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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neonatal Sepsis, Low Birth Weight

Intervention / Treatment
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* Drug: Chlorhexidine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 3 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine skin cleansing<br>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<br>* Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)<br>|
| Placebo Comparator: Saline skin cleansing<br>Wiping the skin (except the face) once immediately after birth using baby wipes containing normal saline | Drug: Normal saline<br>* Cleansing the skin (except the face)with baby wipes containing normal saline<br>|
| No Intervention: No skin cleansing<br>No skin application | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chlorhexidine, preterm, newborn, skin condition, temperature, skin flora