Presepsin as a sepsis biomarker in Neonatal Sepsis
- Conditions
- Health Condition 1: P369- Bacterial sepsis of newborn, unspecified
- Registration Number
- CTRI/2021/12/038553
- Lead Sponsor
- AIIMS Raipur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <=90%
2. Cardiovascular compromise: heart rate <100 beats per minute or
more than 180/min with other physiological causes ruled out,
pallor,or hypotension.
3. Metabolic changes: hypothermia (rectal temperature <36°C),a body
temperature of >38ï?°C, feeding intolerance (increased gastric
residuals >50% of milk volume in >=2 feedings within 24 hours),
glucose instability (blood glucose level <45 or >125 mg/dL), or
metabolic acidosis (pH < 7.25); or
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method