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

Neonatal Sepsis Clinical Trial

Official title:

Does Skin Cleansing With Chlorhexidine Affect Skin Condition, Temperature and Colonization in Hospitalized Preterm Low Birth Weight Infants?: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947518
• Other study ID #: 10/2004
• Status: Completed
• Phase: N/A
• Start date: August 2005
• Est. completion date: February 2006

Study information

• Verified date: June 2009
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Hours

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Low Birth Weight
• Neonatal Sepsis

Intervention

Drug:
• Chlorhexidine
Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
• Normal saline
Cleansing the skin (except the face)with baby wipes containing normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al	The skin condition grading scale assesses the condition of the skin on the abdomen and dorsum of the hands/feet based on drying, erythema, crusting, oozing, etc. on a continuous scale from 1 (normal) to 9 (vesicles or pustules)	At 24 hours
Primary	Skin Temperature at 30 Min After Intervention	Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes	at 30 min after intervention
Primary	Number of Participants With Positive Skin Culture at Axilla	Occurrence of any bacterial flora irrespective of the colony count in the skin swabs from axilla at 24 hrs after intervention	24 hours after intervention
Secondary	Incidence of Clinical and Culture Positive Sepsis	Infants with symptoms and/or signs suggestive of sepsis and a positive blood culture (with known pathogens and coagulase negative staphylococcus) were diagnosed to have culture positive sepsis; Those with negative cultures but with positive sepsis screen were classified as having clinical sepsis	First week of life