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

NCT ID: NCT00947518

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-02-28

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.

Conditions

Neonatal Sepsis; Low Birth Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: DRUG

Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)

Saline skin cleansing

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Cleansing the skin (except the face)with baby wipes containing normal saline

No skin cleansing

No skin application

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Chlorhexidine

Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)

Intervention Type: DRUG

Normal saline

Cleansing the skin (except the face)with baby wipes containing normal saline

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 3 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Department of Pediatrics, AIIMS, New Delhi

Principal Investigators

Mari J Sankar, MD DM

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

Vinod K Paul, MD PhD

Role: STUDY_CHAIR

Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

Ashok K Deorari, MD MNAMS

Role: STUDY_CHAIR

Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

Gary L Darmstadt, MD MS

Role: STUDY_CHAIR

Department of International Health, Bloomberg School of Public Health, Johns Hopkins University

Other Identifiers

10/2004

Identifier Type: -

Identifier Source: org_study_id