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Completed

NCT Number: NCT00947518

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine

Drug

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

normal saline

Drug

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

Primary outcomes

  1. Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al

    Time frame: At 24 hours

    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)

  2. Skin Temperature at 30 Min After Intervention

    Time frame: at 30 min after intervention

    Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes

  3. Number of Participants With Positive Skin Culture at Axilla

    Time frame: 24 hours after intervention

    Occurrence of any bacterial flora irrespective of the colony count in the skin swabs from axilla at 24 hrs after intervention

Secondary outcomes

  1. Incidence of Clinical and Culture Positive Sepsis

    Time frame: First week of life

    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

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jul 28, 2009
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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