N/A N=60 Randomized Triple-blind Prevention

Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants

Neonatal Sepsis · Low Birth Weight

Bottom Line

View on ClinicalTrials.gov: NCT00947518 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Jul 2009

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Chlorhexidine (Drug); Normal saline (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: All India Institute of Medical Sciences
Primary completion: Feb 2006

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

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.

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

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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.