Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing less than 1500 g at Birth (CAPS)
Phase 3
- Conditions
- Health Condition 1: null- Neonatal sepsis
- Registration Number
- CTRI/2014/05/004599
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 1282
Inclusion Criteria
Intramural infants with birth weight less than 1500 g
Exclusion Criteria
Birth weight less than750 g; Major congenital malformations; Total duration of positive pressure ventilation (PPV) > 3 mins OR chest compressions; Shock- requiring inotropes >10 mic/kg/min
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sepsis within first 7 days of lifeTimepoint: Within first 7 days of life
- Secondary Outcome Measures
Name Time Method Body temperature at 0, 5, 15, 30 minutes after applicationTimepoint: 30 minutes;Chlorhexidine percutaneous absorptionTimepoint: 48 ±6 hours;Readmissions and mortality rates within neonatal periodTimepoint: 28 days;Skin colonization ratesTimepoint: 24 ±6 hours;Skin condition (as measured by NSCS)Timepoint: 24 ±6 hours