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

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00947518
First received: April 20, 2009
Last updated: July 27, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
Neonatal Sepsis
Low Birth Weight
Drug: Chlorhexidine
Drug: Normal saline

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Incidence of Clinical and Culture Positive Sepsis [ Time Frame: First week of life. ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: August 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: Chlorhexidine
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

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

Ages Eligible for Study:   up to 3 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947518

Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
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
  More Information

No publications provided

Responsible Party: M Jeeva Sankar, Department of Pediatrics, AIIMS, New Delhi
ClinicalTrials.gov Identifier: NCT00947518     History of Changes
Other Study ID Numbers: 10/2004
Study First Received: April 20, 2009
Results First Received: April 20, 2009
Last Updated: July 27, 2009
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
chlorhexidine
preterm
newborn
skin condition
temperature
skin flora

Additional relevant MeSH terms:
Birth Weight
Sepsis
Skin Diseases
Body Weight
Signs and Symptoms
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on July 22, 2014