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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Ghana1 site
  • Korle Bu Teaching Hospital

    Accra

Other trials in Ghana

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 groups in NCT03755635
Study groupRoleWhat they receive
Standard of careNo interventionContinuously monitoring of neonatal sepsis under standard of care at one site
Hand hygieneExperimentalThe 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.

  1. 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)
  1. 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

  2. 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

  3. Length of admission in days

    Days of admission

    Measured: Post-intervention at 7 months

  4. 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.

  1. First posted28 Nov 2018
  2. Study start1 Oct 2018
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

Resources

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)
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

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.

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