Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants
Does Skin Cleansing With Chlorhexidine Affect Skin Condition, Temperature and Colonization in Hospitalized Preterm Low Birth Weight Infants?: A Randomized Clinical Trial
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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)
|
Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
|
|
위약 비교기: Saline skin cleansing
Wiping the skin (except the face) once immediately after birth using baby wipes containing normal saline
|
Cleansing the skin (except the face)with baby wipes containing normal saline
|
|
간섭 없음: No skin cleansing
No skin application
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al
기간: 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)
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At 24 hours
|
|
Skin Temperature at 30 Min After Intervention
기간: at 30 min after intervention
|
Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes
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at 30 min after intervention
|
|
Number of Participants With Positive Skin Culture at Axilla
기간: 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
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24 hours after intervention
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Clinical and Culture Positive Sepsis
기간: 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
|
First week of life
|
공동 작업자 및 조사자
수사관
- 연구 의자: Vinod K Paul, MD PhD, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- 수석 연구원: Mari J Sankar, MD DM, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- 연구 의자: Ashok K Deorari, MD MNAMS, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- 연구 의자: Gary L Darmstadt, MD MS, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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