OmphalitisPhase 4NCT02606565
Efficacy of Umbilical Cord Cleansing With a Single Application of 4% Chlorhexidine for the Prevention of Newborn Infections in Uganda: a Randomized Controlled Trial
A Phase 4 study testing Intervention arm: 4% chlorhexidine in people with Omphalitis and Septicaemia, run by Makerere University at 1 site in Uganda.
Trial summary
Background: Nearly all the yearly 3.3 million neonatal deaths occur in low and middle income countries. Infections, including those affecting the umbilical cord (omphalitis) are a significant factor in approximately a third of these deaths. Read more about this study
- Who is it for?
- Ages Up to 2 daysHealthy volunteers can take part
- Conditions the study is for
- Omphalitis, Septicaemia
- What is being tested?
- Intervention arm: 4% chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,760 participants
- Where
- 1 siteUganda
- Study dates
- Jul 2016to 1 Oct 2020
- Phase
- Phase 4
- 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 2 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborns weighing 1.5kg or more at birth
- Newborns born to mothers whose HIV I status is negative
Who cannot join
- Newborns with severe congenital anomalies
- Newborns with infection of the umbilical cord at birth
- Twins or triplets
- Severely ill infants requiring hospitalization immediately after birth
- Children of mothers who cannot appropriately give consent within 12 h of birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability and Efficacy of Umbilical Cord Cleansing With 4% Chlorhexidine for the Prevention of Newborn Infections in Lira District, Northern Uganda: A Randomised Controlled Trial
Background: Nearly all the yearly 3.3 million neonatal deaths occur in low and middle income countries. Infections, including those affecting the umbilical cord (omphalitis) are a significant factor in approximately a third of these deaths. In fact, the odds of all-cause mortality are 46% higher among infants with umbilical cord infection than those without infection. Five large randomized controlled trials in Asia and Sub-Saharan Africa have examined the effect of multiple applications (for at least 7 days) of 4% chlorhexidine (CHX) on the umbilical cord on omphalitis and neonatal death. These studies show a consitent positive effect of multiple applications on omphalitis but not on neonatal mortality. Whereas there is mounting evidence for the effect of 7 day chlorhexidine application, there is no data from Africa and only one study from Asia that examines the effect of a single application of CHX as soon as possible after birth. In this single Asian study, CHX led to a reduction in the risk of mild-moderate omphalitis and neonatal death. It is important, in an African setting to explore the effect of a single application, which is programmatically much simpler to implement than daily application for 7 days. Therefore, the investigators' study will compare umbilical cord cleansing with a single application of 4% chlorhexidine at birth with dry cord care in both community and facility births on omphalitis and severe illness in the neonatal period.
Methods: The chlorhexidine study is a community based, individually randomised controlled trial conducted on 4,760 mother-infant pairs in Uganda. The primary outcomes are severe illness and umbilical cord infection (omphalitis). Severe illness is defined as any illness associated with at least one of the following danger signs observed by study research assistants: inability to drink or breastfeed or (a history of) convulsions, lethargy or unconsciousness, vomiting of all feeds, and/or results in hospitalization and/or results in death.
Discussion: This study will provide novel evidence, from a Sub-Saharan African setting of the effect of umbilical cord cleansing with a single application of 4% chlorhexidine at birth in both community and facility births.
- Conditions
- Omphalitis, Septicaemia
- Being tested
- Intervention arm: 4% chlorhexidine
- Medical subject headings
- Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention arm: 4% chlorhexidineBiological
See previous description
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm: 4% chlorhexidine | Experimental | Neonates randomized to the chlorhexidine arm will have umbilical stump cleansing with a single application of 4% chlorhexidine solution at birth Receives: Biological: Intervention arm: 4% chlorhexidine |
| Control arm: Dry cord care | No intervention | Neonates randomized to the control arm will receive the current standard of cord care (dry cord care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of infants with severe illness
Severe illness will be defined as an acute illness that is associated with any of the following danger signs observed or verified by a study clinician: inability to feed or vomiting of everything and unable to keep anything down, lethargy or unconsciousness, severe lower chest in-drawing, axillary temperature of ≥38.0 degrees Celsius or <35.5 degrees Celsius, grunting, cyanosis, convulsions or a history of convulsions, and/or results in hospitalization and/or results in death. Hospitalization and death resulting from violent injury or burns will not contribute to the severe illness definition.
Measured: First 28 days of life
Proportion of infants with omphalitis
This outcome will be recorded as present or absent based on specific signs. These include: pus, redness (inflammation) and swelling (oedema) of the cord stump and the surrounding skin at its base. Swelling and redness will be further broken down into: none, mild, moderate and severe. No swelling or redness will be the absence of visible swelling or redness; mild swelling or redness as that limited to the cord stump only; moderate swelling or redness as that extending less than 2cm onto the abdominal skin at the base of the stump and severe swelling or redness as extending ≥2cm into the abdominal skin at the base of the stump. Pus will be defined as either present or absent. Cord infection will then be defined based on combinations of these recorded signs and their severity into four categories as follows: 1) redness extending to skin or pus, 2) moderate or severe redness, 3) moderate or severe redness with pus, or severe redness alone and 4) Severe redness with pus.
Measured: First 28 days of life
Secondary outcomes (2)
Death
Measured: First 28 days of life
Adverse events
Measured: First 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 posted17 Nov 2015 (estimated)
- Study startJul 2016
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OmphalitisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre For International Health
- Responsible party
- Sponsor
- Investigators
- Victoria Nankabirwa, MD, MPH, PhD, Principal investigator, Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606565
- Sponsor's protocol ID
- 2015-118
- Status last verified
- Apr 2025
- First submitted
- 12 Nov 2015
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Imdad A, Bautista RM, Senen KA, Uy ME, Mantaring JB 3rd, Bhutta ZA. Umbilical cord antiseptics for preventing sepsis and death among newborns. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008635. doi: 10.1002/14651858.CD008635.pub2.
PubMed 23728678Nankabirwa V, Tylleskar T, Tumuhamye J, Tumwine JK, Ndeezi G, Martines JC, Sommerfelt H. Efficacy of umbilical cord cleansing with a single application of 4% chlorhexidine for the prevention of newborn infections in Uganda: study protocol for a randomized controlled trial. Trials. 2017 Jul 12;18(1):322. doi: 10.1186/s13063-017-2050-0.
PubMed 28701228
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Efficacy of Umbilical Cord Cleansing With 4% Chlorhexidine for the Prevention of Newborn Infections in Lira District, Northern Uganda: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02606565
- Acronym / sponsor ID
- 2015-118
- Conditions
- Omphalitis, Septicaemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,760 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Centre For International Health
- Study start
- Jul 2016 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 17 Nov 2015 (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.
Background: Nearly all the yearly 3.3 million neonatal deaths occur in low and middle income countries. Infections, including those affecting the umbilical cord (omphalitis) are a significant factor in approximately a third of these deaths. In fact, the odds of all-cause mortality are 46% higher among infants with umbilical cord infection than those without infection. Five large randomized controlled trials in Asia and Sub-Saharan Africa have examined the effect of multiple applications (for at least 7 days) of 4% chlorhexidine (CHX) on the umbilical cord on omphalitis and neonatal death. These studies show a consitent positive effect of multiple applications on omphalitis but not on neonatal mortality. Whereas there is mounting evidence for the effect of 7 day chlorhexidine application, there is no data from Africa and only one study from Asia that examines the effect of a single application of CHX as soon as possible after birth. In this single Asian study, CHX led to a reduction in the risk of mild-moderate omphalitis and neonatal death. It is important, in an African setting to explore the effect of a single application, which is programmatically much simpler to implement than daily application for 7 days. Therefore, the investigators' study will compare umbilical cord cleansing with a single application of 4% chlorhexidine at birth with dry cord care in both community and facility births on omphalitis and severe illness in the neonatal period.
Methods: The chlorhexidine study is a community based, individually randomised controlled trial conducted on 4,760 mother-infant pairs in Uganda. The primary outcomes are severe illness and umbilical cord infection (omphalitis). Severe illness is defined as any illness associated with at least one of the following danger signs observed by study research assistants: inability to drink or breastfeed or (a history of) convulsions, lethargy or unconsciousness, vomiting of all feeds, and/or results in hospitalization and/or results in death.
Discussion: This study will provide novel evidence, from a Sub-Saharan African setting of the effect of umbilical cord cleansing with a single application of 4% chlorhexidine at birth in both community and facility births.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm: 4% chlorhexidine | Experimental | Biological: Intervention arm: 4% chlorhexidineNeonates randomized to the chlorhexidine arm will have umbilical stump cleansing with a single application of 4% chlorhexidine solution at birth |
| Control arm: Dry cord care | No intervention | –Neonates randomized to the control arm will receive the current standard of cord care (dry cord care) |
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborns weighing 1.5kg or more at birth
- Newborns born to mothers whose HIV I status is negative
Key exclusion criteria (5 listed)
- Newborns with severe congenital anomalies
- Newborns with infection of the umbilical cord at birth
- Twins or triplets
- Severely ill infants requiring hospitalization immediately after birth
- Children of mothers who cannot appropriately give consent within 12 h of birth
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 |
|---|---|---|
| Intervention arm: 4% chlorhexidineSee previous description | Biological | Intervention arm: 4% chlorhexidine |
Primary outcome
Proportion of infants with severe illness
Time frame: First 28 days of life
Severe illness will be defined as an acute illness that is associated with any of the following danger signs observed or verified by a study clinician: inability to feed or vomiting of everything and unable to keep anything down, lethargy or unconsciousness, severe lower chest in-drawing, axillary temperature of ≥38.0 degrees Celsius or <35.5 degrees Celsius, grunting, cyanosis, convulsions or a history of convulsions, and/or results in hospitalization and/or results in death. Hospitalization and death resulting from violent injury or burns will not contribute to the severe illness definition.
Proportion of infants with omphalitis
Time frame: First 28 days of life
This outcome will be recorded as present or absent based on specific signs. These include: pus, redness (inflammation) and swelling (oedema) of the cord stump and the surrounding skin at its base. Swelling and redness will be further broken down into: none, mild, moderate and severe. No swelling or redness will be the absence of visible swelling or redness; mild swelling or redness as that limited to the cord stump only; moderate swelling or redness as that extending less than 2cm onto the abdominal skin at the base of the stump and severe swelling or redness as extending ≥2cm into the abdominal skin at the base of the stump. Pus will be defined as either present or absent. Cord infection will then be defined based on combinations of these recorded signs and their severity into four categories as follows: 1) redness extending to skin or pus, 2) moderate or severe redness, 3) moderate or severe redness with pus, or severe redness alone and 4) Severe redness with pus.
2 secondary outcomes
Death
Time frame: First 28 days of life
Adverse events
Time frame: First 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 6 Apr 2025.
- Results publication: PubMed 23728678Imdad A, Bautista RM, Senen KA, Uy ME, Mantaring JB 3rd, Bhutta ZA. Umbilical cord antiseptics for preventing sepsis and death among newborns. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008635. doi: 10.1002/14651858.CD008635.pub2.
- Derived from this study: PubMed 28701228Nankabirwa V, Tylleskar T, Tumuhamye J, Tumwine JK, Ndeezi G, Martines JC, Sommerfelt H. Efficacy of umbilical cord cleansing with a single application of 4% chlorhexidine for the prevention of newborn infections in Uganda: study protocol for a randomized controlled trial. Trials. 2017 Jul 12;18(1):322. doi: 10.1186/s13063-017-2050-0.
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.
Victoria Nankabirwa, MD, MPH, PhD principal investigator
Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intervention arm: 4% chlorhexidine in people with Omphalitis and Septicaemia, run by Makerere University at 1 site in Uganda.
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 6 Apr 2025. 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 Uganda. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of infants with severe illness (time frame: First 28 days of life). 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 NCT02606565, which also lists 2 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 6 Apr 2025.