Choice of antibiotic in babies at risk of sepsis but without symptoms
Not Applicable
Completed
- Conditions
- Health Condition 1: P369- Bacterial sepsis of newborn, unspecifiedHealth Condition 2: null- Neonates of gestational age more than or equal to 34 weeks with birth weight above 1800 g who are asymptomatic at birth and can be fed orally.
- Registration Number
- CTRI/2017/04/008335
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
include all the following:
1. Consecutively delivered neonates of gestational age 34 weeks and beyond
2. with maternal risk factors for sepsis
2. who are otherwise asymptomatic at birth
3. accepting cup feeds and/or breastfeeds
Maternal risk factors for sepsis are defined as presence of one or more of the following:
o Leaking per vagina >18 hours
o Foul smelling liquor
o Maternal intrapartum fever >37.5°C in the period from onset of labor to 1 hour after delivery.
Exclusion criteria:
1. Perinatal asphyxia
2. Respiratory distress
3. Major congenital malformations
Exclusion Criteria
1. Perinatal asphyxia
2. Meconium aspiration syndrome
3. Congenital infections (TORCH, syphilis and HIV)
4. Surgical conditions and major congenital anomalies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of clinical signs of sepsis not explained otherwise with or without a positive blood cultureTimepoint: 72 hours of age
- Secondary Outcome Measures
Name Time Method 1. Development of sepsis with or without a positive blood culture by 7 days of life <br/ ><br>2. Feasibility <br/ ><br>3. Adherence to study protocol <br/ ><br>4. Adverse effects of drug therapy <br/ ><br>5. Cost-effectiveness <br/ ><br>Timepoint: 72 hours and 7 days of life