N/A
Completed N=60
Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants
Source: ClinicalTrials.gov NCT00947518 ↗Enrolled (actual)
60
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al — 1; 1; 1 score on a scale — p=0.99
Summary
The purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine affects skin condition, temperature, and bacterial colonization in stable preterm (28-36 weeks gestational age) low birth weight (1001-2000 g) infants admitted in a health facility.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al |
1; 1; 1 | 0.99 |
| PRIMARY Skin Temperature at 30 Min After Intervention |
36.6; 36.6; 36.7 | 0.46 |
| PRIMARY Number of Participants With Positive Skin Culture at Axilla |
4; 10; 11 | 0.06 |
| SECONDARY Incidence of Clinical and Culture Positive Sepsis |
1; 2; 2; 2; 3; 1 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Preterm infants of 28 to 36 weeks' gestation
- Birth weights between 1001 and 2000 g
Exclusion Criteria
- Infants with one minute Apgar score < 4
- Hemodynamic instability
- Congenital malformations
- Generalized skin disorder and
- Infants who need respiratory support (continuous positive airway pressure and/or intermittent mandatory ventilation) in the first 2-3 hours of life
Data sourced from ClinicalTrials.gov (NCT00947518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.