Neonatal MortalityPhase 3CHX-PembaNCT01528852
Chlorhexidine Cordcare for Reduction in Neonatal Mortality and Omphalitis
A Phase 3 study testing Chlorhexidine 4% in people with Neonatal Mortality and Cord Care, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Tanzania.
Trial summary
In a community-based controlled trial among children to evaluate if use of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life results in Reduction in neonatal mortality (deaths in first 28 days of life) Reduction in umbilical cord infections (defined by moderate or severe redness… Read more about this study
- Who is it for?
- Ages 1 hour to 48 hours
- Conditions the study is for
- Neonatal Mortality, Cord Care, Omphalitis
- What is being tested?
- Chlorhexidine 4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36,911 participants
- Where
- 1 siteTanzania
- Study dates
- 19 May 2011to 29 Sep 2014
- 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 hour to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Permanent resident of Pemba
- Consenting to participate, infants alive at first contact with MCH/TBA/Hospital staff
- First contact within 48 hours of delivery.
Who cannot join
- Congenital malformations where application of intervention is not possible
- Very sick child needing hospitalization and ICU care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Use of Chlorhexidine to Clean Umbilical Cord of Neonates in First 10 Days for Reduction in Neonatal Mortality and Omphalitis - A Community Based Randomized, Double Masked Controlled Trial in Pemba Tanzania
In a community-based controlled trial among children to evaluate if use of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life results in
- Reduction in neonatal mortality (deaths in first 28 days of life)
- Reduction in umbilical cord infections (defined by moderate or severe redness of the cord) during first 28 days of life
- Reduction in umbilical cord infections (defined by pus formation with any degree of redness) during first 28 days of life.
The double blind part of study uses a control preparation without chlorhexidine (CHX) as control group while in the sub-study dry cord care group is also evaluated as second control. Hypothesis is that CHX group will have lower mortality and umbilical cord infections while control group and dry cord group will be similar as shown in a previous study in Nepal.
Read the detailed description
Project Goal: The purpose of the trial is to evaluate the efficacy of cord cleansing with Chlorhexidine in the first 10 days of life in reducing neonatal mortality and morbidity. The study would provide a proof of principle for an intervention that could easily be scaled up.
Objectives of formative phase:
- Using TIPS (Trials of Improved Practices) methodology to evaluate the acceptance and impediments if any to practice of using liquid solution for cord cleaning including washing of hands with soap before and after use.
- To compare 3 modes (3 different packaging with application using cotton ball, dropper bottle and squeeze tube) of delivery for cord cleaning in terms of acceptance, ease of use and effectiveness in covering the target area.
Objectives of the main Trial :
Primary Objectives: In a double-blind community-based randomized controlled trial among 24,000 children to evaluate the efficacy of application of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life compared to infants cleansed with a similar control solution without Chlorhexidine for:
- Reduction in neonatal mortality (deaths in first 28 days of life).
- Reduction in umbilical cord infections (defined by moderate or severe redness of the cord) during first 28 days of life.
- Reduction in umbilical cord infections (defined by pus formation with any degree of redness) during first 28 days of life.
Secondary Objectives: In a nested sub-study among 12,000 births (8000 from 24,000 double blind main study and 4000 additional births) randomized to three groups: Chlorhexidine cord care (n=4000), control solution cord care (n=4000) and dry cord care (n=4000):
- To evaluate the sensitivity and specificity of traditionally used "field definitions of omphalitis" based on a combination of signs and symptom in comparison to culture results using state of art sample collection/transport, culture and bacterial identification.
- To evaluate reductions in bacterial colonization rates from a) umbilical cord tip, b) stump and base area in Chlorhexidine and Control Solution groups compared to currently recommended dry cord care.
- Conditions
- Neonatal Mortality, Cord Care, Omphalitis
- Being tested
- Chlorhexidine 4%, Control cord cleaning solution
- Keywords
- neonatal Mortality, chlorhexidine cord care, cord infections, african settings, clinical trials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine 4%Drug
4% liquid solution used for cord cleaning once daily for 10 days
Chlorhexidine 4%Drug
Chlorhexidine 4% liquid solution used for cord cleaning once daily for 10 days
Control cord cleaning solutionOther
Mild soapy solution used to clean cord once daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| CHX Cord application | Experimental | Chlorhexidine cord application for 10 days Receives: Drug: Chlorhexidine 4% |
| Control | Active comparator | Same liquid as intervention without the chlorhexidine used for cord cleaning for 10 days once daily Receives: Other: Control cord cleaning solution |
| Dry Cord care | No intervention | Use current recommended keep cord dry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Mortality
Measured: 28 days after birth
Secondary outcomes (1)
Omphalitis
Using two field based definitions presence of redness or swelling with or without PUS.
Measured: Birth to 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study start19 May 2011
- Primary completion29 Sep 2014
- Study completion29 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal MortalityStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36,911 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Annamalai University, Ministry of Health and Social Welfare, Zanzibar, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528852
- Sponsor's protocol ID
- 00003027
- Acronym
- CHX-Pemba
- Status last verified
- Aug 2023
- First submitted
- 3 Feb 2012
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sazawal S, Dhingra U, Ali SM, Dutta A, Deb S, Ame SM, Mkasha MH, Yadav A, Black RE. Efficacy of chlorhexidine application to umbilical cord on neonatal mortality in Pemba, Tanzania: a community-based randomised controlled trial. Lancet Glob Health. 2016 Nov;4(11):e837-e844. doi: 10.1016/S2214-109X(16)30223-6. Epub 2016 Sep 29.
PubMed 27693438Nangia S, Dhingra U, Dhingra P, Dutta A, Menon VP, Black RE, Sazawal S. Effect of 4 % chlorhexidine on cord colonization among hospital and community births in India: a randomized controlled study. BMC Pediatr. 2016 Aug 2;16:121. doi: 10.1186/s12887-016-0625-7.
PubMed 27484013Dhingra U, Sazawal S, Dhingra P, Dutta A, Ali SM, Ame SM, Deb S, Suleiman AM, Black RE. Trial of improved practices approach to explore the acceptability and feasibility of different modes of chlorhexidine application for neonatal cord care in Pemba, Tanzania. BMC Pregnancy Childbirth. 2015 Dec 28;15:354. doi: 10.1186/s12884-015-0760-4.
PubMed 26711437Dhingra U, Gittelsohn J, Suleiman AM, Suleiman SM, Dutta A, Ali SM, Gupta S, Black RE, Sazawal S. Delivery, immediate newborn and cord care practices in Pemba Tanzania: a qualitative study of community, hospital staff and community level care providers for knowledge, attitudes, belief systems and practices. BMC Pregnancy Childbirth. 2014 May 22;14:173. doi: 10.1186/1471-2393-14-173.
PubMed 24885689
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Use of Chlorhexidine to Clean Umbilical Cord of Neonates in First 10 Days for Reduction in Neonatal Mortality and Omphalitis - A Community Based Randomized, Double Masked Controlled Trial in Pemba Tanzania
- ClinicalTrials.gov ID
- NCT01528852
- Acronym / sponsor ID
- CHX-Pemba / 00003027
- Conditions
- Neonatal Mortality, Cord Care, Omphalitis
- Keywords
- neonatal Mortality, chlorhexidine cord care, cord infections, african settings, clinical trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36,911 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Annamalai University, Ministry of Health and Social Welfare, Zanzibar, Bill and Melinda Gates Foundation
- Study start
- 19 May 2011 (actual)
- Primary completion
- 29 Sep 2014 (actual)
- Study completion
- 29 Sep 2014 (actual)
- First posted
- 8 Feb 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.
In a community-based controlled trial among children to evaluate if use of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life results in
- Reduction in neonatal mortality (deaths in first 28 days of life)
- Reduction in umbilical cord infections (defined by moderate or severe redness of the cord) during first 28 days of life
- Reduction in umbilical cord infections (defined by pus formation with any degree of redness) during first 28 days of life.
The double blind part of study uses a control preparation without chlorhexidine (CHX) as control group while in the sub-study dry cord care group is also evaluated as second control. Hypothesis is that CHX group will have lower mortality and umbilical cord infections while control group and dry cord group will be similar as shown in a previous study in Nepal.
Detailed description
Project Goal: The purpose of the trial is to evaluate the efficacy of cord cleansing with Chlorhexidine in the first 10 days of life in reducing neonatal mortality and morbidity. The study would provide a proof of principle for an intervention that could easily be scaled up.
Objectives of formative phase:
- Using TIPS (Trials of Improved Practices) methodology to evaluate the acceptance and impediments if any to practice of using liquid solution for cord cleaning including washing of hands with soap before and after use.
- To compare 3 modes (3 different packaging with application using cotton ball, dropper bottle and squeeze tube) of delivery for cord cleaning in terms of acceptance, ease of use and effectiveness in covering the target area.
Objectives of the main Trial :
Primary Objectives: In a double-blind community-based randomized controlled trial among 24,000 children to evaluate the efficacy of application of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life compared to infants cleansed with a similar control solution without Chlorhexidine for:
- Reduction in neonatal mortality (deaths in first 28 days of life).
- Reduction in umbilical cord infections (defined by moderate or severe redness of the cord) during first 28 days of life.
- Reduction in umbilical cord infections (defined by pus formation with any degree of redness) during first 28 days of life.
Secondary Objectives: In a nested sub-study among 12,000 births (8000 from 24,000 double blind main study and 4000 additional births) randomized to three groups: Chlorhexidine cord care (n=4000), control solution cord care (n=4000) and dry cord care (n=4000):
- To evaluate the sensitivity and specificity of traditionally used "field definitions of omphalitis" based on a combination of signs and symptom in comparison to culture results using state of art sample collection/transport, culture and bacterial identification.
- To evaluate reductions in bacterial colonization rates from a) umbilical cord tip, b) stump and base area in Chlorhexidine and Control Solution groups compared to currently recommended dry cord care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHX Cord application | Experimental | Drug: Chlorhexidine 4%Chlorhexidine cord application for 10 days |
| Control | Active comparator | Other: Control cord cleaning solutionSame liquid as intervention without the chlorhexidine used for cord cleaning for 10 days once daily |
| Dry Cord care | No intervention | –Use current recommended keep cord dry |
Who may qualify
- Ages
- 1 hour to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Permanent resident of Pemba
- Consenting to participate, infants alive at first contact with MCH/TBA/Hospital staff
- First contact within 48 hours of delivery.
Key exclusion criteria (2 listed)
- Congenital malformations where application of intervention is not possible
- Very sick child needing hospitalization and ICU care.
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 |
|---|---|---|
| Chlorhexidine 4%4% liquid solution used for cord cleaning once daily for 10 days | Drug | CHX Cord application |
| Chlorhexidine 4%Chlorhexidine 4% liquid solution used for cord cleaning once daily for 10 days | Drug | CHX Cord application |
| Control cord cleaning solutionMild soapy solution used to clean cord once daily for 10 days | Other | Control |
Primary outcome
Neonatal Mortality
Time frame: 28 days after birth
1 secondary outcome
Omphalitis
Time frame: Birth to 28 days of life
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 28 Aug 2023.
- Results publication: PubMed 27693438Sazawal S, Dhingra U, Ali SM, Dutta A, Deb S, Ame SM, Mkasha MH, Yadav A, Black RE. Efficacy of chlorhexidine application to umbilical cord on neonatal mortality in Pemba, Tanzania: a community-based randomised controlled trial. Lancet Glob Health. 2016 Nov;4(11):e837-e844. doi: 10.1016/S2214-109X(16)30223-6. Epub 2016 Sep 29.
- Derived from this study: PubMed 27484013Nangia S, Dhingra U, Dhingra P, Dutta A, Menon VP, Black RE, Sazawal S. Effect of 4 % chlorhexidine on cord colonization among hospital and community births in India: a randomized controlled study. BMC Pediatr. 2016 Aug 2;16:121. doi: 10.1186/s12887-016-0625-7.
- Derived from this study: PubMed 26711437Dhingra U, Sazawal S, Dhingra P, Dutta A, Ali SM, Ame SM, Deb S, Suleiman AM, Black RE. Trial of improved practices approach to explore the acceptability and feasibility of different modes of chlorhexidine application for neonatal cord care in Pemba, Tanzania. BMC Pregnancy Childbirth. 2015 Dec 28;15:354. doi: 10.1186/s12884-015-0760-4.
- Derived from this study: PubMed 24885689Dhingra U, Gittelsohn J, Suleiman AM, Suleiman SM, Dutta A, Ali SM, Gupta S, Black RE, Sazawal S. Delivery, immediate newborn and cord care practices in Pemba Tanzania: a qualitative study of community, hospital staff and community level care providers for knowledge, attitudes, belief systems and practices. BMC Pregnancy Childbirth. 2014 May 22;14:173. doi: 10.1186/1471-2393-14-173.
- Efficacy of chlorhexidine application to umbilical cord on neonatal mortality in Pemba, Tanzania: a community-based randomised controlled trialLink 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chlorhexidine 4% in people with Neonatal Mortality and Cord Care, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Tanzania.
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 3 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 28 Aug 2023. 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 Tanzania. 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: 28 days after birth). 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 NCT01528852, which also lists 4 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 28 Aug 2023.