Role of zinc supplementation in newborns with bloodstream infectio
Phase 3
- Conditions
- Health Condition 1: null- Neonatal sepsis
- Registration Number
- CTRI/2014/08/004866
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
1. Gestational age >= 32weeks
2. Age < 28 days
3. Babies on enteral feeds.
4. Clinically diagnosed sepsis with at least two screening tests positive such as mESR, CRP and band cell count or positive blood culture.
Exclusion Criteria
1. Surgical conditions and major congenital malformations.
2. Apgar score < 6 at 5 min
3. Neonates who are already on treatment for sepsis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Decrease in mortality <br/ ><br>2. Decrease in serum calprotectin level <br/ ><br>3. Reduced adverse effects of acute inflammatory response <br/ ><br>Timepoint: 10 days
- Secondary Outcome Measures
Name Time Method 1. Associated complications (DIC, shock) <br/ ><br>2. Duration of hospital stay <br/ ><br>3. Requirement of antibiotics <br/ ><br>Timepoint: 10 days