Neonatal SEPSISNCT03755635
Neonatal Sepsis at Neonatal Intensive Care Units in Ghana
A study testing The WHO multimodal hand hygiene strategy in people with Neonatal SEPSIS, run by Stephanie Bjerrum at 1 site in Ghana.
Trial summary
Background: Neonatal sepsis is a major contributor to global under five mortality. In developing countries a major proportion of neonatal sepsis is thought to emanate from the healthcare setting, due to challenges in infection prevention practices. Read more about this study
- Who is it for?
- Ages 1 minute to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Neonatal SEPSIS
- What is being tested?
- The WHO multimodal hand hygiene strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,433 participants
- Where
- 1 siteGhana
- Study dates
- 1 Oct 2018to 30 Sep 2019
- 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 1 minute to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Admission NICU
- Birth weight ≥750 Grams
- ≤48 hours of age at time of enrolment
- Consent to participate obtained from legal guardian
Who cannot join
- Neonates with severe congenital malformations
- Neonates who have undergone surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neonatal Sepsis at Neonatal Intensive Care Units of Two Major Referral Hospitals in Ghana
Background: Neonatal sepsis is a major contributor to global under five mortality. In developing countries a major proportion of neonatal sepsis is thought to emanate from the healthcare setting, due to challenges in infection prevention practices.
Aim: To study the epidemiology of neonatal sepsis and evaluate the effect of multimodal infection control interventions on the incidence of neonatal sepsis; and colonization by multidrug resistant Gram negative bacteria (MDRGNB).
Read more
Methods: A controlled before and after interventional trial comprising a 7 month pre- intervention phase, 5 month intervention phase and 7 month post-intervention phase. Neonates admitted at the Neonatal Intensive Care Unit (NICU) at Korle-Bu Teaching Hospital (KBTH) will be enrolled prospectively and followed up for diagnosis of sepsis and outcome of admission. This will be used to describe the epidemiology of neonatal sepsis. Swabs will be collected from a subpopulation of included neonates at intervention site (KBTH) and control site (37 Military Hospital) NICUs to assess colonization of neonates with MDRGNB. Environmental swabs will be collected from surfaces at the NICU to assess MDRGNB contamination of the environment. The intervention comprises infection prevention strategies including implementation of the WHO multimodal hand hygiene strategy. The primary endpoint is incidence of neonatal sepsis.
Expected Outcome: This study will contribute to improved infection prevention practices in the participating NICUs and highlight lessons which other national and regional NICUs may learn from.
Read the detailed description
Background In 2012, it was estimated that approximately 680,000 neonatal deaths in developing countries were due to bacterial infections, with an incidence risk of 7.6% and a case fatality risk of 9.8. A major proportion of neonatal infections are expected to be health-care associated, due to inadequate infrastructure and resources for infection control and prevention. Hospital acquired infections(HAIs) are associated with multi-drug resistant (MDR) bacteria, which increases the risk of therapeutic failure due to the limited choice of available antibiotics. HAIs also lead to extended duration of admission, increased medical costs, morbidity and mortality.
Transmission of MDR bacteria in the hospital environment is thought to be due to unhygienic practices which occur during clinical invasive procedures, (e.g. artificial ventilation, catheter and intravenous line insertion). Neonatal infections may also be due to invasion by colonizing bacteria of the neonate, usually originating from maternal and environmental flora.
According to the WHO, 50% of HAIs are preventable through implementation of infection control practices. The WHO has instituted a multimodal hand hygiene strategy that has been found to improve hand hygiene compliance and reduce the prevalence of HAIs. However, the effectiveness of this strategy in a neonatal intensive care unit (NICU) with high risk of colonization with environmental bacteria has not been studied. In fact, most studies that have examined the potential sources and mode of transmission of organisms that cause neonatal sepsis have been conducted in well-resourced countries.
The hypothesis of the study is that the hospital environment serves as a source of MDR Gram negative bacteria responsible for neonatal colonization and sepsis among patients admitted at the NICU of the KBTH; and that implementation of the multimodal hand hygiene strategy will lead to a reduction in the incidence of neonatal sepsis and colonization by MDR Gram negative bacteria.
Objective To determine the impact of multi-modal infection control interventions on the incidence of neonatal sepsis and colonization by MDR Gram negative bacteria.
Method This study will evaluate the impact of WHO multimodal hand hygiene strategy on the incidence of neonatal sepsis and neonatal colonization by MDR Gram negative bacteria as well as pilot surveillance of neonatal sepsis at the participating sites.
Study setting: Data will be collected at the NICU of the KBTH and the 37 Military Hospital, Accra, Ghana.
Study Design: The study will be a controlled before and after interventional trial with one interventional site (KBTH) and a control site (37 Military hospital). Data will be collected over 19 months with a baseline phase of 7 months; an interventional phase of 5 months; and a post intervention phase of 7 months.
Intervention: The WHO multimodal hand hygiene strategy comprises five essential elements; system change-availability of alcohol-based hand rub at the point of care and/ or access to safe continuous water supply and soap and towels; training and education of healthcare professionals; monitoring of hand hygiene practices and performance feedback; reminders in the workplace; and the creation of a handhygiene safety culture with the participation of both individual healthcare workers and senior hospital managers.
- Conditions
- Neonatal SEPSIS
- Being tested
- The WHO multimodal hand hygiene strategy
- Keywords
- Neonatal sepsis, Infection control, Hand hygiene, WHO multi modal
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The WHO multimodal hand hygiene strategyCombination product
Also called Hand hygiene
Comprises five essential elements; system change-availability of alcohol-based hand rub at the point of care and/ or access to safe continuous water supply and soap and towels; training and education of healthcare professionals; monitoring of hand hygiene practices and performance feedback; reminders in the workplace; and the creation of a hand hygiene safety culture with the participation of both individual healthcare workers and senior hospital managers.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Continuously monitoring of neonatal sepsis under standard of care at one site |
| Hand hygiene | Experimental | The WHO multimodal hand hygiene strategy is implemented at one site Receives: Combination Product: The WHO multimodal hand hygiene strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of neonatal sepsis
Incidence of neonatal sepsis including clinical cases treated as sepsis and cases of neonatal sepsis with confirmed bloodstream infections per 1000 admissions.
Measured: Post-intervention at 7 months
Secondary outcomes (4)
Rate of hand hygiene compliance per opportunity
Hand hygiene events per opportunity for hand hygiene measured by direct observations
Measured: Post-intervention at 7 months
Rate of MDR Gram negative bacteria colonization among neonates
Prevalence of MDR Gram negative bacteria among admitted neonates
Measured: During intervention at 2 months and post-intervention at 7 months
Length of admission in days
Days of admission
Measured: Post-intervention at 7 months
All-cause mortality
Mortality rates during admission
Measured: Post-intervention at 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Oct 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Controlled before and after interventional trial
- Masking
- None (open label)
- Enrolment
- 5,433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanie Bjerrum
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Korle-Bu Teaching Hospital, Accra, Ghana, Copenhagen University Hospital, Rigshospitalet, University of Ghana
- Responsible party
- Sponsor-investigator, Stephanie Bjerrum, University of Copenhagen
- Investigators
- Appiah Korang Labi, MD, Principal investigator, Department of Int. Health and Immunlogy Microbiology, University og CopenhagenJørgen Kurtzhals, Professor, Study director, Department of Int. Health and Immunlogy Microbiology, University og Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755635
- Sponsor's protocol ID
- UM ID: 892333
- Status last verified
- Oct 2021
- First submitted
- 23 Nov 2018
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Labi AK, Enweronu-Laryea CC, Nartey ET, Bjerrum S, Ayibor PK, Andersen LP, Newman MJ, Kurtzhals JAL. Bloodstream Infections at Two Neonatal Intensive Care Units in Ghana: Multidrug Resistant Enterobacterales Undermine the Usefulness of Standard Antibiotic Regimes. Pediatr Infect Dis J. 2021 Dec 1;40(12):1115-1121. doi: 10.1097/INF.0000000000003284.
PubMed 34561387
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Sepsis at Neonatal Intensive Care Units of Two Major Referral Hospitals in Ghana
- ClinicalTrials.gov ID
- NCT03755635
- Acronym / sponsor ID
- UM ID: 892333
- Conditions
- Neonatal SEPSIS
- Keywords
- Neonatal sepsis, Infection control, Hand hygiene, WHO multi modal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,433 participants (actual)
- Lead sponsor
- Stephanie BjerrumUniversity, hospital or other
- Collaborators
- University of Copenhagen, Korle-Bu Teaching Hospital, Accra, Ghana, Copenhagen University Hospital, Rigshospitalet, University of Ghana
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 28 Nov 2018 (actual)
- 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: Neonatal sepsis is a major contributor to global under five mortality. In developing countries a major proportion of neonatal sepsis is thought to emanate from the healthcare setting, due to challenges in infection prevention practices.
Aim: To study the epidemiology of neonatal sepsis and evaluate the effect of multimodal infection control interventions on the incidence of neonatal sepsis; and colonization by multidrug resistant Gram negative bacteria (MDRGNB).
Methods: A controlled before and after interventional trial comprising a 7 month pre- intervention phase, 5 month intervention phase and 7 month post-intervention phase. Neonates admitted at the Neonatal Intensive Care Unit (NICU) at Korle-Bu Teaching Hospital (KBTH) will be enrolled prospectively and followed up for diagnosis of sepsis and outcome of admission. This will be used to describe the epidemiology of neonatal sepsis. Swabs will be collected from a subpopulation of included neonates at intervention site (KBTH) and control site (37 Military Hospital) NICUs to assess colonization of neonates with MDRGNB. Environmental swabs will be collected from surfaces at the NICU to assess MDRGNB contamination of the environment. The intervention comprises infection prevention strategies including implementation of the WHO multimodal hand hygiene strategy. The primary endpoint is incidence of neonatal sepsis.
Expected Outcome: This study will contribute to improved infection prevention practices in the participating NICUs and highlight lessons which other national and regional NICUs may learn from.
Detailed description
Background In 2012, it was estimated that approximately 680,000 neonatal deaths in developing countries were due to bacterial infections, with an incidence risk of 7.6% and a case fatality risk of 9.8. A major proportion of neonatal infections are expected to be health-care associated, due to inadequate infrastructure and resources for infection control and prevention. Hospital acquired infections(HAIs) are associated with multi-drug resistant (MDR) bacteria, which increases the risk of therapeutic failure due to the limited choice of available antibiotics. HAIs also lead to extended duration of admission, increased medical costs, morbidity and mortality.
Transmission of MDR bacteria in the hospital environment is thought to be due to unhygienic practices which occur during clinical invasive procedures, (e.g. artificial ventilation, catheter and intravenous line insertion). Neonatal infections may also be due to invasion by colonizing bacteria of the neonate, usually originating from maternal and environmental flora.
According to the WHO, 50% of HAIs are preventable through implementation of infection control practices. The WHO has instituted a multimodal hand hygiene strategy that has been found to improve hand hygiene compliance and reduce the prevalence of HAIs. However, the effectiveness of this strategy in a neonatal intensive care unit (NICU) with high risk of colonization with environmental bacteria has not been studied. In fact, most studies that have examined the potential sources and mode of transmission of organisms that cause neonatal sepsis have been conducted in well-resourced countries.
The hypothesis of the study is that the hospital environment serves as a source of MDR Gram negative bacteria responsible for neonatal colonization and sepsis among patients admitted at the NICU of the KBTH; and that implementation of the multimodal hand hygiene strategy will lead to a reduction in the incidence of neonatal sepsis and colonization by MDR Gram negative bacteria.
Objective To determine the impact of multi-modal infection control interventions on the incidence of neonatal sepsis and colonization by MDR Gram negative bacteria.
Method This study will evaluate the impact of WHO multimodal hand hygiene strategy on the incidence of neonatal sepsis and neonatal colonization by MDR Gram negative bacteria as well as pilot surveillance of neonatal sepsis at the participating sites.
Study setting: Data will be collected at the NICU of the KBTH and the 37 Military Hospital, Accra, Ghana.
Study Design: The study will be a controlled before and after interventional trial with one interventional site (KBTH) and a control site (37 Military hospital). Data will be collected over 19 months with a baseline phase of 7 months; an interventional phase of 5 months; and a post intervention phase of 7 months.
Intervention: The WHO multimodal hand hygiene strategy comprises five essential elements; system change-availability of alcohol-based hand rub at the point of care and/ or access to safe continuous water supply and soap and towels; training and education of healthcare professionals; monitoring of hand hygiene practices and performance feedback; reminders in the workplace; and the creation of a handhygiene safety culture with the participation of both individual healthcare workers and senior hospital managers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled before and after interventional trial
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Continuously monitoring of neonatal sepsis under standard of care at one site |
| Hand hygiene | Experimental | Combination Product: The WHO multimodal hand hygiene strategyThe WHO multimodal hand hygiene strategy is implemented at one site |
Who may qualify
- Ages
- 1 minute to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Admission NICU
- Birth weight ≥750 Grams
- ≤48 hours of age at time of enrolment
- Consent to participate obtained from legal guardian
Key exclusion criteria (2 listed)
- Neonates with severe congenital malformations
- Neonates who have undergone surgical procedure
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 |
|---|---|---|
| The WHO multimodal hand hygiene strategyAlso: Hand hygieneComprises five essential elements; system change-availability of alcohol-based hand rub at the point of care and/ or access to safe continuous water supply and soap and towels; training and education of healthcare professionals; monitoring of hand hygiene practices and performance feedback; reminders in the workplace; and the creation of a hand hygiene safety culture with the participation of both individual healthcare workers and senior hospital managers. | Combination product | Hand hygiene |
Primary outcome
Incidence of neonatal sepsis
Time frame: Post-intervention at 7 months
Incidence of neonatal sepsis including clinical cases treated as sepsis and cases of neonatal sepsis with confirmed bloodstream infections per 1000 admissions.
4 secondary outcomes
Rate of hand hygiene compliance per opportunity
Time frame: Post-intervention at 7 months
Rate of MDR Gram negative bacteria colonization among neonates
Time frame: During intervention at 2 months and post-intervention at 7 months
Length of admission in days
Time frame: Post-intervention at 7 months
All-cause mortality
Time frame: Post-intervention at 7 months
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 11 Oct 2021.
- Derived from this study: PubMed 34561387Labi AK, Enweronu-Laryea CC, Nartey ET, Bjerrum S, Ayibor PK, Andersen LP, Newman MJ, Kurtzhals JAL. Bloodstream Infections at Two Neonatal Intensive Care Units in Ghana: Multidrug Resistant Enterobacterales Undermine the Usefulness of Standard Antibiotic Regimes. Pediatr Infect Dis J. 2021 Dec 1;40(12):1115-1121. doi: 10.1097/INF.0000000000003284.
- Individual participant dataSharing planned: Undecided
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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.
Appiah Korang Labi, MD principal investigator
Department of Int. Health and Immunlogy Microbiology, University og Copenhagen
Jørgen Kurtzhals, Professor study director
Department of Int. Health and Immunlogy Microbiology, University og Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The WHO multimodal hand hygiene strategy in people with Neonatal SEPSIS, run by Stephanie Bjerrum at 1 site in Ghana.
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 4 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 11 Oct 2021. 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 Ghana. 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 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?
Incidence of neonatal sepsis (time frame: Post-intervention at 7 months). 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 NCT03755635, which also lists 1 linked publication.
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 Oct 2021.