Health Condition 1: A00-B99- Certain infectious and parasitic diseases
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Jawaharlal Nehru Medical College KLE University Belagavi
Eligibility
Inclusion criteria
Inclusion criteria: Neonates age greater than 72 hrs and less than or equal to 28 days of life with culture-positive late onset sepsis (LOS) And or Or Neonates aged greater than 72 hours with Culture-negative LOS Culture-negative LOS is defined as CRP level greater than 10 mg per L at the time of evaluation or antibiotic therapy longer than 5 days (or intention to treat longer for late onset sepsis ) or clinical symptoms of sepsis
Exclusion criteria
Exclusion criteria: 1)Presence of antibiotic exposure for more than 48 hours before the LOS (Late Onset Sepsis ) episode evaluation 2)Early-onset sepsis (less than or equal to 72 hr) 3)Major congenital anomalies (major congenital heart disease, central nervous system malformations, gastrointestinal atresias or abdominal wall defects, congenital diaphragmatic hernia or pulmonary hypoplasia, severe renal anomalies, inborn errors of metabolism, multisystem syndromic anomalies and others) 4)Chromosomal abnormalities (Numerical abnormalities: Trisomy 13, Trisomy 18, Trisomy 21, monosomy X (Turner syndrome); Structural abnormalities: (Deletions, duplications, translocations, and ring chromosomes and others.) 5)Congenital infections like TORCH (Toxoplasmosis, Rubella, Cytomegalovirus, Herpes simplex, Syphilis), as well as congenital HIV, Zika virus infection, parvovirus B19 infection, congenital tuberculosis, listeriosis and others 6)Infants with positive blood cultures with organisms that are frequently considered contaminants, including Bacillus species, Corynebacterium species and others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In hospital mortality and length of stay in hospital more than seven days for the treatment of late onset sepsisTimepoint: The study will be conducted over a span of one year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)nSOFA score trends over time 2)Individual components of the nSOFA score in neonates who survived & those who did not 3)nSOFA cut off value to predict mortality Timepoint: The study will be conducted over a span of one year | — |
Countries
India
Contacts
Public ContactDr S M Dhaded
Jawaharlal Nehru Medical College, KLE University
Outcome results
None listed