OmphalitisPhase 3CHXNCT00434408
Impact of Umbilical Cord Cleansing With 4.0% Chlorhexidine on Neonatal Mortality
A Phase 3 study testing chx once, CHX x 7 days and dry cord care in people with Omphalitis and Infection, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
Trial summary
A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution Read more about this study
- Who is it for?
- Ages 1 minute to 7 days
- Conditions the study is for
- Omphalitis, Infection
- What is being tested?
- chx once, CHX x 7 days and dry cord care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28,797 participants
- Where
- 1 siteBangladesh
- Study dates
- May 2007to Nov 2010
- Phase
- Phase 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 1 minute to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- live-born infants delivered in one of three upazillas of Sylhet District (Zakiganj, Khanaighat, Beanibazar)
- married women of reproductive age within their individual target areas listed above
Who cannot join
- individuals outside of the target area in Sylhet(Zakiganj, Khanaighat, Beanibazar)
- infants not met at home by a project worker during the first seven days of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Umbilical Cord Cleansing With Chlorhexidine on Neonatal Mortality and Omphalitis in Rural Sylhet District of Bangladesh
A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution
Read the detailed description
Of the annual four million neonatal deaths, 99% occur in developing countries, and more than one-third globally can be attributed to infections. In areas with high-mortality rates, the proportion attributable to infections is as high as 50%. Many infections in infants can be prevented or treated with already existing measures, yet finding the best way to provide these measures in communities that are limited in resources need to be identified. Applying chlorhexidine to the umbilical cord of newborns may be a simple way to help reduce neonatal mortality and morbidity in the community at low cost.
A study by our group was recently completed in Nepal. It was a large community-based, factorial-designed trial in southern Nepal to: (1) assess the impact of newborn total body skin cleansing with 0.25% chlorhexidine on neonatal mortality and morbidity and (2) assess the impact of cleansing of the umbilical stump with 4% chlorhexidine on omphalitis and neonatal mortality.
The results of these studies have suggested that chlorhexidine antisepsis interventions may significantly reduce neonatal mortality and omphalitis. A single full body cleansing of the neonate with chlorhexidine as soon as possible after birth reduced mortality among low birth weight (LBW) infants by 28%. Repeated cleansing of the umbilical stump with chlorhexidine reduced the rate of severe cord infection by 75% and, if this treatment was begun within the first 24 hours following birth, reduced neonatal mortality by 34%.
In rural Bangladesh, over 90% of women deliver at home with only untrained local women or family members in attendance, and low birth weight babies are delivered approximately 30% of the time. The overall neonatal mortality rate exceeds 36 per 1000 live births and in order to reduce this burden, simple, cost-effective interventions that can be delivered at the community level are urgently needed. Given the potential impact of repeated chlorhexidine cleansing of the cord demonstrated in the Nepal trial, a replication study of this regimen and further investigations of more simple regimens are necessary. The number of treatments necessary to reduce neonatal mortality has important programmatic implications for who can deliver the intervention, and how it is packaged.
- Conditions
- Omphalitis, Infection
- Being tested
- chx once, CHX x 7 days, dry cord care
- Keywords
- omphalitis, neonates, umbilical cord, infection, infant mortality, neonate morbidity, chlorhexidine
- Medical subject headings
- Infections, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chx onceBehavioural
4.0% chlorhexidine cleansing of the cord applied once by a project worker visiting the newborn in the home as soon as possible after birth
CHX x 7 daysBehavioural
4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth
dry cord careBehavioural
Household members are instructed to apply nothing to the newborn's umbilical cord stump.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth Receives: Behavioral: CHX x 7 days |
| 2 | Experimental | 4.0% chlorhexidine cleansing of the cord applied once by a project worker visiting the newborn in the home as soon as possible after birth Receives: Behavioral: chx once |
| 3 | Active comparator | dry cord care Receives: Behavioral: dry cord care |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal mortality
Measured: 3 Month intervals
omphalitis among live born infants.
Measured: 3 Month intervals
Secondary outcomes (3)
newborn care practices
Measured: 3 Years
care seeking behaviors
Measured: 3 Years
morbidity measures, including sepsis and omphalitis
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for OmphalitisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 28,797 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Bangladesh, International Centre for Diarrhoeal Disease Research, Bangladesh, Save the Children, Shimantik
- Responsible party
- Sponsor
- Investigators
- Abdullah H Baqui, MBBS, DrPH, Principal investigator, Johns Hopkins Bloomberg School of Public HealthShams El Arifeen, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434408
- Sponsor's protocol ID
- IRB00000146
- Other IDs
- GHSA00030001900
- Acronym
- CHX
- Status last verified
- Jul 2007
- First submitted
- 9 Feb 2007
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Aggett PJ, Cooper LV, Ellis SH, McAinsh J. Percutaneous absorption of chlorhexidine in neonatal cord care. Arch Dis Child. 1981 Nov;56(11):878-80. doi: 10.1136/adc.56.11.878.
PubMed 7305432Baqui AH, Darmstadt GL, Williams EK, Kumar V, Kiran TU, Panwar D, Srivastava VK, Ahuja R, Black RE, Santosham M. Rates, timing and causes of neonatal deaths in rural India: implications for neonatal health programmes. Bull World Health Organ. 2006 Sep;84(9):706-13. doi: 10.2471/blt.05.026443.
PubMed 17128340Darmstadt GL, Bhutta ZA, Cousens S, Adam T, Walker N, de Bernis L; Lancet Neonatal Survival Steering Team. Evidence-based, cost-effective interventions: how many newborn babies can we save? Lancet. 2005 Mar 12-18;365(9463):977-88. doi: 10.1016/S0140-6736(05)71088-6.
PubMed 15767001Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.
PubMed 15752534Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha S, Adhikari R, Tielsch JM. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet. 2006 Mar 18;367(9514):910-8. doi: 10.1016/S0140-6736(06)68381-5.
PubMed 16546539Mullany LC, Darmstadt GL, Tielsch JM. Safety and impact of chlorhexidine antisepsis interventions for improving neonatal health in developing countries. Pediatr Infect Dis J. 2006 Aug;25(8):665-75. doi: 10.1097/01.inf.0000223489.02791.70.
PubMed 16874163Mitra DK, Mullany LC, Harrison M, Mannan I, Shah R, Begum N, Moin MI, El Arifeen S, Baqui AH; Projahnmo Study Group in Bangladesh. Incidence and risk factors of neonatal infections in a rural Bangladeshi population: a community-based prospective study. J Health Popul Nutr. 2018 Mar 9;37(1):6. doi: 10.1186/s41043-018-0136-2.
PubMed 29523194Mullany LC, Shah R, El Arifeen S, Mannan I, Winch PJ, Hill A, Darmstadt GL, Baqui AH. Chlorhexidine cleansing of the umbilical cord and separation time: a cluster-randomized trial. Pediatrics. 2013 Apr;131(4):708-15. doi: 10.1542/peds.2012-2951. Epub 2013 Mar 18.
PubMed 23509175Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MR, Begum N, Al-Kabir A, Darmstadt GL, Santosham M, Black RE, Baqui AH. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1022-8. doi: 10.1016/S0140-6736(11)61848-5. Epub 2012 Feb 8.
PubMed 22322124Mullany LC, El Arifeen S, Winch PJ, Shah R, Mannan I, Rahman SM, Rahman MR, Darmstadt GL, Ahmed S, Santosham M, Black RE, Baqui AH. Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial. BMC Pediatr. 2009 Oct 21;9:67. doi: 10.1186/1471-2431-9-67.
PubMed 19845951
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Umbilical Cord Cleansing With Chlorhexidine on Neonatal Mortality and Omphalitis in Rural Sylhet District of Bangladesh
- ClinicalTrials.gov ID
- NCT00434408
- Acronym / sponsor ID
- CHX / IRB00000146
- Conditions
- Omphalitis, Infection
- Keywords
- omphalitis, neonates, umbilical cord, infection, infant mortality, neonate morbidity, chlorhexidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28,797 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Government of Bangladesh, International Centre for Diarrhoeal Disease Research, Bangladesh, Save the Children, Shimantik
- Study start
- May 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Feb 2007 (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.
A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution
Detailed description
Of the annual four million neonatal deaths, 99% occur in developing countries, and more than one-third globally can be attributed to infections. In areas with high-mortality rates, the proportion attributable to infections is as high as 50%. Many infections in infants can be prevented or treated with already existing measures, yet finding the best way to provide these measures in communities that are limited in resources need to be identified. Applying chlorhexidine to the umbilical cord of newborns may be a simple way to help reduce neonatal mortality and morbidity in the community at low cost.
A study by our group was recently completed in Nepal. It was a large community-based, factorial-designed trial in southern Nepal to: (1) assess the impact of newborn total body skin cleansing with 0.25% chlorhexidine on neonatal mortality and morbidity and (2) assess the impact of cleansing of the umbilical stump with 4% chlorhexidine on omphalitis and neonatal mortality.
The results of these studies have suggested that chlorhexidine antisepsis interventions may significantly reduce neonatal mortality and omphalitis. A single full body cleansing of the neonate with chlorhexidine as soon as possible after birth reduced mortality among low birth weight (LBW) infants by 28%. Repeated cleansing of the umbilical stump with chlorhexidine reduced the rate of severe cord infection by 75% and, if this treatment was begun within the first 24 hours following birth, reduced neonatal mortality by 34%.
In rural Bangladesh, over 90% of women deliver at home with only untrained local women or family members in attendance, and low birth weight babies are delivered approximately 30% of the time. The overall neonatal mortality rate exceeds 36 per 1000 live births and in order to reduce this burden, simple, cost-effective interventions that can be delivered at the community level are urgently needed. Given the potential impact of repeated chlorhexidine cleansing of the cord demonstrated in the Nepal trial, a replication study of this regimen and further investigations of more simple regimens are necessary. The number of treatments necessary to reduce neonatal mortality has important programmatic implications for who can deliver the intervention, and how it is packaged.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: CHX x 7 days4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth |
| 2 | Experimental | Behavioral: chx once4.0% chlorhexidine cleansing of the cord applied once by a project worker visiting the newborn in the home as soon as possible after birth |
| 3 | Active comparator | Behavioral: dry cord caredry cord care |
Who may qualify
- Ages
- 1 minute to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- live-born infants delivered in one of three upazillas of Sylhet District (Zakiganj, Khanaighat, Beanibazar)
- married women of reproductive age within their individual target areas listed above
Key exclusion criteria (2 listed)
- individuals outside of the target area in Sylhet(Zakiganj, Khanaighat, Beanibazar)
- infants not met at home by a project worker during the first seven days 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 |
|---|---|---|
| chx once4.0% chlorhexidine cleansing of the cord applied once by a project worker visiting the newborn in the home as soon as possible after birth | Behavioural | 2 |
| CHX x 7 days4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth | Behavioural | 1 |
| dry cord careHousehold members are instructed to apply nothing to the newborn's umbilical cord stump. | Behavioural | 3 |
Primary outcome
neonatal mortality
Time frame: 3 Month intervals
omphalitis among live born infants.
Time frame: 3 Month intervals
3 secondary outcomes
newborn care practices
Time frame: 3 Years
care seeking behaviors
Time frame: 3 Years
morbidity measures, including sepsis and omphalitis
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Background: PubMed 7305432Aggett PJ, Cooper LV, Ellis SH, McAinsh J. Percutaneous absorption of chlorhexidine in neonatal cord care. Arch Dis Child. 1981 Nov;56(11):878-80. doi: 10.1136/adc.56.11.878.
- Background: PubMed 17128340Baqui AH, Darmstadt GL, Williams EK, Kumar V, Kiran TU, Panwar D, Srivastava VK, Ahuja R, Black RE, Santosham M. Rates, timing and causes of neonatal deaths in rural India: implications for neonatal health programmes. Bull World Health Organ. 2006 Sep;84(9):706-13. doi: 10.2471/blt.05.026443.
- Background: PubMed 15767001Darmstadt GL, Bhutta ZA, Cousens S, Adam T, Walker N, de Bernis L; Lancet Neonatal Survival Steering Team. Evidence-based, cost-effective interventions: how many newborn babies can we save? Lancet. 2005 Mar 12-18;365(9463):977-88. doi: 10.1016/S0140-6736(05)71088-6.
- Background: PubMed 15752534Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.
- Background: PubMed 16546539Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha S, Adhikari R, Tielsch JM. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet. 2006 Mar 18;367(9514):910-8. doi: 10.1016/S0140-6736(06)68381-5.
- Background: PubMed 16874163Mullany LC, Darmstadt GL, Tielsch JM. Safety and impact of chlorhexidine antisepsis interventions for improving neonatal health in developing countries. Pediatr Infect Dis J. 2006 Aug;25(8):665-75. doi: 10.1097/01.inf.0000223489.02791.70.
- Derived from this study: PubMed 29523194Mitra DK, Mullany LC, Harrison M, Mannan I, Shah R, Begum N, Moin MI, El Arifeen S, Baqui AH; Projahnmo Study Group in Bangladesh. Incidence and risk factors of neonatal infections in a rural Bangladeshi population: a community-based prospective study. J Health Popul Nutr. 2018 Mar 9;37(1):6. doi: 10.1186/s41043-018-0136-2.
- Derived from this study: PubMed 23509175Mullany LC, Shah R, El Arifeen S, Mannan I, Winch PJ, Hill A, Darmstadt GL, Baqui AH. Chlorhexidine cleansing of the umbilical cord and separation time: a cluster-randomized trial. Pediatrics. 2013 Apr;131(4):708-15. doi: 10.1542/peds.2012-2951. Epub 2013 Mar 18.
- Derived from this study: PubMed 22322124Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MR, Begum N, Al-Kabir A, Darmstadt GL, Santosham M, Black RE, Baqui AH. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1022-8. doi: 10.1016/S0140-6736(11)61848-5. Epub 2012 Feb 8.
- Derived from this study: PubMed 19845951Mullany LC, El Arifeen S, Winch PJ, Shah R, Mannan I, Rahman SM, Rahman MR, Darmstadt GL, Ahmed S, Santosham M, Black RE, Baqui AH. Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial. BMC Pediatr. 2009 Oct 21;9:67. doi: 10.1186/1471-2431-9-67.
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.
Abdullah H Baqui, MBBS, DrPH principal investigator
Johns Hopkins Bloomberg School of Public Health
Shams El Arifeen principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chx once, CHX x 7 days and dry cord care in people with Omphalitis and Infection, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
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 2 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 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
neonatal mortality (time frame: 3 Month intervals). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00434408, which also lists 10 linked publications.
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 5 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.