A study to check if C-Reactive Protein is needed before stopping antibiotics in newborn babies suspected to have bacterial infection whose blood cultures are negative
- Conditions
- Health Condition 1: R688- Other general symptoms and signs
- Registration Number
- CTRI/2020/05/025440
- Lead Sponsor
- CMC hospital Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1 Symptoms criteria
a Apnea
b Hyperthermia
c Respiratory distress
d Poor feeding
e Lethargy
f Irritability
g Hypothermia
h Hypotension
i Poor perfusion
j vomiting
k Feed intolerance
l Diarrhea
m Seizures
n Cyanosis
2 Laboratory criteria
a Have a total WBC count more than 5000 per cubic millimeter
b Have an Absolute Neutrophil Count more than 1500 per cubic millimeter
3 Baby becomes asymptomatic and are clinically well within 24 hours of suspicion of sepsis with following criteria
a Normal activity
b Stable temperature
c Stable hemodynamic status with no need for inotropes
d No respiratory support needed like supplementary oxygen CPAP ventilation
1 They have received antibiotics in the past 15 days
2 They have had surgery in the past 7 days
3 Total WBC count less than 5000 per cubic millimeter
4 Have an Absolute Neutrophil Count less than 1500 per cubic millimeter
5 Abnormal activity beyond 24 hours of suspicion of sepsis
6 Unstable temperature beyond 24 hours of suspicion of sepsis
7 Unstable hemodynamic status requiring inotropes
8 Respiratory support needed like supplementary oxygen CPAP ventilation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method