Health Condition 1: P369- Bacterial sepsis of newborn, unspecified
Conditions
Interventions
None listed
Sponsors
AIIMS Raipur
Eligibility
Inclusion criteria
Inclusion criteria: ï?ª All Neonates admitted in Neonatal unit with clinical suspicion of sepsis for whom either workup for sepsis or blood culture will be sent before initiation of antibiotics. ï?ª Diagnosis of sepsis would be based on presence of clinical findings (one or more than one clinical finding) which would include the following 1. Respiratory compromise: respiratory rate >60 breaths per minute, or cessation of respiration for >=20 seconds, occurring at a rate of >=2 times per hour, or pulse oxymeter readings of 2. Cardiovascular compromise: heart rate more than 180/min with other physiological causes ruled out, pallor,or hypotension. 3. Metabolic changes: hypothermia (rectal temperature temperature of >38ï?°C, feeding intolerance (increased gastric residuals >50% of milk volume in >=2 feedings within 24 hours), glucose instability (blood glucose level 125 mg/dL), or metabolic acidosis (pH 4. Neurologic changes: lethargy or decreased activity ï?ª These clinical criteria is not all inclusive. All other condition leading to clinical suspicion of sepsis will be included.
Exclusion criteria
Exclusion criteria: Neonates who had recently undergone surgical interventions. ï?· Patients who had confirmed intrauterine infection (toxoplasmosis, rubella, cytomegalovirus, syphilis, and herpes). ï?· Babies having major malformations and inborn error of metabolism (IEM). ï?· Patients for whom consent cannot be taken from the parents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i.Early diagnosis of Neonatal sepsis. ii. To differentiate between Gram positive and Gram negative Neonatal sepsis and plan for appropriate empirical therapy. Timepoint: 18months | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Establishment of presepsin value as a cut-off point for diagnosing, grading, and differentiating culture positive and clinically confirmed sepsis at 18 months ii. The prevalence of Neonatal sepsis. iii. The commonest risk factors associated with early and late neonatal sepsis. iv. Antibiotic susceptibility of the causative organism of Neonatal sepsis. Timepoint: 15 months | — |
Countries
India
Contacts
Public ContactSIBANI BEHERA
AIIMS,RAIPUR
Outcome results
None listed