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

All India Institute Of Medical Science (AIIMS)

Status: Completed

Conditions: Neonatal Sepsis; Low Birth Weight

Treatments: Drug: Normal saline; Drug: Chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00947518

10/2004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 3 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Chlorhexidine skin cleansing

Experimental group

Description:

Wiping the skin (except the face) once immediately after birth using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)

Treatment:

Drug: Chlorhexidine

Saline skin cleansing

Placebo Comparator group

Description:

Wiping the skin (except the face) once immediately after birth using baby wipes containing normal saline

Treatment:

Drug: Normal saline

No skin cleansing

No Intervention group

Description:

No skin application