Low Birth Weight, Neonatal Sepsis
Conditions
Keywords
chlorhexidine, preterm, newborn, skin condition, temperature, skin flora
Brief summary
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
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.
Interventions
DRUGChlorhexidine
Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
DRUGNormal saline
Cleansing the skin (except the face)with baby wipes containing normal saline
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 3 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Clinical and Culture Positive Sepsis | 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 |
Participant flow
Recruitment details
from August 2005 to February 2006 at the tertiary level neonatal intensive care unit of All India Institute of Medical Sciences, New Delhi
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Chlorhexidine Skin Cleansing Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate) | 20 |
| Saline Skin Cleansing Wiping the skin (except the face) using baby wipes containing normal saline | 20 |
| No Skin Cleansing No skin application | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Chlorhexidine Skin Cleansing | Saline Skin Cleansing | No Skin Cleansing | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Gestation (weeks) | 33 weeks | 33 weeks | 32.5 weeks | 33 weeks |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 11 Participants | 29 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 9 Participants | 31 Participants |
Outcome results
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)
Time frame: At 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chlorhexidine Skin Cleansing | Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al | 1 score on a scale |
| Saline Skin Cleansing | Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al | 1 score on a scale |
| No Skin Cleansing | Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al | 1 score on a scale |
p-value: 0.99Kruskal-Wallis
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
Time frame: 24 hours after intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chlorhexidine Skin Cleansing | Number of Participants With Positive Skin Culture at Axilla | 4 participants |
| Saline Skin Cleansing | Number of Participants With Positive Skin Culture at Axilla | 10 participants |
| No Skin Cleansing | Number of Participants With Positive Skin Culture at Axilla | 11 participants |
p-value: 0.06Chi-squared
Primary
Skin Temperature at 30 Min After Intervention
Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes
Time frame: at 30 min after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorhexidine Skin Cleansing | Skin Temperature at 30 Min After Intervention | 36.6 Degree Celsius | Standard Deviation 0.2 |
| Saline Skin Cleansing | Skin Temperature at 30 Min After Intervention | 36.6 Degree Celsius | Standard Deviation 0.12 |
| No Skin Cleansing | Skin Temperature at 30 Min After Intervention | 36.7 Degree Celsius | Standard Deviation 0.24 |
p-value: 0.46ANOVA
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
Time frame: First week of life
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chlorhexidine Skin Cleansing | Incidence of Clinical and Culture Positive Sepsis | Culture-positive sepsis | 1 Participants |
| Chlorhexidine Skin Cleansing | Incidence of Clinical and Culture Positive Sepsis | Clinical sepsis | 2 Participants |
| Saline Skin Cleansing | Incidence of Clinical and Culture Positive Sepsis | Culture-positive sepsis | 2 Participants |
| Saline Skin Cleansing | Incidence of Clinical and Culture Positive Sepsis | Clinical sepsis | 3 Participants |
| No Skin Cleansing | Incidence of Clinical and Culture Positive Sepsis | Culture-positive sepsis | 2 Participants |
| No Skin Cleansing | Incidence of Clinical and Culture Positive Sepsis | Clinical sepsis | 1 Participants |
p-value: <0.05Chi-squared