Neonatal SepsisNCT00947518
Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants
A study testing Chlorhexidine and Normal saline in people with Neonatal Sepsis and Low Birth Weight, run by All India Institute of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 3 hours
- Conditions the study is for
- Neonatal Sepsis, Low Birth Weight
- What is being tested?
- Chlorhexidine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Feb 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 3 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants of 28 to 36 weeks' gestation
- Birth weights between 1001 and 2000 g
Who cannot join
- 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
About this study
Official title: Does Skin Cleansing With Chlorhexidine Affect Skin Condition, Temperature and Colonization in Hospitalized Preterm Low Birth Weight Infants?: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Neonatal Sepsis, Low Birth Weight
- Being tested
- Chlorhexidine, Normal saline
- Keywords
- chlorhexidine, preterm, newborn, skin condition, temperature, skin flora
- Medical subject headings
- Neonatal Sepsis, Premature Birth, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
Normal salineDrug
Cleansing the skin (except the face)with baby wipes containing normal saline
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Chlorhexidine |
| Saline skin cleansing | Placebo comparator | Wiping the skin (except the face) once immediately after birth using baby wipes containing normal saline Receives: Drug: Normal saline |
| No skin cleansing | No intervention | No skin application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At 24 hours
Skin Temperature at 30 Min After Intervention
Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes
Measured: 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
Measured: 24 hours after intervention
Secondary outcomes (1)
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
Measured: First week of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startAug 2005
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mari J Sankar, MD DM, Principal investigator, Department of Pediatrics, All India Institute of Medical Sciences, New DelhiVinod K Paul, MD PhD, Study chair, Department of Pediatrics, All India Institute of Medical Sciences, New DelhiAshok K Deorari, MD MNAMS, Study chair, Department of Pediatrics, All India Institute of Medical Sciences, New DelhiGary L Darmstadt, MD MS, Study chair, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947518
- Sponsor's protocol ID
- 10/2004
- Status last verified
- Jun 2009
- First submitted
- 20 Apr 2009
- Last updated
- 25 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Skin Cleansing With Chlorhexidine Affect Skin Condition, Temperature and Colonization in Hospitalized Preterm Low Birth Weight Infants?: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00947518
- Acronym / sponsor ID
- 10/2004
- Conditions
- Neonatal Sepsis, Low Birth Weight
- Keywords
- chlorhexidine, preterm, newborn, skin condition, temperature, skin flora
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Posted 28 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine skin cleansing | Experimental | Drug: ChlorhexidineWiping 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 | Drug: Normal salineWiping the skin (except the face) once immediately after birth using baby wipes containing normal saline |
| No skin cleansing | No intervention | –No skin application |
Who may qualify
- Ages
- 1 hour to 3 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants of 28 to 36 weeks' gestation
- Birth weights between 1001 and 2000 g
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChlorhexidineBaby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate) | Drug | Chlorhexidine skin cleansing |
| Normal salineCleansing the skin (except the face)with baby wipes containing normal saline | Drug | Saline skin cleansing |
Primary outcome
Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al
Time frame: 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
Time frame: 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
Time frame: 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
1 secondary outcome
Incidence of Clinical and Culture Positive Sepsis
Time frame: First week of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mari J Sankar, MD DM principal investigator
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Vinod K Paul, MD PhD study chair
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Ashok K Deorari, MD MNAMS study chair
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine and Normal saline in people with Neonatal Sepsis and Low Birth Weight, run by All India Institute of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al (time frame: At 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.