To determine effectiveness and safety of octenidine wipes in babies admitted in the neonatal intensive care unit
Phase 3
Completed
- Conditions
- Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue
- Registration Number
- CTRI/2020/11/028918
- Lead Sponsor
- Bharati Hospital and research centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Neonates admitted in level 3 NICU, Bharati hospital and research centre (inborn as well as outborn),
a) Babies born at more than 28 weeksââ?¬• gestation and postnatal age of at least 24 hours OR
b) Babies admitted to NICU who are more than 4 weeks old
Exclusion Criteria
Neonates with
a) congenital skin anomalies
b) extremely sick newborns, not allowing routine bathing care.
Extremely sick being defined as those newborns not mandating any kind of external movement for eg. those on high frequency oscillatory ventilation or those with pulmonary hypertension and requiring multiple inotropes
c) born less than 28 weeksââ?¬• gestation and less than 4 weeks of chronological age
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility and acceptability of Octenidine wipes as a routine cleansing measure for babies admitted to NICU <br/ ><br>Arm and groin Gram Negative colonization, measured in log CFU/ml, at baseline and 48 hours after the first octenidine wipe use.Timepoint: At baseline meaning at 72 hours of life and again after 48 hours after usage of first wipe
- Secondary Outcome Measures
Name Time Method Arm and groin Gram Positive bacterial colonization, measured in log CFU/ml, at baseline and 48 hours after the first octenidine wipe use. <br/ ><br>Timepoint: 0 and 48 hours