Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Does Skin Cleansing With Chlorhexidine Affect Skin Condition, Temperature and Colonization in Hospitalized Preterm Low Birth Weight Infants?: A Randomized Clinical Trial|
- Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al [ Time Frame: At 24 hours ] [ Designated as safety issue: Yes ]
- Skin Temperature at 30 Min After Intervention [ Time Frame: at 30 min after intervention ] [ Designated as safety issue: Yes ]
- Number of Participants With Positive Skin Culture at Axilla [ Time Frame: 24 hours after intervention ] [ Designated as safety issue: No ]
- Incidence of Clinical and Culture Positive Sepsis [ Time Frame: First week of life. ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||February 2006|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
Experimental: Chlorhexidine skin cleansing
Wiping the skin (except the face) once immediately after birth using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
Placebo Comparator: Saline skin cleansing
Wiping the skin (except the face) once immediately after birth using baby wipes containing normal saline
Drug: Normal saline
Cleansing the skin (except the face)with baby wipes containing normal saline
No Intervention: No skin cleansing
No skin application
Infections are the leading cause of death in neonates admitted to hospital - studies from developing countries suggest that about 25-71% of deaths occurring in neonatal intensive care units are secondary to infections.Such high infection-related mortality mandates an urgent implementation of simple and effective measures to prevent the occurrence of infections in these units.
The majority of neonatal infections occur in the first two weeks of life, when the epidermal barrier is immature and functionally compromised. Topical application of antiseptics until the skin matures could theoretically prevent skin colonization and reduce the incidence of systemic infections in neonates. Chlorhexidine, a broad-spectrum antiseptic used frequently for umbilical cord care in neonates, is now being evaluated for topical application to the skin. Hospital-based studies, involving predominantly term infants, have shown reductions in skin flora8 and a reduction in the incidence of sepsis following topical chlorhexidine application. In a community-based study in Nepal, a single skin cleansing with 0.25% chlorhexidine resulted in reduction in mortality among low birth weight infants; though the mechanism of the impact could not be determined, it was presumably due to increased susceptibility to transcutaneous sepsis in the low birth weight group.
Since the risk of infection in neonates is inversely related to their gestation, it is essential to evaluate the effect and the mechanism of such intervention in preterm neonates. These infants are, however, more prone to develop skin reactions following use of topical antiseptics. Preterm infants are also more prone to develop hypothermia following bathing/cleansing with antiseptic solution(s).
Since few studies have evaluated the effects of topical application of chlorhexidine in preterm infants admitted in a health care facility, we conducted the present study to examine if single skin cleansing with 0.25% chlorhexidine immediately after birth affects skin condition, temperature, and colonization in hospitalized preterm low birth weight infants.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947518
|Principal Investigator:||Mari J Sankar, MD DM||Department of Pediatrics, All India Institute of Medical Sciences, New Delhi|
|Study Chair:||Vinod K Paul, MD PhD||Department of Pediatrics, All India Institute of Medical Sciences, New Delhi|
|Study Chair:||Ashok K Deorari, MD MNAMS||Department of Pediatrics, All India Institute of Medical Sciences, New Delhi|
|Study Chair:||Gary L Darmstadt, MD MS||Department of International Health, Bloomberg School of Public Health, Johns Hopkins University|