Clinical trial NCT00947518: Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants
Official title: Does Skin Cleansing With Chlorhexidine Affect Skin Condition, Temperature and Colonization in Hospitalized Preterm Low Birth Weight Infants?: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Sepsis
Low Birth Weight
Keywords: chlorhexidine
preterm
newborn
skin condition
temperature
skin flora
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2009-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al
timeFrame: At 24 hours
measure: Skin Temperature at 30 Min After Intervention
timeFrame: at 30 min after intervention
measure: Number of Participants With Positive Skin Culture at Axilla
timeFrame: 24 hours after intervention
Secondary outcomes:
measure: Incidence of Clinical and Culture Positive Sepsis
timeFrame: First week of life
Other outcomes:
Locations:
Study officials:
affiliation: Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
name: Mari J Sankar, MD DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
name: Vinod K Paul, MD PhD
role: STUDY_CHAIR
affiliation: Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
name: Ashok K Deorari, MD MNAMS
role: STUDY_CHAIR
affiliation: Department of International Health, Bloomberg School of Public Health, Johns Hopkins University
name: Gary L Darmstadt, MD MS
role: STUDY_CHAIR
References: