A study to see 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: P369- Bacterial sepsis of newborn, unspecifiedHealth Condition 2: null- Suspected Neonatal sepsis where blood culture is negative
- Registration Number
- CTRI/2016/06/007056
- Lead Sponsor
- Christian Medical College Hospital Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 220
Newborn babies who have any of the following symptoms of sepsis will have a blood count, blood culture done and started on appropriate antibiotics if the treating clinician feels that it is consistent with a diagnosis of suspected sepsis. The symptoms of sepsis are: Apnea, Hyperthermia, Respiratory distress, Poor feeding, Lethargy, Irritability, Hypothermia, Hypotension, Poor perfusion, vomiting, Feed intolerance, Diarrhea, Seizures, Cyanosis.
They will be included in the study if they fulfill the following criteria:
i.Become asymptomatic and are clinically well. within 24 hours of suspicion of sepsis. Babies are deemed to be clinically well if they satisfy the following clinically criteria:
1.Normal activity
2.Stable temperature
3.Stable hemodynamic status with no need for inotropes
4.No respiratory support needed (supplementary oxygen, CPAP, ventilation)
ii.Have a total WBC count > 5000/cu.mm
iii.Have an Absolute Neutrophil Count >1500/cu.mm
iv.Have an immature: total neutrophil ratio of <0.2
v.Have a sterile blood culture 48 hours after inoculation
a)They have received antibiotics in the past 15 days
b)They have had surgery in the past 7 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method