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临床试验/NCT00947518
NCT00947518已完成不适用

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

All India Institute of Medical Sciences, New Delhi0 个研究点目标入组 60 人开始时间: 2005年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Hour 至 3 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants of 28 to 36 weeks' gestation
  • Birth weights between 1001 and 2000 g

排除标准

  • 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

研究组 & 干预措施

Chlorhexidine skin cleansing

Experimental

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

干预措施: Chlorhexidine (Drug)

Saline skin cleansing

Placebo Comparator

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

干预措施: Normal saline (Drug)

结局指标

主要结局

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

时间窗: 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)

Skin Temperature at 30 Min After Intervention

时间窗: at 30 min after intervention

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

Number of Participants With Positive Skin Culture at Axilla

时间窗: 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

次要结局

  • Incidence of Clinical and Culture Positive Sepsis(First week of life)

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other

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