OmphalitisNCT02624622
Chlorhexidine Cord Care for Newborn Infants in Kenya
A study testing Chlorhexidine application to cord by mother and Chlorhexidine application by CHW in people with Omphalitis, run by University of New Mexico at 1 site in United States.
Trial summary
Studies in several countries with a high rate of death of infants during the first week of life have found a reduction in infection and mortality when chlorhexidine is applied to the umbilical cord stump by a health worker within 24 hours of birth. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Omphalitis
- What is being tested?
- Chlorhexidine application to cord by mother and Chlorhexidine application by CHW
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jan 2017
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: All pregnant women who are 18 years of age or older (based on their stated date of birth) who attend the two selected health care facilities (Kisesini Dispensary and Katangi Health Center) for their prenatal care will be eligible to participate if they reside in one of the villages of the five sublocations of the target region (Kyua, Makusya, Katangi, Mekilingi, Syokisinga) and they plan to deliver within the target region -
Exclusion Criteria: Pregnant women who plan to deliver outside of the target area or plan to be away from the area during the newborn infant's first week of life will be excluded
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Mothers and Community Health Workers on Use of Chlorhexidine for Umbilical Cord Care: A Randomized Noninferiority Trial
Studies in several countries with a high rate of death of infants during the first week of life have found a reduction in infection and mortality when chlorhexidine is applied to the umbilical cord stump by a health worker within 24 hours of birth. This study will evaluate if providing chlorhexidine to pregnant women during a prenatal care visit for application to the cord stump after birth will be as effective for preventing omphalitis (infection of the umbilical cord stump) as sending a community health worker into the home to apply the chlorhexidine.
Read the detailed description
Neonatal mortality continues to be unacceptably high in Kenya and other Sub-Saharan African countries, with little improvement over the past several decades. Neonatal infections and sepsis are a leading cause of neonatal deaths. Three fourths of these deaths occur in the first week of life. Many deliveries in rural Kenya take place at home in unhygienic conditions and the umbilical cord is cut with unsterile instruments, increasing the risk of infection. Studies in several countries with a high neonatal mortality rate have found a reduction in infection and mortality when chlorhexidine is applied to the umbilical cord stump by a health worker within 24 hours of birth. This randomized noninferiority study in rural Kenya will compare the effectiveness of a newborn home visitation program that includes application of chlorhexidine to the umbilical cord by a visiting community health worker (CHW) to the provision of chlorhexidine to the mother during a prenatal care visit for cord application on the rate of omphalitis (infection of the umbilical cord stump) during the first week of life. Pregnant women will be randomly assigned in a 1:1 ration to be given or not be given chlorhexidine digluconate 7.1% gel during a prenatal care visit with instruction to apply the product as soon as possible after birth. The pregnant women who do not receive the chlorhexidine will be assigned a CHW with instruction to apply the product during a home visit within 24 hours of birth. The rate of omphalitis will be determined during home visits by the CHW on days three and seven after birth, and by a visiting research nurse on the seventh day. The time from birth to chlorhexidine application will also be recorded and compared in the two groups.
- Conditions
- Omphalitis
- Being tested
- Chlorhexidine application to cord by mother, Chlorhexidine application by CHW
- Keywords
- omphalitis, neonate, developing countries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine application to cord by motherProcedure or surgery
Chlorhexidine application by CHWProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CHW applies chlorhexidine | Active comparator | Intervention: Chlorhexidine gel 7.1% topical 3 gm applied to the umbilical cord stump in one application. The community health worker is given the chlorhexidine to apply to the umbilical cord stump within 24 hours of delivery of the newborn infant. Receives: Procedure: Chlorhexidine application by CHW |
| Mother applies chlorhexidine | Experimental | Intervention: Chlorhexidine gel 7.1% topical 3 gm applied to the umbilical cord stump in one application. Mother is given the chlorhexidine during the first prenatal care visit to apply to the umbilical cord stump within 24 hours of delivery of the newborn infant. Receives: Procedure: Chlorhexidine application to cord by mother |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infants age 0 to 7 days who develop omphalitis
Omphalitis is defined as redness of the umbilical stump that extends to the skin of the abdomen with or without purulent exudate (pus).
Measured: 7 days after birth
Secondary outcomes (1)
The average time in minutes from birth to chlorhexidine application (total time for all participants in the arm divided by total participants in the arm).
The duration in minutes from the recorded birth time until the recorded time that chlorhexidine is applied to the umbilical cord stump
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nairobi
- Responsible party
- Principal investigator, Angelo Tomedi, University of New Mexico
- Investigators
- ANGELO TOMEDI, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624622
- Sponsor's protocol ID
- UNM HRRC 14-356
- Status last verified
- May 2018
- First submitted
- 3 Dec 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Mothers and Community Health Workers on Use of Chlorhexidine for Umbilical Cord Care: A Randomized Noninferiority Trial
- ClinicalTrials.gov ID
- NCT02624622
- Acronym / sponsor ID
- UNM HRRC 14-356
- Conditions
- Omphalitis
- Keywords
- omphalitis, neonate, developing countries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funds
- Enrolment
- 576 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- University of Nairobi
- Study start
- Mar 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 8 Dec 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.
Studies in several countries with a high rate of death of infants during the first week of life have found a reduction in infection and mortality when chlorhexidine is applied to the umbilical cord stump by a health worker within 24 hours of birth. This study will evaluate if providing chlorhexidine to pregnant women during a prenatal care visit for application to the cord stump after birth will be as effective for preventing omphalitis (infection of the umbilical cord stump) as sending a community health worker into the home to apply the chlorhexidine.
Detailed description
Neonatal mortality continues to be unacceptably high in Kenya and other Sub-Saharan African countries, with little improvement over the past several decades. Neonatal infections and sepsis are a leading cause of neonatal deaths. Three fourths of these deaths occur in the first week of life. Many deliveries in rural Kenya take place at home in unhygienic conditions and the umbilical cord is cut with unsterile instruments, increasing the risk of infection. Studies in several countries with a high neonatal mortality rate have found a reduction in infection and mortality when chlorhexidine is applied to the umbilical cord stump by a health worker within 24 hours of birth. This randomized noninferiority study in rural Kenya will compare the effectiveness of a newborn home visitation program that includes application of chlorhexidine to the umbilical cord by a visiting community health worker (CHW) to the provision of chlorhexidine to the mother during a prenatal care visit for cord application on the rate of omphalitis (infection of the umbilical cord stump) during the first week of life. Pregnant women will be randomly assigned in a 1:1 ration to be given or not be given chlorhexidine digluconate 7.1% gel during a prenatal care visit with instruction to apply the product as soon as possible after birth. The pregnant women who do not receive the chlorhexidine will be assigned a CHW with instruction to apply the product during a home visit within 24 hours of birth. The rate of omphalitis will be determined during home visits by the CHW on days three and seven after birth, and by a visiting research nurse on the seventh day. The time from birth to chlorhexidine application will also be recorded and compared in the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHW applies chlorhexidine | Active comparator | Procedure: Chlorhexidine application by CHWIntervention: Chlorhexidine gel 7.1% topical 3 gm applied to the umbilical cord stump in one application. The community health worker is given the chlorhexidine to apply to the umbilical cord stump within 24 hours of delivery of the newborn infant. |
| Mother applies chlorhexidine | Experimental | Procedure: Chlorhexidine application to cord by motherIntervention: Chlorhexidine gel 7.1% topical 3 gm applied to the umbilical cord stump in one application. Mother is given the chlorhexidine during the first prenatal care visit to apply to the umbilical cord stump within 24 hours of delivery of the newborn infant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 application to cord by mother | Procedure or surgery | Mother applies chlorhexidine |
| Chlorhexidine application by CHW | Procedure or surgery | CHW applies chlorhexidine |
Primary outcome
Number of infants age 0 to 7 days who develop omphalitis
Time frame: 7 days after birth
Omphalitis is defined as redness of the umbilical stump that extends to the skin of the abdomen with or without purulent exudate (pus).
1 secondary outcome
The average time in minutes from birth to chlorhexidine application (total time for all participants in the arm divided by total participants in the arm).
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Lack of funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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.
ANGELO TOMEDI, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine application to cord by mother and Chlorhexidine application by CHW in people with Omphalitis, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 11 May 2018. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of funds). Results are not available in the source record.
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?
Number of infants age 0 to 7 days who develop omphalitis (time frame: 7 days after birth). 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 11 May 2018.