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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Saline skin cleansing | Placebo Comparator | Wiping the skin (except the face) once immediately after birth using baby wipes containing normal saline |
|
| No skin cleansing | No Intervention | No skin application |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Drug | Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mari J Sankar, MD DM | Department of Pediatrics, All India Institute of Medical Sciences, New Delhi | Principal Investigator |
| 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 | Study Chair |
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Infants with one minute Apgar score <4, hemodynamic instability, congenital malformations, generalized skin disorder and who needed respiratory support (continuous positive airway pressure and/or intermittent mandatory ventilation) were excluded
from August 2005 to February 2006 at the tertiary level neonatal intensive care unit of All India Institute of Medical Sciences, New Delhi
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| ID | Title | Description |
|---|---|---|
| FG000 | Chlorhexidine Skin Cleansing | Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate) |
| FG001 | Saline Skin Cleansing | Wiping the skin (except the face) using baby wipes containing normal saline |
| FG002 | No Skin Cleansing | No skin application |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chlorhexidine Skin Cleansing | Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate) |
| BG001 | Saline Skin Cleansing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Median | Full Range | score on a scale | At 24 hours |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mari Jeeva Sankar | Department of Pediatrics, All India Institute of Medical Sciences, New Delhi | +91-11-26594372 | jeevasankar@gmail.com |
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| D047928 | Premature Birth |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000077324 |
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| Normal saline | Drug | Cleansing the skin (except the face)with baby wipes containing normal saline |
|
Wiping the skin (except the face) using baby wipes containing normal saline
| BG002 | No Skin Cleansing | No skin application |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Gestation (weeks) | Estimated gestational age in completed weeks | Median | Full Range | weeks |
|
| OG002 | No Skin Cleansing | No skin application |
|
|
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| Primary | Skin Temperature at 30 Min After Intervention | Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes | Posted | Mean | Standard Deviation | Degree Celsius | at 30 min after intervention |
|
|
|
|
| Primary | 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 | Posted | Number | participants | 24 hours after intervention |
|
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | First week of life |
|
|
|
|
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| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Title | Measurements |
|---|---|
|