Neonatal SepsisPhase 2/3CAPSNCT01723501
Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing <1500 g at Birth
A Phase 2/3 study testing 0.25% chlorhexidine and sterile water in people with Neonatal Sepsis and Neonatal Mortality Rate, run by All India Institute of Medical Sciences at 3 sites in India.
Trial summary
Purpose of this study is determine if skin application of chlorhexidine at birth would reduce infection in infants weighing <1500 g at birth. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Neonatal Sepsis, Neonatal Mortality Rate
- What is being tested?
- 0.25% chlorhexidine and sterile water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesIndia
- Study dates
- Nov 2012to not given
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight less than 1500 g
Who cannot join
- Birth weight <750 g
- Major congenital malformations
- Total duration of positive pressure ventilation (PPV) > 3 mins OR chest compressions
- Shock- requiring inotropes >10 mic/kg/min
Trial locations and contacts
3 sites in 1 country.
India3 sites
Maulana Azad Medical College
New Delhi, National Capital Territory of Delhi, 110002
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Vardhman Medical College and Safdarjung Hospital
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Whole Body Cleansing With 0.25% Chlorhexidine at Birth for Prevention of Sepsis in Infants <1500 g: a Multi-center, Blinded, Randomized Trial
Purpose of this study is determine if skin application of chlorhexidine at birth would reduce infection in infants weighing <1500 g at birth.
Read the detailed description
Background
Infants weighing <1500 g at birth infants are more prone to acquire infections, often through their immature skin which serve as a portal of entry for invasive pathogens. Skin application of antiseptics such as chlorhexidine may reduce infections in these infants. However, there is a paucity of data on the safety and efficacy of such intervention in these infants.
Hypothesis:
Among hospitalized very low birth weight (VLBW; <1500 g) neonates, single whole body skin cleansing with 0.25% chlorhexidine within 6 hours after birth would reduce the incidence of sepsis in the first seven days of life from 25% to 17.5% (relative reduction of 30%) when compared to skin cleansing with sterile water
Objectives:
Primary- To evaluate the effect of whole body skin cleansing with 0.25% chlorhexidine (single application, at birth) on the incidence of sepsis (culture positive or culture negative) compared to sterile water cleansing in the first week of life in VLBW infants
Secondary- to compare following outcomes in this experiment:
- Culture-confirmed sepsis within the first week of life
- Need for repeat hospital admissions within first 28 days of life
- Mortality within first 28 days of life
- Cold stress/hypothermia at 0, 5, 15 and 30 minutes of intervention
- Skin condition at 24 h of life
- Colonization rates (subset)
- Serum levels of chlorhexidine (subset)
Methods:
Eligible infants would be randomized within 6 hours of birth to either whole body skin cleansing with chlorhexidine (specially prepared wipes releasing 0.25% chlorhexidine), or sterile water (placebo). The research staff would collect the baseline data, record the axillary temperature and assess the skin condition using the Newborn Skin Condition Scoring (NSCS)score. The research team would follow the infants for development of sepsis and other outcomes. The infants would be subjected to detailed sepsis work up on clinical suspicion of sepsis, until 28 days of life.
Sepsis would be defined based on combination of clinical course, indirect markers, bacterial culture results and antibiotic treatment status.
- Conditions
- Neonatal Sepsis, Neonatal Mortality Rate
- Being tested
- 0.25% chlorhexidine, sterile water
- Keywords
- chlorhexidine, sepsis, neonatal, whole-body skin cleansing
- Medical subject headings
- Neonatal Sepsis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% chlorhexidineDrug
Also called Chx
0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application
sterile waterDrug
Sterile water wipes (placebo)
| Study group | Role | What they receive |
|---|---|---|
| sterile water | Placebo comparator | sterile water wipes Receives: Drug: sterile water |
| 0.25% chlorhexidine | Experimental | 0.44% chlorhexidine digluconate wipes which will release 0.25% free chlorhexidine Receives: Drug: 0.25% chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis within first 7 days of life
Sepsis would be defined on the basis of clinical course, lab parameters including culture results and antibiotic treatment given.
Measured: First 7 days of life
Secondary outcomes (5)
Readmissions & mortality rates within neonatal period
The re-admissions \& mortality rates within neonatal period in these infants will be prospectively recorded during hospital admission as well as follow up. The follow up includes telephonic contact as well as home visits and verbal autopsy in cases of deaths at home.
Measured: 28 days
Body temperature at 0, 5, 15, 30 minutes after application
Axillary temperature would be monitored with thermometer at above time points for full three minutes.
Measured: 30 minutes
Skin condition
Newborn Skin Condition Score (NSCS)will be used to assess the skin condition.
Measured: 24 ±6 hours
Skin colonization rates
In a sub-group of infants, skin swabs will be collected at baseline and 24 ±6 hours and sent to microbiology lab; colonization rates would be determined by semi-quantitative methods.
Measured: 24 ±6 hours
Chlorhexidine percutaneous absorption
Serum chlorhexidine levels will be assayed in a sub-set to assess the extent of percutaneous absorption. 5ml of blood will be stored at -80 deg. C till transport to the lab. Samples will be processed in batches as per standard protocol to determine the levels.
Measured: 48 ±6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startNov 2012
Why it stopped: The study was not started and prematurely closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Maulana Azad Medical College, Vardhman Mahavir Medical College And Safdarjung Hospital
- Responsible party
- Principal investigator, Dr Vinod K Paul, All India Institute of Medical Sciences
- Investigators
- Vinod K Paul, MD, PhD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723501
- Sponsor's protocol ID
- NHKC-Chx2012
- Acronym
- CAPS
- Status last verified
- Jul 2016
- First submitted
- 6 Nov 2012
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Cleansing With 0.25% Chlorhexidine at Birth for Prevention of Sepsis in Infants <1500 g: a Multi-center, Blinded, Randomized Trial
- ClinicalTrials.gov ID
- NCT01723501
- Acronym / sponsor ID
- CAPS / NHKC-Chx2012
- Conditions
- Neonatal Sepsis, Neonatal Mortality Rate
- Keywords
- chlorhexidine, sepsis, neonatal, whole-body skin cleansing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not started and prematurely closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- Maulana Azad Medical College, Vardhman Mahavir Medical College And Safdarjung Hospital
- Study start
- Nov 2012
- First posted
- 8 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of this study is determine if skin application of chlorhexidine at birth would reduce infection in infants weighing <1500 g at birth.
Detailed description
Background
Infants weighing <1500 g at birth infants are more prone to acquire infections, often through their immature skin which serve as a portal of entry for invasive pathogens. Skin application of antiseptics such as chlorhexidine may reduce infections in these infants. However, there is a paucity of data on the safety and efficacy of such intervention in these infants.
Hypothesis:
Among hospitalized very low birth weight (VLBW; <1500 g) neonates, single whole body skin cleansing with 0.25% chlorhexidine within 6 hours after birth would reduce the incidence of sepsis in the first seven days of life from 25% to 17.5% (relative reduction of 30%) when compared to skin cleansing with sterile water
Objectives:
Primary- To evaluate the effect of whole body skin cleansing with 0.25% chlorhexidine (single application, at birth) on the incidence of sepsis (culture positive or culture negative) compared to sterile water cleansing in the first week of life in VLBW infants
Secondary- to compare following outcomes in this experiment:
- Culture-confirmed sepsis within the first week of life
- Need for repeat hospital admissions within first 28 days of life
- Mortality within first 28 days of life
- Cold stress/hypothermia at 0, 5, 15 and 30 minutes of intervention
- Skin condition at 24 h of life
- Colonization rates (subset)
- Serum levels of chlorhexidine (subset)
Methods:
Eligible infants would be randomized within 6 hours of birth to either whole body skin cleansing with chlorhexidine (specially prepared wipes releasing 0.25% chlorhexidine), or sterile water (placebo). The research staff would collect the baseline data, record the axillary temperature and assess the skin condition using the Newborn Skin Condition Scoring (NSCS)score. The research team would follow the infants for development of sepsis and other outcomes. The infants would be subjected to detailed sepsis work up on clinical suspicion of sepsis, until 28 days of life.
Sepsis would be defined based on combination of clinical course, indirect markers, bacterial culture results and antibiotic treatment status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sterile water | Placebo comparator | Drug: sterile watersterile water wipes |
| 0.25% chlorhexidine | Experimental | Drug: 0.25% chlorhexidine0.44% chlorhexidine digluconate wipes which will release 0.25% free chlorhexidine |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Birth weight less than 1500 g
Key exclusion criteria (4 listed)
- Birth weight <750 g
- Major congenital malformations
- Total duration of positive pressure ventilation (PPV) > 3 mins OR chest compressions
- Shock- requiring inotropes >10 mic/kg/min
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 |
|---|---|---|
| 0.25% chlorhexidineAlso: Chx0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application | Drug | 0.25% chlorhexidine |
| sterile waterSterile water wipes (placebo) | Drug | sterile water |
Primary outcome
Sepsis within first 7 days of life
Time frame: First 7 days of life
Sepsis would be defined on the basis of clinical course, lab parameters including culture results and antibiotic treatment given.
5 secondary outcomes
Readmissions & mortality rates within neonatal period
Time frame: 28 days
Body temperature at 0, 5, 15, 30 minutes after application
Time frame: 30 minutes
Skin condition
Time frame: 24 ±6 hours
Skin colonization rates
Time frame: 24 ±6 hours
Chlorhexidine percutaneous absorption
Time frame: 48 ±6 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
- Related InfoLink provided by the sponsor.
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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.
Vinod K Paul, MD, PhD principal investigator
All India Institute of Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 0.25% chlorhexidine and sterile water in people with Neonatal Sepsis and Neonatal Mortality Rate, run by All India Institute of Medical Sciences at 3 sites in India.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Sepsis within first 7 days of life (time frame: First 7 days of life). 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 18 Jul 2016.