving other systemic experimental drug therapy. 5. There are other factors that researchers believe are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 70% fT>MIC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ceftriaxone treatment failure;Changes of white blood cell count (WBC), C-reactive protein (CRP) and procalcitonin (PCT);Blood culture results during administration;Incidence of adverse reactions; | — |
Countries
China
Contacts
Beijing Children's Hospital, Capital Medical University