Comparison of two different forms of chlorhexidine solution for skin antisepsis in neonates
Not Applicable
Completed
- Registration Number
- CTRI/2019/06/019822
- Lead Sponsor
- All India Instiute of Medical Sciences AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 685
Inclusion Criteria
1) All inborn neonates from 26 0/7 - 42 6/7 weeks of gestation requiring NICU admission for at least 48 hrs
2) All extramural neonates from 26 0/7 - 42 6/7 weeks of gestation requiring admission in PICU/Pediatric surgery ICU/Pediatric HDU/Pediatric emergency irrespective of the duration of stay
Exclusion Criteria
1) Hydrops
2) Generalised skin disorder
3) Skin infection
4) Severe persistent pulmonary hypertension
5) Sick baby requiring high ventilator support as adjudged by the clinical team
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the proportion of negative post cleansing skin swabs after the skin antisepsis performed by 1% aqueous chlorhexidine gluconate v/s 2 % aqueous chlorhexidine gluconate in neonates 26 0/7-42 6/7 weeks of gestation in first 28 days of lifeTimepoint: post antisepsis skin swab will be taken after 2 minutes of chlorhexidine application
- Secondary Outcome Measures
Name Time Method Chlorhexidine level estimation in a subset of patientsTimepoint: at 6,12,24-48 hours after chlorhexidine application;To compare local skin reaction to chlorhexidine gluconate applicationTimepoint: At 0,6,12,24 hours after chlorhexidine application